Clinical trial NCT00236184: E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
Official title: E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heartburn
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 629
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients \> 18 years of age.
2. 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.
3. Patients must report a history of heartburn at least two days per week over the past month.

Exclusion Criteria:

1. History of erosive esophagitis verified by endoscopy.
2. History of gastroesophageal reflux disease (GERD) diagnosed by a physician.
3. Patients who have a history of Barrett's esophagus or esophageal stricture.
4. 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.
5. 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.

Primary outcomes:
measure: Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population.
timeFrame: first 24 hours
Secondary outcomes:
measure: Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population
timeFrame: 14-day treatment period.
measure: Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population
timeFrame: 14-day treatment period.
measure: Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole.
timeFrame: 14-day treatment period.
measure: Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole.
timeFrame: 14-day treatment period.
Other outcomes:
Locations:
city: Vista
country: United States
facility: Jeffrey L. Newman
state: California
Study officials:
affiliation: Eisai Inc.
name: Yufang Lu, MD, PhD
role: STUDY_DIRECTOR
References: