Intravenous And Oral Casopitant (GW679769) For The Prevention Of Chemotherapy Induced Nausea And Vomiting

NCT00366834 | Completed Phase 3

• 1 other identifier: NKV102549
• Study Type: interventional
• Target: 1,840
• Locations: 31 countries
• Sites: 221

Brief Summary

This is a Phase III trial designed to demonstrate that casopitant (GW679769) plus dexamethasone and ondansetron is more effective in the prevention of vomiting than dexamethasone and ondansetron alone following the administration of moderately emetogenic chemotherapy.

Conditions

Vomiting; Nausea; Nausea and Vomiting, Chemotherapy-Induced

Keywords

Anthracycline; Cyclophosphamide; Moderately; Nausea; Emetogenic; Vomiting

Outcome Measures

Primary Outcomes (1)

• Complete response as assessed by a visual analogue scale and a subject diary over the 120 hours following the first cycle of chemotherapy.

  120 Hours

Secondary Outcomes (18)

• Complete response over 120 hours following subsequent chemotherapy cycles Use of rescue medication over 120 hours following all chemotherapy cycles Impact on daily life activities over 120 hours, assessed using a subject diary questionnaire

  120 Hours

• The proportion of subjects who achieve a complete response during the acute (0-24 hours) and the delayed (24-120 hours) phase following the first cycle of MEC.

  approx. 18 mos

• The proportion of subjects who achieve a complete response over the first 120 hours, during the acute (0-24 hours), the delayed (24-120 hours), and the overall (0-120 hours) phase following subsequent cycles of MEC.

  approx. 18 mos

• Maximum nausea score (to assess the severity of nausea), as assessed by a Visual Analogue Scale (VAS) over the first 120 hours and in the acute and delayed phases following each cycle of MEC.

  approx. 18 mos

• Time to first antiemetic rescue medication, defined as the time elapsed from the start of administration of the MEC regimen to the first use of antiemetic rescue medication.

  approx. 18 mos

Study Arms (4)

Control

PLACEBO COMPARATOR

ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV on Day 1 + placebo

Drug: Dexamethasone intravenous; Drug: Ondansetron oral tablets; Drug: placebo

Single dose oral

EXPERIMENTAL

ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV + casopitant 150 mg on Day 1

Drug: Casopitant (GW679769) oral tablets; Drug: Dexamethasone intravenous; Drug: Ondansetron oral tablets

3-day oral

EXPERIMENTAL

ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV + casopitant 150 mg on Day 1 + 50 mg on days 2 \& 3

Drug: Casopitant (GW679769) oral tablets; Drug: Dexamethasone intravenous; Drug: Ondansetron oral tablets

3-day IV/oral

EXPERIMENTAL

ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV on Day 1 + 90 mg IV casopitant on day 1 and 50 mg oral casopitant on days 2 \& 3

Drug: Casopitant (GW679769) oral tablets; Drug: Casopitant (GW679769) intravenous; Drug: Dexamethasone intravenous; Drug: Ondansetron oral tablets

Interventions

Casopitant (GW679769) oral tablets DRUG

3-day IV/oral; 3-day oral; Single dose oral

Casopitant (GW679769) intravenous DRUG

3-day IV/oral

Dexamethasone intravenous DRUG

3-day IV/oral; 3-day oral; Control; Single dose oral

Ondansetron oral tablets DRUG

Also known as: Dexamethasone intravenous, Casopitant (GW679769) oral tablets, Casopitant (GW679769) intravenous

