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

Sponsored by:	Eisai Medical Research Inc.
Information provided by:	Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00236184

Purpose

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.

Condition	Intervention	Phase
Heartburn	Drug: Rabeprazole sodium	Phase III

MedlinePlus related topics: Heartburn

Drug Information available for: E 3810

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety Study
Official Title:	E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:

All efficacy assessments will be derived from data recorded in the patients' daily diaries. Patients will record the incidence and severity of their heartburn, symptoms of regurgitation, belching, bloating and antacid consumption. [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse event monitoring will assess safety. [ Designated as safety issue: Yes ]

Enrollment:	629
Study Start Date:	October 2005
Study Completion Date:	June 2008
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both

Criteria

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.
Heartburn must have responded in the past to some degree to antacids or over the counter H2 receptor antagonist treatment.
Patients need to be able to provide written informed consent and able and willing to complete a daily diary and return for all study visits.

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.
Females who are pregnant or lactating.
Patients with a known or suspected history of alcohol or drug misuse within five years.
Patients who have participated in another investigational drug study within 30 days prior to screening or are expected to receive an investigational drug during this trial.
Patients with a history of allergy or sensitivity to proton pump inhibitors and/or Gelusil® or to their inactive ingredients.
Patients with malignancy or treatment for malignancy within the year prior to study entry, except simple excision of basal cell carcinoma.
Patients with clinically relevant abnormal laboratory tests at the initial visit.
Patients who require continuous use of PPIs, 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.
Patients who are receiving warfarin.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236184

Locations

United States, California
Jeffrey L. Newman
Vista, California, United States, 92084

Sponsors and Collaborators

Eisai Medical Research Inc.

Investigators

Study Director:

Claudio Pasquinelli

Eisai Medical Research Inc.

More Information

Study ID Numbers:	E3810-A001-313
Study First Received:	October 10, 2005
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00236184
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Pyrosis
Signs and Symptoms, Digestive
Heartburn
Rabeprazole

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009