Status:
COMPLETED
E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
Lead Sponsor:
Eisai Inc.
Conditions:
Heartburn
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn.
Detailed Description
This is a multicenter, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. The study will last for up to five...
Eligibility Criteria
Inclusion
- Key
- Male or female patients \> 18 years of age.
- If female, not of childbearing potential by reason of surgery or menopause, or of childbearing potential, but using an approved method of contraception since the last menstrual period. Females of childbearing potential must have a negative serum pregnancy test before starting the study.
- Patients must report a history of heartburn at least two days per week over the past month.
- Key
Exclusion
- History of erosive esophagitis verified by endoscopy.
- History of gastroesophageal reflux disease (GERD) diagnosed by a physician.
- Patients who have a history of Barrett's esophagus or esophageal stricture.
- Evidence of any medical condition that may interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.
- Patients who require continuous use of proton pump inhibitors, histamine receptor (H2) blockers, or prokinetics. Prior intermittent use of these agents is permitted if they are discontinued at least three days prior to the run-in phase. The H2 blocker, cimetidine (Tagamet®), must be discontinued for at least seven days before the study drug is administered.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
619 Patients enrolled
Trial Details
Trial ID
NCT00236197
Start Date
October 1 2005
End Date
June 1 2008
Last Update
November 11 2009
Active Locations (1)
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1
New York Center For Clinical Research
Lake Success, New York, United States, 11042