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

NCT00236184 | Completed Phase 3 Results DMC

• 1 other identifier: E3810-A001-313
• Study Type: interventional
• Target: 629
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heartburn

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population

  14-day treatment period.

• Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population

  14-day treatment period.

• Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole.

  14-day treatment period.

• Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole.

  14-day treatment period.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Oral placebo tablet

Other: Placebo

Rabeprazole sodium 10 mg

EXPERIMENTAL

oral rabeprazole 10 mg enteric-coated tablet

Drug: rabeprazole sodium

Interventions

rabeprazole sodium DRUG

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.

Also known as: Aciphex

Rabeprazole sodium 10 mg

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Jeffrey L. Newman

Vista, California, 92084, United States

Location

MeSH Terms

Conditions

Heartburn

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Yufang Lu, MD, PhD, Study Director
• Organization: Eisai Medical Research Inc.

201-403-2500

Study Officials

• Yufang Lu, MD, PhD

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 10, 2005
• First Posted: October 12, 2005
• Study Start: October 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: June 1, 2008
• Last Updated: April 6, 2010
• Results First Posted: October 1, 2009

Record last verified: 2010-03

Locations

US (1)