A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

NCT01427283 | Completed Phase 3

• 2 other identifiers: ONU37052011-005061-20
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 149

Brief Summary

The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and opioid-induced constipation who require around-the-clock opioid therapy.

Conditions

Low Back Pain

Keywords

Low back pain; Chronic pain; Opioid; Constipation; Moderate to severe

Outcome Measures

Primary Outcomes (1)

• Overall complete spontaneous bowel movement (CSBM) responder rates

  The overall Complete Spontaneous Bowel Movement (CSBM) responder rates over the 12 week double-blind period comparing OXN to OXY

  Weeks 1 through 12

Secondary Outcomes (2)

• CSBM Responder at least 50% of the weeks in the double-blind period

  Weeks 1 through 12

• Laxative-free Responder at least 50% of the weeks in the double-blind period

  Weeks 1 through 12

Study Arms (3)

OXN

EXPERIMENTAL

Oxycodone/Naloxone controlled-release tablets (OXN)

Drug: Oxycodone/Naloxone controlled-release

OXY

ACTIVE COMPARATOR

Oxycodone HCl controlled-release tablets (OXY)

Drug: Oxycodone HCl controlled-release

Placebo

PLACEBO COMPARATOR

Placebo tablets to match OXN or OXY

Drug: Placebo

Interventions

Oxycodone/Naloxone controlled-release DRUG

Oxycodone/Naloxone controlled-release tablets (10/5 - 40/20 mg) taken orally every 12 hours

OXN

Oxycodone HCl controlled-release DRUG

Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours

Also known as: OxyContin

OXY

Placebo DRUG

Placebo tablets to match OXN or OXY taken orally every 12 hours

Placebo

Eligibility Criteria

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

You may qualify if:

• Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period;
• The low back pain must be related to nonmalignant and nonneuropathic conditions and may be with or without radiation;
• Subjects must have a self-reported history of opioid induced constipation (OIC).

You may not qualify if:

• Subjects with rheumatoid arthritis or other inflammatory arthritis;
• Subjects with neuropathic conditions that have been painful or required therapy within the past 3 months;
• Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract or other significant conditions affecting GI motility;
• Subjects with chronic constipation not related to opioid use;
• Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or planned during the study;
• Subjects with a history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated.

Sponsors & Collaborators

• Purdue Pharma LP: lead

Study Sites (149)

Investigational Site

Alabaster, Alabama, 35007, United States

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Birmingham, Alabama, 35213, United States

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Birmingham, Alabama, 35216, United States

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Foley, Alabama, 36535, United States

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Mobile, Alabama, 36608, United States

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Mesa, Arizona, 85202, United States

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Phoenix, Arizona, 85020, United States

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Phoenix, Arizona, 85021, United States

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Sun Lakes, Arizona, 85248, United States

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Tucson, Arizona, 85704, United States

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Tucson, Arizona, 85712, United States

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Little Rock, Arkansas, 72211, United States

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Sherwood, Arkansas, 72120, United States

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Anaheim, California, 92801, United States

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Anaheim, California, 92804, United States

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Artesia, California, 90701, United States

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Cerritos, California, 90703, United States

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Chino, California, 91710, United States

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El Cajon, California, 92020, United States

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Encino, California, 91436, United States

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Fountain Valley, California, 92708, United States

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Fresno, California, 93720, United States

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Garden Grove, California, 92843, United States

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Garden Grove, California, 92844, United States

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Laguna Hills, California, 92653, United States

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Lakewood, California, 90712, United States

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Lincoln, California, 95648, United States

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Lomita, California, 90717, United States

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Long Beach, California, 90806, United States

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Oceanside, California, 92054, United States

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Orange, California, 92868, United States

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Paramount, California, 90723, United States

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Sacramento, California, 95823, United States

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San Bernardino, California, 92408, United States

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San Diego, California, 92103, United States

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San Diego, California, 92114, United States

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Thousand Oaks, California, 91360, United States

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Torrance, California, 90509, United States

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Colorado Springs, Colorado, 80907, United States

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Colorado Springs, Colorado, 80909, United States

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Denver, Colorado, 80246, United States

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Golden, Colorado, 80401, United States

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Aventura, Florida, 33180, United States

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Bradenton, Florida, 34209, United States

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Chiefland, Florida, 32626, United States

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Clermont, Florida, 34711, United States

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Daytona Beach, Florida, 32117, United States

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DeLand, Florida, 32720, United States

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Edgewater, Florida, 32132, United States

