Open Label Study Evaluating Different Dosing Regimens of Rabeprazole in Gastro-esophageal Reflux Disease (GERD) Patients With Night-time Heartburn Symptoms.
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|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|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553449
|Study Director:||Janssen-Ortho Inc. Clinical Trial||Janssen-Ortho Inc., Canada|