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Sponsored by: |
Eisai Medical Research Inc. |
Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00658528 |
This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, RAB ER 50 mg or ESO 40 mg for the treatment of moderate to severe erosive GERD.
Condition | Intervention | Phase |
Gastroesophageal Reflux Disease (GERD) |
Drug: Rabeprazole sodium Drug: Esomeprazole |
Phase III |
MedlinePlus related topics: | GERD |
ChemIDplus related topics: | Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium E 3810 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD) |
Estimated Enrollment: | 1060 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: Rabeprazole sodium
Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks.
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2: Active Comparator |
Drug: Esomeprazole
Esomeprazole 40 mg capsule, once daily for 4-8 weeks.
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
KEY INCLUSION CRITERIA:
KEY EXCLUSION CRITERIA:
Current or a history of cancer, with the exception of fully excised skin basal cell carcinoma.
Contact: Eisai Medical Research Inc. | 1-201-403-2500 |
United States, California | |||||
Advanced Clinical Research Institute | Recruiting | ||||
Anaheim, California, United States, 92801 |
Eisai Medical Research Inc. |
Study Director: | Yufang Lu, MD, PhD | Eisai Medical Research Inc. |
Responsible Party: | Eisai Medical Research Inc. ( Yufang Lu, Study Director ) |
Study ID Numbers: | E3810-G000-301 |
First Received: | April 9, 2008 |
Last Updated: | April 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00658528 |
Health Authority: | United States: Food and Drug Administration |
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