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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 is a Phase 3 study that has completed, run by Braintree Laboratories. The registered enrollment target is 138 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00373334
The ClinicalTrials.gov registry entry for NCT00373334 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Braintree Laboratories, which has 49 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00373334 reports 0 study locations.
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.
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