3-day IV/oral; 3-day oral; Control; Single dose oral

placebo DRUG

casopitant placebo

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject understands the nature and purpose of this study and the study procedures and has signed an informed consent form for this study to indicate this understanding.
• At least 18 years of age.
• Is scheduled to receive their first course of an anthracycline and cyclophosphamide containing moderately emetogenic chemotherapy regimen for the treatment of a solid malignant tumor as outlined in Section 8.1.1.
• Has an ECOG performance status of 0, 1, or 2.
• Hematologic and metabolic status must be adequate for receiving a moderately emetogenic regimen and meet the following criteria:
• Total Neutrophils ≥ 1500/mm³(Standard units : ≥1.5 x 10\^9/L)
• Platelets ≥ 100,000/mm³ (Standard units: ≥100.0 x 10\^9/L)
• Bilirubin ≤ 1.5 x ULN
• Liver enzymes must be below the following limits:
• Without known liver metastases: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal.
• With known liver metastases: AST and/or ALT ≤ 5.0 x upper limit of normal.
• Is willing and able to complete daily components of the subject diary for each study cycle.
• Women of childbearing potential; must commit to consistent and correct use of an acceptable method of birth control; GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of a physician, are as follows:
• Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal. For purposes of this study, postmenopausal is defined as one year without menses)
• child-bearing potential: must have a negative serum pregnancy test result or negative urine dipstick pregnancy test within 24 hours prior to the first dose of investigational product of Cycle 1, Day 1 and agrees to one of the following:

You may not qualify if:

• Has previously received cytotoxic chemotherapy. A history of previous biological or hormonal therapy will be permitted.
• Is a female subject who is pregnant or lactating.
• Has received radiation therapy to the brain, abdomen, or pelvis in the ten days prior to the first dose of study medication or casopitant investigational product and/or will receive radiation therapy to the brain, abdomen, or the pelvis in the six days following the first dose of study medication (ZOFRAN and dexamethasone) or casopitant investigational product.
• Is scheduled to receive taxane therapy during cycle 1. Note that subjects will be permitted to receive taxane therapy in conjunction with one of the allowed MEC regimens during subsequent cycles.
• Has experienced emesis (i.e., vomiting and/or retching) or clinically significant nausea in the 24 hours preceding the first dose of study medication or casopitant investigational product.
• Has a known central nervous system primary or metastatic malignancy, unless successfully treated with excision or radiation and has been medically stable for at least 1 week prior to receiving the first dose of study medication or casopitant investigational product.
• Has history of documented peptic ulcer disease (via endoscopy or x-ray), active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, or any uncontrolled medical condition (other than malignancy) which in the opinion of the Investigator may confound the results of the study, represent another potential etiology for emesis and nausea (other than CINV) or pose an unwarranted risk to the subject.
• Has a known hypersensitivity or contraindication to ZOFRAN, another 5-HT3 receptor antagonist, dexamethasone, or any component of casopitant.
• Has previously received an NK-1 receptor antagonist.
• Received an investigational drug in the previous 30 days or is scheduled to receive any investigational drug other than casopitant during the study period.
• Has taken/received any medication of moderate or high emetogenic potential within the 48 hours prior to the first dose of study medication or casopitant investigational product. Opioid narcotics for cancer pain will be permitted if the subject has been on a stable dose and has not experienced emesis or nausea from the narcotics.
• Has taken/received any medication with known or potential antiemetic activity within the 24-hour period prior to receiving study drug. This includes, but is not limited to:
• HT3 receptor antagonists (e.g., ondansetron, granisetron, dolasetron, tropisetron, ramosetron). Palonestron is not permitted within 7 days prior to administration of investigational product.
• benzamide / benzamide derivatives (e.g., metoclopramide, alizapride)
• benzodiazepines (except if the subject is receiving such medication for sleep or anxiety and has been on a stable dose for at least seven days prior to the first dose of casopitant investigational product; however, lorazepam is prohibited 24 hours prior to receiving study drug regardless of reason for use)

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (223)