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Fort Lauderdale, Florida, 33316, United States

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Fort Myers, Florida, 33916, United States

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Hialeah, Florida, 33010, United States

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Hialeah, Florida, 33012, United States

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Inverness, Florida, 34452, United States

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Jacksonville, Florida, 32216, United States

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Jacksonville, Florida, 32256, United States

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Jacksonville, Florida, 32257, United States

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Miami, Florida, 33015, United States

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Miami, Florida, 33125, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33135, United States

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Miami, Florida, 33136, United States

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Miami, Florida, 33144, United States

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Miami, Florida, 33145, United States

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Miami, Florida, 33155, United States

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Miami, Florida, 33165, United States

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Miami, Florida, 33185, United States

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Miami Beach, Florida, 33140, United States

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Naples, Florida, 34110, United States

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Naples, Florida, 34113, United States

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New Smyrna Beach, Florida, 32168, United States

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North Miami, Florida, 33161, United States

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Oldsmar, Florida, 34677, United States

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Orlando, Florida, 32806, United States

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Oviedo, Florida, 32765, United States

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Plantation, Florida, 33317, United States

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Tamarac, Florida, 33321, United States

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Tampa, Florida, 33607, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30308, United States

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Austell, Georgia, 30106, United States

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Snellville, Georgia, 30078, United States

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Boise, Idaho, 83704, United States

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Boise, Idaho, 83713, United States

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Chicago, Illinois, 60616, United States

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Chicago, Illinois, 60622, United States

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Chicago, Illinois, 60657, United States

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Evansville, Indiana, 47714, United States

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Indianapolis, Indiana, 46250, United States

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Michigan City, Indiana, 46360, United States

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Wichita, Kansas, 67203, United States

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Edgewood, Kentucky, 41017, United States

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Lake Charles, Louisiana, 70601, United States

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Monroe, Louisiana, 71201, United States

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New Orleans, Louisiana, 70119, United States

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Pikesville, Maryland, 21208, United States

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Brockton, Massachusetts, 02301, United States

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Worcester, Massachusetts, 01605, United States

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Florissant, Missouri, 63031, United States

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Las Vegas, Nevada, 89119, United States

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Atco, New Jersey, 08004, United States

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Great Neck, New York, 11023, United States

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Kew Gardens, New York, 11415, United States

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New York, New York, 10023, United States

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Rochester, New York, 14618, United States

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Williamsville, New York, 14221, United States

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Durham, North Carolina, 27710, United States

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Elkin, North Carolina, 28621, United States

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High Point, North Carolina, 27262, United States

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Winston-Salem, North Carolina, 27103, United States

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Columbus, Ohio, 43213, United States

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Dayton, Ohio, 45406, United States

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Moraine, Ohio, 45439, United States

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Toledo, Ohio, 43614, United States

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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73109, United States

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Oklahoma City, Oklahoma, 73119, United States

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Eugene, Oregon, 97404, United States

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Jenkintown, Pennsylvania, 19046, United States

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Levittown, Pennsylvania, 19056, United States

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Mechanicsburg, Pennsylvania, 17055, United States

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Pittsburgh, Pennsylvania, 15215, United States

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Red Lion, Pennsylvania, 17356, United States

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State College, Pennsylvania, 16801, United States

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Warwick, Rhode Island, 02886, United States

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Charleston, South Carolina, 29406, United States

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Myrtle Beach, South Carolina, 29588, United States

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Rapid City, South Dakota, 57702, United States

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Jackson, Tennessee, 38305, United States

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Allen, Texas, 75013, United States

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Austin, Texas, 78731, United States

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Dallas, Texas, 75203, United States

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Dallas, Texas, 75218, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75251, United States

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Houston, Texas, 77062, United States

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Houston, Texas, 77065, United States

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Houston, Texas, 77074, United States

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Houston, Texas, 77098, United States

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McKinney, Texas, 75070, United States

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North Richland Hills, Texas, 76180, United States

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Tomball, Texas, 77375, United States

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Orem, Utah, 84058, United States

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Salt Lake City, Utah, 84102, United States

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Salt Lake City, Utah, 84124, United States

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Danville, Virginia, 24541, United States

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Midlothian, Virginia, 23114, United States

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Richmond, Virginia, 23220, United States

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Bothell, Washington, 98011, United States

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MeSH Terms

Conditions

Low Back Pain; Chronic Pain; Constipation

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: September 1, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 12, 2015

Record last verified: 2015-02

Locations

US (149)