NCT00365300CompletedPhase 3
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.
Wyeth is now a wholly owned subsidiary of Pfizer0 sites129 target enrollmentStarted: September 2006Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 129
- Primary Endpoint
- Number of Patients Withdrawn From Study Due to Lack of Efficacy.
Study Overview
Brief Summary
To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 28 Days to 11 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •known history of upper GI anatomic disorders
- •history of acute life-threatening medical conditions
- •clinically significant medical conditions or laboratory abnormalities
Arms & Interventions
Pantoprazole
Active Comparator
Intervention: pantoprazole (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Patients Withdrawn From Study Due to Lack of Efficacy.
Time Frame: 4 weeks double-blind
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
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