GSK Investigational Site

Birmingham, Alabama, 35209, United States

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GSK Investigational Site

Birmingham, Alabama, 35233, United States

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GSK Investigational Site

Glendale, Arizona, 85304, United States

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GSK Investigational Site

Fayetteville, Arkansas, 72703, United States

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GSK Investigational Site

Hot Springs, Arkansas, 71913, United States

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GSK Investigational Site

Jonesboro, Arkansas, 72401, United States

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GSK Investigational Site

Concord, California, 94520, United States

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GSK Investigational Site

Fountain Valley, California, 92708, United States

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GSK Investigational Site

Fresno, California, 93710, United States

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GSK Investigational Site

Greenbrae, California, 94904-2007, United States

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GSK Investigational Site

La Verne, California, 91750, United States

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GSK Investigational Site

Los Angeles, California, 90057, United States

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GSK Investigational Site

Orange, California, 92868, United States

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GSK Investigational Site

Poway, California, 92064, United States

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GSK Investigational Site

San Diego, California, 92121, United States

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GSK Investigational Site

Soquel, California, 95073, United States

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GSK Investigational Site

Norwich, Connecticut, 06360, United States

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GSK Investigational Site

Washington D.C., District of Columbia, 20010, United States

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GSK Investigational Site

Boynton Beach, Florida, 33435, United States

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GSK Investigational Site

Brooksville, Florida, 34613, United States

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GSK Investigational Site

Fort Lauderdale, Florida, 33316, United States

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GSK Investigational Site

Fort Lauderdale, Florida, 33328, United States

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GSK Investigational Site

Inverness, Florida, 34452, United States

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GSK Investigational Site

Miami, Florida, 33179, United States

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GSK Investigational Site

New Port Richey, Florida, 34652, United States

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GSK Investigational Site

Tamarac, Florida, 33321, United States

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GSK Investigational Site

Tampa, Florida, 33614, United States

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GSK Investigational Site

West Palm Beach, Florida, 33401, United States

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GSK Investigational Site

Augusta, Georgia, 30912, United States

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GSK Investigational Site

Columbus, Georgia, 31904, United States

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GSK Investigational Site

Lawrenceville, Georgia, 30045, United States

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GSK Investigational Site

Centralia, Illinois, 62801, United States

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GSK Investigational Site

Galesburg, Illinois, 61401, United States

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GSK Investigational Site

Skokie, Illinois, 60076, United States

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GSK Investigational Site

Evansville, Indiana, 47713, United States

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GSK Investigational Site

Muncie, Indiana, 47303, United States

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GSK Investigational Site

Terre Haute, Indiana, 47804, United States

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GSK Investigational Site

Mason City, Iowa, 50401, United States

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GSK Investigational Site

Hazard, Kentucky, 41701, United States

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GSK Investigational Site

Lexington, Kentucky, 40503, United States

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GSK Investigational Site

Alexandria, Louisiana, 71301, United States

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GSK Investigational Site

Baton Rouge, Louisiana, 70809, United States

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GSK Investigational Site

Metairie, Louisiana, 70006, United States

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GSK Investigational Site

Baltimore, Maryland, 21229-5299, United States

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GSK Investigational Site

Baltimore, Maryland, 21237, United States

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GSK Investigational Site

Pittsfield, Massachusetts, 01201, United States

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GSK Investigational Site

Worcester, Massachusetts, 01608, United States

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GSK Investigational Site

Clinton Township, Michigan, 48038, United States

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GSK Investigational Site

Free Soil, Michigan, 49411, United States

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GSK Investigational Site

Saint Joseph, Michigan, 49085, United States

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GSK Investigational Site

Troy, Michigan, 48085, United States

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GSK Investigational Site

Hattiesburg, Mississippi, 39401, United States

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GSK Investigational Site

Tupelo, Mississippi, 38801, United States

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GSK Investigational Site

Jefferson City, Missouri, 65109, United States

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GSK Investigational Site

Rolla, Missouri, 65401, United States

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GSK Investigational Site

St Louis, Missouri, 63141, United States

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GSK Investigational Site

Billings, Montana, 59101, United States

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GSK Investigational Site

Great Falls, Montana, 59405, United States

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GSK Investigational Site

Denville, New Jersey, 07834, United States

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GSK Investigational Site

Newark, New Jersey, 07112, United States

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GSK Investigational Site

Somerville, New Jersey, 08876, United States

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GSK Investigational Site

Sparta, New Jersey, 07871, United States

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GSK Investigational Site

Albuquerque, New Mexico, 87109, United States

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GSK Investigational Site

Buffalo, New York, 14215, United States

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GSK Investigational Site

Durham, North Carolina, 27710, United States

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GSK Investigational Site

Winston-Salem, North Carolina, 27103, United States

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GSK Investigational Site

Bismarck, North Dakota, 58501, United States

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GSK Investigational Site

Akron, Ohio, 44304, United States

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GSK Investigational Site

Bethlehem, Pennsylvania, 18015, United States

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GSK Investigational Site

Hershey, Pennsylvania, 17033, United States

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GSK Investigational Site

Sayre, Pennsylvania, 18840, United States

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GSK Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

