Phase 3
N=129
Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
Gastroesophageal Reflux
Bottom Line
View on ClinicalTrials.gov: NCT00365300 ↗Enrolled (actual)
129
Serious AEs
2.0%
Results posted
Jan 2010
Primary outcome: Primary: Number of Patients Withdrawn From Study Due to Lack of Efficacy. — 6; 6 patients — p=1.0
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pantoprazole (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Withdrawn From Study Due to Lack of Efficacy. |
6; 6 | 1.0 |
Summary
To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00365300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.