Trials / Terminated
TerminatedNCT04821310
Protonix Treatment of Maintenance of Healing in Pediatric Participants Aged 1-11 Years and 12-17 Years
AN EXPLORATORY, MULTICENTER, RANDOMIZED, DOUBLE BLIND STUDY OF CLINICAL OUTCOMES, TOLERABILITY, AND SAFETY OF 2 DOSES OF ORAL PANTOPRAZOLE IN PEDIATRIC PARTICIPANTS AGED 1 TO 11 YEARS AND 12 TO 17 YEARS WHO REQUIRE MAINTENANCE THERAPY FOR HEALED EROSIVE ESOPHAGITIS
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 1 Year – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.
Detailed description
Explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Full dose Pantoprazole plus matching placebo | Full healing dose of pantoprazole plus matching placebo |
| DRUG | Half Dose Pantoprazole plus matching placebo | Half healing dose of pantoprazole plus matching placebo |
Timeline
- Start date
- 2022-01-13
- Primary completion
- 2025-12-16
- Completion
- 2025-12-16
- First posted
- 2021-03-29
- Last updated
- 2026-04-13
Locations
28 sites across 9 countries: United States, Bosnia and Herzegovina, Georgia, India, Puerto Rico, Serbia, Slovakia, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04821310. Inclusion in this directory is not an endorsement.