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GSK Investigational Site

Sumter, South Carolina, 29150, United States

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GSK Investigational Site

Corpus Christi, Texas, 78412, United States

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GSK Investigational Site

Corpus Christi, Texas, 78463-3069, United States

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GSK Investigational Site

Dallas, Texas, 75237, United States

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GSK Investigational Site

Richardson, Texas, 75080, United States

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GSK Investigational Site

Logan, Utah, 84341, United States

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GSK Investigational Site

Ogden, Utah, 84403, United States

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GSK Investigational Site

Burlington, Vermont, 05401, United States

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GSK Investigational Site

Everett, Washington, 98201, United States

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GSK Investigational Site

Spokane, Washington, 99204, United States

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GSK Investigational Site

Tacoma, Washington, 98405, United States

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GSK Investigational Site

Huntington, West Virginia, 25701, United States

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GSK Investigational Site

Huntington, West Virginia, 25705, United States

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GSK Investigational Site

Madison, Wisconsin, 53717, United States

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GSK Investigational Site

Capital Federal, Buenos Aires, C1405CUB, Argentina

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GSK Investigational Site

Mendoza, Mendoza Province, M5500AYB, Argentina

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GSK Investigational Site

Rosario, Santa Fe Province, S2000KZE, Argentina

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GSK Investigational Site

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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GSK Investigational Site

