E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
- Registration Number
- NCT00236184
- Lead Sponsor
- Eisai Inc.
- Brief Summary
The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 629
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Oral placebo tablet Rabeprazole sodium 10 mg rabeprazole sodium oral rabeprazole 10 mg enteric-coated tablet
- Primary Outcome Measures
Name Time Method Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population. first 24 hours Subject was considered "complete relief" if he/she did not heartburn during the nighttime of the first dose date and no heartburn during the daytime of 1 day after the first dose date. The difference in complete relief within the first 24 hours between treatment groups was tested using a continuity corrected chi-square test without adjustment baseline heartburn severity.
- Secondary Outcome Measures
Name Time Method Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population 14-day treatment period. comparison between placebo and treatment will be analyzed using two-sample t-test.
Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population 14-day treatment period. comparison between placebo and treatment will be analyzed using two-sample t-test.
Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole. 14-day treatment period. comparison between placebo and treatment will be analyzed using two-sample t-test.
Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole. 14-day treatment period. comparison between placebo and treatment will be analyzed using two-sample t-test.
Trial Locations
- Locations (1)
Jeffrey L. Newman
🇺🇸Vista, California, United States