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

Condition(s) targeted: Heartburn

Intervention: RABEPRAZOLE SODIUM (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Eisai Medical Research Inc.

Official(s) and/or principal investigator(s):
Claudio Pasquinelli, Study Director, Affiliation: Eisai Medical Research Inc.

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.

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study

Primary outcome:

The difference in complete relief within the first 24 hours between treatment and placebo will

be tested using a continuity corrected chi-square test. The primary analysis will be on ITT

population.

Secondary outcome:

There are four secondary outcomes:

reduction of daytime heartburn,

reduction of nighttime heartburn,

the change from baseline in average regurgitation scores, and

the change from baseline in average belching scores, compared with placebo over a 14-day

treatment period.

Tertiary Outcomes:

Reduction in average severity of bloating

Reduction of antacid consumption

Safety

All tested over 14 days using Bonfenoni step-down procedure.

Minimum age: 19 Years. Maximum age: N/A. Gender(s): 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.

New York Center For Clinical Research, Lake Success, New York 11042, United States

Starting date: October 2005
Last updated: May 17, 2006