Quilmes, 1878, Argentina

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GSK Investigational Site

Salzburg, A-5020, Austria

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GSK Investigational Site

Sankt Pölten, A-3100, Austria

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GSK Investigational Site

Vienna, A-1090, Austria

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GSK Investigational Site

Vienna, A-1130, Austria

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GSK Investigational Site

Vöcklabruck, A-4840, Austria

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GSK Investigational Site

Brussels, 1070, Belgium

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GSK Investigational Site

Ghent, 9000, Belgium

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GSK Investigational Site

Ottignies, 1340, Belgium

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GSK Investigational Site

Plovdiv, 4000, Bulgaria

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GSK Investigational Site

Shumen, 9700, Bulgaria

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GSK Investigational Site

Sofia, 1527, Bulgaria

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GSK Investigational Site

Vancouver, British Columbia, V5Z 4E6, Canada

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GSK Investigational Site

Moncton, New Brunswick, E1C 8X3, Canada

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GSK Investigational Site

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

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GSK Investigational Site

Oshawa, Ontario, L1G 2B9, Canada

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GSK Investigational Site

Thunder Bay, Ontario, P7B 6V4, Canada

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GSK Investigational Site

Toronto, Ontario, M5G 1X5, Canada

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GSK Investigational Site

Toronto, Ontario, M5G2M9, Canada

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GSK Investigational Site

Windsor, Ontario, N8W 2X3, Canada

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GSK Investigational Site

Charlottetown, Prince Edward Island, C1A 8T5, Canada

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GSK Investigational Site

Greenfield Park, Quebec, J4V 2H1, Canada

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GSK Investigational Site

Laval, Quebec, H7M 3L9, Canada

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GSK Investigational Site

Lévis, Quebec, G6V 3Z1, Canada

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GSK Investigational Site

Montreal, Quebec, H1T 2M4, Canada

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GSK Investigational Site

Québec, Quebec, G1J 1Z4, Canada

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GSK Investigational Site

Sherbrooke, Quebec, J1H 5N4, Canada

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GSK Investigational Site

Saskatoon, Saskatchewan, S7N 4H4, Canada

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GSK Investigational Site

Zagreb, 10 000, Croatia

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GSK Investigational Site

Brno, 656 53, Czechia

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GSK Investigational Site

Chomutov, 43012, Czechia

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GSK Investigational Site

Ostrava - Poruba, 708 52, Czechia

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GSK Investigational Site

Pardubice, 532 03, Czechia

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GSK Investigational Site

Prague, 100 00, Czechia

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GSK Investigational Site

Tábor, 390 19, Czechia

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GSK Investigational Site

Ústí nad Labem, 40113, Czechia

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GSK Investigational Site

Herlev, 2730, Denmark

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GSK Investigational Site

Hilleroed, 3400, Denmark

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GSK Investigational Site

Tallinn, 11619, Estonia

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GSK Investigational Site

Tartu, 51003, Estonia

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GSK Investigational Site

Heidelberg, Baden-Wurttemberg, 69126, Germany

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GSK Investigational Site

Ingolstadt, Bavaria, 85049, Germany

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GSK Investigational Site

Munich, Bavaria, 80335, Germany

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GSK Investigational Site

Munich, Bavaria, 81925, Germany

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GSK Investigational Site

Würzburg, Bavaria, 97070, Germany

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GSK Investigational Site

Hamburg, Hamburg, 20357, Germany

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GSK Investigational Site

Hamburg, Hamburg, 22081, Germany

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GSK Investigational Site

Hamburg, Hamburg, 22457, Germany

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GSK Investigational Site

Kassel, Hesse, 34119, Germany

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GSK Investigational Site

Würselen, North Rhine-Westphalia, 52146, Germany

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GSK Investigational Site

Berlin, State of Berlin, 10367, Germany

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GSK Investigational Site

Berlin, State of Berlin, 12163, Germany

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GSK Investigational Site

Bad Berka, Thuringia, 99437, Germany

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GSK Investigational Site

Jena, Thuringia, 07743, Germany

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GSK Investigational Site

Athens, 115 22, Greece

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GSK Investigational Site

Athens, 115 28, Greece

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GSK Investigational Site

Kavala, 65403, Greece

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GSK Investigational Site

Pátrai, 26500, Greece

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GSK Investigational Site

Thessaloniki, 54636, Greece

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GSK Investigational Site

Hong Kong, Hong Kong

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GSK Investigational Site

Shatin, Hong Kong

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GSK Investigational Site

Tuenmen, Hong Kong

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GSK Investigational Site

Wan Chai, Hong Kong

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GSK Investigational Site

Győr, 9023, Hungary

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GSK Investigational Site

Gyula, 5700, Hungary

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GSK Investigational Site

Veszprém, 8200, Hungary

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GSK Investigational Site

Pune, 411001, India

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GSK Investigational Site

Dublin, 4, Ireland

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GSK Investigational Site

Dublin, 8, Ireland

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GSK Investigational Site

Dublin, 9, Ireland

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GSK Investigational Site

Tallaght, Dublin, 24, Ireland

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GSK Investigational Site

Wilton, Cork, Ireland

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GSK Investigational Site

Benevento, Campania, 82100, Italy

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GSK Investigational Site

Rome, Lazio, 00184, Italy

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GSK Investigational Site

Genoa, Liguria, 16132, Italy

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GSK Investigational Site

Sanremo (IM), Liguria, 18038, Italy

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GSK Investigational Site

Sassari, Sardinia, 07100, Italy

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GSK Investigational Site

Perugia, Umbria, 06156, Italy

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GSK Investigational Site

Liepāja, LV3401, Latvia

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GSK Investigational Site

Riga, LV 1002, Latvia

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GSK Investigational Site

Riga, LV 1079, Latvia

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GSK Investigational Site

Kaunas, LT-45434, Lithuania

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GSK Investigational Site

Klaipėda, LT-92228, Lithuania

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GSK Investigational Site

Vilnius, LT-08660, Lithuania

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GSK Investigational Site

Durango, Durango, 34079, Mexico

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GSK Investigational Site

Mérida, Yucatán, 97500, Mexico

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GSK Investigational Site

Lahore, Pakistan

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GSK Investigational Site

Lima, Lima Province, Lima 13, Peru

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Lima, Lima Province, Lima 34, Peru

