E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers

Heartburn Clinical Trial

Official title:

E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00236184
• Other study ID #: E3810-A001-313
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2005
• Last updated: March 30, 2010
• Start date: October 2005
• Est. completion date: June 2008

Study information

• Verified date: March 2010
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 629
• Est. completion date: June 2008
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heartburn

Intervention

Drug:
• rabeprazole sodium
Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.

Other:
• Placebo
Following a one week single-blind, placebo run-in phase, patients will receive placebo orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.

Locations

Country	Name	City	State
United States	Jeffrey L. Newman	Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population.	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.	first 24 hours	No
Secondary	Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population	comparison between placebo and treatment will be analyzed using two-sample t-test.	14-day treatment period.	No
Secondary	Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population	comparison between placebo and treatment will be analyzed using two-sample t-test.	14-day treatment period.	No
Secondary	Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole.	comparison between placebo and treatment will be analyzed using two-sample t-test.	14-day treatment period.	No
Secondary	Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole.	comparison between placebo and treatment will be analyzed using two-sample t-test.	14-day treatment period.	No