Trials / Completed
CompletedNCT00373334
Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)
A Double-Blind, Randomized, Parallel, Multicenter Study of Axid (Nizatidine) Oral Solution in the Treatment of Gastroesophageal Reflux Disease (GERD) Symptoms in Infants Age 30 Days-1 Year
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 138 (actual)
- Sponsor
- Braintree Laboratories · Industry
- Sex
- All
- Age
- 30 Days – 1 Year
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | nizatidine (axid) | nizatidine (axid) |
| DRUG | nizatidine (axid) | nizatidine (axid) |
| DRUG | placebo | placebo |
Timeline
- Start date
- 2006-08-01
- Primary completion
- 2008-02-01
- Completion
- 2008-02-01
- First posted
- 2006-09-08
- Last updated
- 2009-11-18
- Results posted
- 2009-11-17
Locations
26 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00373334. Inclusion in this directory is not an endorsement.