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GSK Investigational Site

Callao, Callao 2, Peru

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GSK Investigational Site

Cebu, 6000, Philippines

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Manila, 1000, Philippines

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GSK Investigational Site

Quezon City, 1100, Philippines

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GSK Investigational Site

Santa Cruz, Manila, 1012, Philippines

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GSK Investigational Site

Krakow, 31-115, Poland

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GSK Investigational Site

Moscow, 115 478, Russia

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GSK Investigational Site

Moscow, 115478, Russia

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GSK Investigational Site

Moscow, 117997, Russia

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GSK Investigational Site

Moscow Region, 143 423, Russia

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GSK Investigational Site

Saint Petersburg, 198255, Russia

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GSK Investigational Site

Samara, 443066, Russia

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GSK Investigational Site

Yaroslavl, 150054, Russia

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GSK Investigational Site

Bratislava, 812 50, Slovakia

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GSK Investigational Site

Bratislava, 833 10, Slovakia

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GSK Investigational Site

Nitra, 949 01, Slovakia

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GSK Investigational Site

Poprad, 058 01, Slovakia

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GSK Investigational Site

Žilina, 010 01, Slovakia

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GSK Investigational Site

Athlone Park, Amanzimtoti, 4126, South Africa

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GSK Investigational Site

Bloemfontein, 9301, South Africa

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GSK Investigational Site

Observatory, 7925, South Africa

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GSK Investigational Site

Panorama, 7500, South Africa

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GSK Investigational Site

Parktown, 2193, South Africa

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GSK Investigational Site

Saxonwold, Johannesburg, 2196, South Africa

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GSK Investigational Site

Seoul, 110-744, South Korea

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GSK Investigational Site

Seoul, 120-752, South Korea

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GSK Investigational Site

Donostia / San Sebastian, 20012, Spain

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GSK Investigational Site

Madrid, 28034, Spain

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GSK Investigational Site

Ourense, 32005, Spain

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GSK Investigational Site

Santiago de Compostela, 15706, Spain

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GSK Investigational Site

Segovia, 40002, Spain

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GSK Investigational Site

Zamora, Spain

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GSK Investigational Site

Kaohsiung City, 807, Taiwan

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GSK Investigational Site

Tainan, 704, Taiwan

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GSK Investigational Site

Taipei, 114, Taiwan

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GSK Investigational Site

Taipei, Taiwan

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GSK Investigational Site

Bangkok, 10400, Thailand

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GSK Investigational Site

Chelmsford, Essex, CM1 7ET, United Kingdom

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GSK Investigational Site

Aberdeen, AB25 2ZN, United Kingdom

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GSK Investigational Site

London, EC1A 7BE, United Kingdom

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GSK Investigational Site

London, SE1 9RT, United Kingdom

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GSK Investigational Site

Maidstone, ME16 9QQ, United Kingdom

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GSK Investigational Site

Nottingham, NG5 1PB, United Kingdom

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GSK Investigational Site

Shrewsbury, SY3 8XQ, United Kingdom

Location

Related Publications (1)

• Herrstedt J, Apornwirat W, Shaharyar A, Aziz Z, Roila F, Van Belle S, Russo MW, Levin J, Ranganathan S, Guckert M, Grunberg SM. Phase III trial of casopitant, a novel neurokinin-1 receptor antagonist, for the prevention of nausea and vomiting in patients receiving moderately emetogenic chemotherapy. J Clin Oncol. 2009 Nov 10;27(32):5363-9. doi: 10.1200/JCO.2009.21.8511. Epub 2009 Oct 5.

  PMID: 19805683 RESULT

MeSH Terms

Conditions

Vomiting; Nausea

Interventions

casopitant; Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2006
• First Posted: August 21, 2006
• Study Start: July 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2009
• Last Updated: September 10, 2012

Record last verified: 2012-06

Locations

IN (1); PL (1); BU (3); ES (6); RU (7); HU (3); ME (2); AR (5); HK (4); KR (2); PA (1); IT (6); DE (14); LA (3); GR (5); TH (1); SL (5); TW (4); CR (1); LI (3); IE (5); AU (5); GB (7); CA (16); DK (2); CZ (7); BE (3); PH (4); PE (3); ZA (6); US (86)