Open Label Safety Study of Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed Gastroesophageal Reflux Disease (GERD)

NCT00868296 | Completed Phase 3 Results

• 1 other identifier: 3001B3-335
• Study Type: interventional
• Target: 58
• Locations: 11 countries
• Sites: 71

Brief Summary

The purpose of this study is to provide additional information on safety and tolerability after multiple does of pantoprazole. Only patients who successfully completed the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) are eligible to participate in this study.

Conditions

Gastroesophageal Reflux

Keywords

Safety

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Laboratory Test Values of Potential Clinical Importance During Treatment Period

  Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Criteria are as follows: Potassium ≤ 3.0 mEq/L or ≥ 6.2 mEq/L; Carbon dioxide \< 12 mEq/L or \> 35 mEq/L; Total bilirubin \> 1.5xULN; CPK \> 3xULN; Gastrin ≥ 600 pg/mL; Neutrophils \< 10% or \> 80%; Platelet count \< 100 x10 to the third power/ul or \> 600 x10 to the third power/ul; Urine protein albumin \> 2+ (dipstick) 100mg/dL or positive; Urine leukocyte esterase \> 2+ (dipstick) moderate or positive.

  6 weeks

• Growth Parameters Z-scores

  Z-Score is a statistical measure to evaluate how a single data point compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores primarily range from -3 to +3. A Z-score of 0 indicates the same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. In this study, infant growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

  6 weeks

Study Arms (2)

Low dose

ACTIVE COMPARATOR

Drug: pantoprazole

High dose

ACTIVE COMPARATOR

Drug: pantoprazole

Interventions

pantoprazole DRUG

High dose; Low dose

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Successful completion of the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) Study.

You may not qualify if:

• Patients requiring chronic use of warfarin, carbamepazine, or phenytoin.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (71)

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Phoenix, Arizona, 85006, United States

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Loma Linda, California, 92354, United States

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Oakland, California, 94609-1809, United States

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Orange, California, 92868, United States

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Sacramento, California, 95817, United States

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San Diego, California, 92103, United States

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New Haven, Connecticut, 06520-8064, United States

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

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Gainesville, Florida, 32610-0296, United States

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Miami, Florida, 33101, United States

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Sunrise, Florida, 33323, United States

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Atlanta, Georgia, 30322, United States

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Honolulu, Hawaii, 96826, United States

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Boise, Idaho, 83704, United States

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Chicago, Illinois, 60614, United States

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Park Ridge, Illinois, 60068, United States

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Lexington, Kentucky, 40536-0284, United States

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Louisville, Kentucky, 40202, United States

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New Orleans, Louisiana, 70121, United States

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Baltimore, Maryland, 21201, United States

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Boston, Massachusetts, 02114, United States

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Flint, Michigan, 48503, United States

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Omaha, Nebraska, 68105, United States

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Camden, New Jersey, 08103, United States

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New Brunswick, New Jersey, 08901, United States

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Newark, New Jersey, 07103, United States

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Albany, New York, 12208, United States

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Brooklyn, New York, 11219, United States

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New York, New York, 10032, United States

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The Bronx, New York, 10467, United States

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Valhalla, New York, 10595-1689, United States

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Durham, North Carolina, 27710, United States

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Winston-Salem, North Carolina, 27157, United States

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Oklahoma City, Oklahoma, 73104, United States

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Portland, Oregon, 97239-3042, United States

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Danville, Pennsylvania, 17822-1320, United States

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Memphis, Tennessee, 38163, United States

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Nashville, Tennessee, 37232-9550, United States

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Dallas, Texas, 75390-9063, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84113, United States

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Burlington, Vermont, 05401, United States

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Richmond, Virginia, 23298, United States

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Morgantown, West Virginia, 26506, United States

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Milwaukee, Wisconsin, 53226, United States

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Brisbane, Australia

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Edegem, 2650, Belgium

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Leuven, 3000, Belgium

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Vancouver, British Columbia, V6H 3V4, Canada

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Ottawa, Ontario, K1Y 4E9, Canada

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Toronto, Ontario, M5G 1X8, Canada

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Montreal, Quebec, H3H 1P3, Canada

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Sainte-Foy, Quebec, G1V 4G2, Canada

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Paris, 75674, France

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Paris, 75935, France

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Bochum, 44797, Germany

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Osnabrück, 49074, Germany

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Potsdam, 14467, Germany

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Brescia, 25123, Italy

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Napoli, 80121, Italy

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Roma, 00161, Italy

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Rotterdam, 3015 GJ, Netherlands

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Bydgoszcz, 85-165, Poland

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Krakow, 33-663, Poland

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Lublin, 20-093, Poland

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Panorama, CPT, 7500, South Africa

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Pietermaritzburg, KwaZulu-Natal, 3235, South Africa

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Durban, 3630, South Africa

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Overport, 4067, South Africa

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Pretoria, 0083, South Africa

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Zurich, 8032, Switzerland

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MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: U. S. Contact Center
• Organization: Wyeth

clintrialresults@wyeth.com

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For Belgium, trials-BEL@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Germany, medinfoDEU@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Netherlands, trials-NL@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Poland, WPWZMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For South Africa, ZAFinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Australia, medinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For France, infomedfrance@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Italy, descresg@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Switzerland, med@wyeth.com

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 20, 2009
• First Posted: March 24, 2009
• Study Start: March 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: May 4, 2010
• Results First Posted: January 7, 2010

Record last verified: 2010-04

Locations

US (45); CA (5); DE (3); CH (1); PL (3); AU (1); IT (3); BE (2); NL (1); ZA (5); FR (2)