Open Label Study Evaluating Different Dosing Regimens of Rabeprazole in Gastro-esophageal Reflux Disease (GERD) Patients With Night-time Heartburn Symptoms.
|ClinicalTrials.gov Identifier: NCT00553449|
Recruitment Status : Completed
First Posted : November 5, 2007
Last Update Posted : May 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Heartburn||Drug: rabeprazole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised, Controlled, Parallel-group, Open-label Study to Evaluate Different Dosing Regimens of Rabeprazole in Controlling Nocturnal Heartburn Symptoms in Patients With Gastroesophageal Reflux Disease.|
|Study Start Date :||July 2004|
|Study Completion Date :||September 2005|
- The primary analysis will be based on the mean nocturnal heartburn score observed after four weeks of drug administration for each of the three dosing regimens of rabeprazole.
- Nocturnal heartburn score at end of treatment/ 8 weeks; HRQoL and productivity outcomes 4 & 8 wks; rescue meds usage & compliance with study meds over entire study; day-time heartburn score 4 & 8 wks.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553449
|Study Director:||Janssen-Ortho Inc. Clinical Trial||Janssen-Ortho Inc., Canada|