Trials / Completed
CompletedNCT00132496
Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients With Rabeprazole
Safety and Efficacy of Rabeprazole in the Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 111 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 12 Years – 16 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to collect safety information on rabeprazole 10 mg and 20 mg in the treatment of gastroesophageal reflux disease (GERD) in children aged 12 to 16 years. The secondary objectives are to assess the efficacy of rabeprazole on the improvement of the symptoms of GERD and to explore the relationship of symptom relief to dose received, based on symptom frequency and severity, antacid use, and quality of life (QOL) measures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rabeprazole sodium | administered orally and once daily to patients randomized to receive either 10 mg or 20 mg. |
Timeline
- Start date
- 2005-08-01
- Primary completion
- 2006-05-01
- Completion
- 2006-07-01
- First posted
- 2005-08-22
- Last updated
- 2009-12-03
- Results posted
- 2009-12-03
Locations
25 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00132496. Inclusion in this directory is not an endorsement.