Phase 3 N=619 Randomized Double-blind Treatment

E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers

Heartburn

Bottom Line

View on ClinicalTrials.gov: NCT00236197 ↗

Enrolled (actual)

619

Serious AEs

0.0%

Results posted

Nov 2009

Primary outcome: Primary: Complete Heartburn Relief During the First Full 24-Hour Period in Intent-to-Treat (ITT) Population — 100; 121 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: rabeprazole sodium (Drug); placebo (Drug)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Eisai Inc.
Primary completion: Mar 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Complete Heartburn Relief During the First Full 24-Hour Period in Intent-to-Treat (ITT) Population	100; 121	—
SECONDARY Summary of Percentage of Heartburn-Free Daytimes	—	—
SECONDARY Summary of Percentage of Heartburn-Free Nighttimes	—	—
SECONDARY Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole	—	—
SECONDARY Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole	—	—

Summary

The purpose of this study is to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn.

Eligibility Criteria

Key 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.

Key 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00236197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.