E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10 mg in treating frequent heartburn.
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 weeks and consists of the following three phases: a one to two week screening period that includes a one-week, single-blind, placebo run-in phase, a two week double-blind, randomized treatment phase, and a one week single-blind, placebo follow-up phase.
Status: Completed (Phase 3). Started on October 1st, 2005.
Enrollment: 629 subjects
Study Type: Interventional
Study Design:
- Allocation: Randomized
- Endpoint Classification: Safety/Efficacy Study
- Intervention Model: Parallel Assignment
- Masking: Double Blind (Subject
- Investigator)
- Primary Purpose: Treatment
Conditions:
Interventions:
- Drug: rabeprazole sodium (Aciphex)
- Other: Placebo
Eligibility
Inclusion Criteria:
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.
Exclusion Criteria:
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.
- Gender
Both
- Mininum Age
19 Years
- Maximum Age
N/A
- Healthy Volunteers
No
Resources
Source: Eisai Inc.
Authority: United States: Food and Drug Administration
Locations
-
Jeffrey L. Newman
Vista
California
92084
United States
Officials
Yufang Lu, MD, PhD (Study Director, Eisai Inc.)
Sponsors
Eisai Inc. (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- March 1st, 2010
- First Received
- March 30th, 2010
- Last Changed
- March 30th, 2010
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
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