Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
Tracking Information
tart Date ICMJE | February 2008 |
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Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: April 14, 2008) | Upper GI endoscopy (EGD), symptoms based on subject's daily diary and investigator's assessment. [ Time Frame: Every 4-8 weeks. ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00658528 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: November 17, 2008) | Adverse events, electrocardiograms (ECGs), laboratory evaluations (hematology, blood chemistry, urinalysis, serum gastrin), physical examinations, vital signs. [ Time Frame: Every 4-8 weeks. ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE (submitted: April 14, 2008) | Adverse events, ECGs, laboratory evaluations (hematology, blood chemistry, urinalysis, serum gastrin), physical examinations, vital signs. [ Time Frame: Every 4-8 weeks. ] [ Designated as safety issue: Yes ] |
Descriptive Information
Brief Title ICMJE | Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD) |
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Official Title ICMJE | 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) |
Brief Summary | The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (GERD). |
Detailed Description | This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all of 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. |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Gastroesophageal Reflux Disease (GERD) |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 1060 | ||||
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Completion Date | |||||
Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | KEY INCLUSION CRITERIA:
KEY EXCLUSION CRITERIA:
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Gender | Both | ||||
Ages | 18 Years to 75 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Bulgaria, Canada, Chile, Croatia, Estonia, France, Germany, Hungary, India, Latvia, Lithuania, Mexico, New Zealand, Poland, Russian Federation, Serbia, Slovakia, South Africa, Ukraine |
Administrative Information
NCT ID ICMJE | NCT00658528 | ||||
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Responsible Party | Yufang Lu, Study Director, Eisai Medical Research Inc. | ||||
Study ID Numbers ICMJE | E3810-G000-301 | ||||
Study Sponsor ICMJE | Eisai Inc. | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Eisai Inc. |
Source: http://clinicaltrials.gov/