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NCT00868296 · ClinicalTrials.gov registry record · Phase 3
Open Label Safety Study of Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed Gastroesophageal Reflux Disease (GERD)
A Phase 3 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 58
- Enrollment target
NCT00868296: Completed Phase 3 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
NCT00868296 is a Phase 3 study that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 58 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00868296, a Phase 3 study, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 58 participants
- Enrollment target
Study Summary
The purpose of this study is to provide additional information on safety and tolerability after multiple does of pantoprazole. Only patients who successfully completed the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) are eligible to participate in this study.
Primary Outcome
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Criteria are as follows: Potassium ≤ 3.0 mEq/L or ≥ 6.2 mEq/L; Carbon dioxide \< 12 mEq/L or \> 35 mEq/L; Total bilirubin \> 1.5xULN; CPK \> 3xULN; Gastrin ≥ 600 pg/mL; Neutrophils \< 10% or \> 80%; Platelet count \< 100 x10 to the third power/ul or \> 600 x10 to the third power/ul; Urine protein albumin \> 2+ (dipstick) 100mg/dL or positive; Urine leu
Interventions
- DRUG pantoprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2006-03 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
What the finished NCT00868296 record still lists
NCT00868296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which pantoprazole is the first listed.
NCT00868296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00868296 about?
NCT00868296 is a clinical study titled "Open Label Safety Study of Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed Gastroesophageal Reflux Disease (GERD)". The purpose of this study is to provide additional information on safety and tolerability after multiple does of pantoprazole. Only patients who successfully completed the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) are eligible to participate in this study.
What is the current status of trial NCT00868296?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 58 participants. The study started on 2006-03. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00868296?
The interventions under investigation include: pantoprazole (DRUG).
Who is sponsoring clinical trial NCT00868296?
This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00868296's enrollment target sits among peer trials
58 1825th of 2000 higher than 174 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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