Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Treatment-Withdrawal Study of the Efficacy and Safety of Pantoprazole Sodium Enteric-Coated Granules in Infants (1 Through 11 Months) With Symptomatic GERD.
1 other identifier
interventional
129
1 country
38
Brief Summary
To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2006
Shorter than P25 for phase_3
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2006
CompletedFirst Posted
Study publicly available on registry
August 17, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedResults Posted
Study results publicly available
January 7, 2010
CompletedMay 4, 2010
April 1, 2010
1.2 years
August 16, 2006
November 30, 2009
April 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients Withdrawn From Study Due to Lack of Efficacy.
Lack of efficacy defined as 1 or more of the following occurring during the double blind treatment-withdrawal phase: significant worsening of gastroesophageal reflux disease (GERD) symptoms frequency, a diagnostic test (e.g., endoscopy) demonstrating worsening of esophagitis, maximal antacid intake for ≥ 7 continuous days, or severe GERD symptoms based on physician's judgment.
4 weeks double-blind
Study Arms (2)
Pantoprazole
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- term or post term infants beyond the neonatal period of an age greater than 28 days but less than or equal to 11 months
- clinical diagnosis of GERD
- weight greater than 2.5 kg and less than or equal to 15 kg
You may not qualify if:
- known history of upper GI anatomic disorders
- history of acute life-threatening medical conditions
- clinically significant medical conditions or laboratory abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Unknown Facility
Mobile, Alabama, 36604, United States
Unknown Facility
Phoenix, Arizona, 85016, United States
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Oakland, California, 94609, United States
Unknown Facility
Orange, California, 92868, United States
Unknown Facility
Washington D.C., District of Columbia, 20010, United States
Unknown Facility
Miami, Florida, 33101, United States
Unknown Facility
Orlando, Florida, 32801, United States
Unknown Facility
Pensacola, Florida, 32504, United States
Unknown Facility
Tampa, Florida, 33606, United States
Unknown Facility
Augusta, Georgia, 30912, United States
Unknown Facility
Peoria, Illinois, 61603, United States
Unknown Facility
Bardstown, Kentucky, 40004, United States
Unknown Facility
Louisville, Kentucky, 40202, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Flint, Michigan, 48503, United States
Unknown Facility
Jackson, Mississippi, 39216, United States
Unknown Facility
Omaha, Nebraska, 68105, United States
Unknown Facility
Las Vegas, Nevada, 89109, United States
Unknown Facility
Camden, New Jersey, 08103, United States
Unknown Facility
Mays Landing, New Jersey, 08330, United States
Unknown Facility
Morristown, New Jersey, 07962, United States
Unknown Facility
Brooklyn, New York, 11219, United States
Unknown Facility
Buffalo, New York, 14222, United States
Unknown Facility
Valhalla, New York, 10595, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Cincinnati, Ohio, 45229, United States
Unknown Facility
Oklahoma City, Oklahoma, 73104, United States
Unknown Facility
Bethlehem, Pennsylvania, 18017, United States
Unknown Facility
Memphis, Tennessee, 38103, United States
Unknown Facility
Temple, Texas, 76508, United States
Unknown Facility
Salt Lake City, Utah, 84113, United States
Unknown Facility
Burlington, Vermont, 05401, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
Unknown Facility
Richmond, Virginia, 23219, United States
Unknown Facility
Huntington, West Virginia, 25701, United States
Unknown Facility
Morgantown, West Virginia, 26506, United States
Unknown Facility
Madison, Wisconsin, 53715, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- U. S. Contact Center
- Organization
- Wyeth
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
Study Record Dates
First Submitted
August 16, 2006
First Posted
August 17, 2006
Study Start
September 1, 2006
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
May 4, 2010
Results First Posted
January 7, 2010
Record last verified: 2010-04