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NCT00373334 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)
A Phase 3 study, sponsored by Braintree Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 138
- Enrollment target
NCT00373334: Completed Phase 3 study, sponsored by Braintree Laboratories.
NCT00373334 is a Phase 3 study that has completed, run by Braintree Laboratories. The registered enrollment target is 138 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00373334, a Phase 3 study, has completed, sponsored by Braintree Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 138 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the efficacy, acceptability, and safety of Axid Oral Solution versus placebo in the treatment of gastroesophageal reflux disease (GERD) in infants age 30 days up to 1 year.
Primary Outcome
The I-GERQ-R contains 12 questions assessing gastroesophageal reflux disease (GERD) frequency and severity. A low I-GERQ-R score (minimum = 0) indicates minimal symptoms and a high I-GERQ-R score (maximum = 42) indicates more frequent and/or severe symptoms. Success is defined as a reduction in I-GERQ-R score of at least 5 points from baseline, provided a subject did not discontinue due to lack of efficacy or adverse event, and had been treated for at least 4 weeks.
Interventions
- DRUG placebo
- DRUG nizatidine (axid)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2006-08 |
| Est. Completion | 2008-02 |
| Phase | Phase 3 |
What the finished NCT00373334 record still lists
NCT00373334 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00373334 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00373334 about?
NCT00373334 is a clinical study titled "Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)". The objective of this study is to evaluate the efficacy, acceptability, and safety of Axid Oral Solution versus placebo in the treatment of gastroesophageal reflux disease (GERD) in infants age 30 days up to 1 year.
What is the current status of trial NCT00373334?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 138 participants. The study started on 2006-08. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00373334?
The interventions under investigation include: placebo (DRUG), nizatidine (axid) (DRUG).
Who is sponsoring clinical trial NCT00373334?
This trial is sponsored by Braintree Laboratories, which has 49 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00373334's enrollment target sits among peer trials
138 1577th of 2000 higher than 421 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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