Phase 3
N=60
Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
Gastroesophageal Reflux
Bottom Line
View on ClinicalTrials.gov: NCT00300755 ↗Enrolled (actual)
60
Serious AEs
—
Results posted
May 2010
Primary outcome: Primary: Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) — -0.89; 0.02; -0.47; -1.11 units on scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pantoprazole sodium enteric-coated spheroid (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) |
-0.89; 0.02; -0.47; -1.11; -0.11; -1.24 | <0.001 sig |
| SECONDARY Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week |
-0.77; -0.06; -0.25; -0.43; -0.05; -0.47 | 0.002 sig |
| SECONDARY Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline |
0.11; 0.13; 0.11; -0.38; -0.20; -0.24 | 0.004 sig |
| SECONDARY Number of Patients With "Healed" Erosive Esophagitis (EE) at End of Study |
0; 2; 2 | — |
Summary
To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.
Eligibility Criteria
Inclusion Criteria
- Ability to undergo endoscopy with required biopsy
- Ages 1 through 5 years
- Endoscopically confirmed GERD by positive endoscopic evidence of reflux related esophagitis or positive histologic evidence of esophagitis consistent with GERD Other inclusions apply.
Exclusion Criteria
- History or presence of upper gastrointestinal anatomic or motor disorders
- Known current or active cow's milk allergy
- Malignancy
- Other exclusions apply.
Data sourced from ClinicalTrials.gov (NCT00300755). 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.