Maintenance Intermittent Therapy for Symptomatic GERD Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2008-06-30

Brief Summary

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The purpose of this study to determine the efficacy of 20 mg of rabeprazole given as a maintenance intermittent therapy following acute treatment for Symptomatic Gastroesophageal Reflux Disease (s-GERD).

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Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Rabeprazole 20 mg

Intervention Type DRUG

rabeprazole sodium tablet 20 mg once daily

Rabeprazole 20 mg

Group Type EXPERIMENTAL

Rabeprazole 20 mg

Intervention Type DRUG

rabeprazole sodium tablet 20 mg once daily

Interventions

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Rabeprazole 20 mg

rabeprazole sodium tablet 20 mg once daily

Intervention Type DRUG

Other Intervention Names

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rabeprazole

Eligibility Criteria

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Inclusion Criteria

1. Male or female patients, 18 to 65 years of age.
2. If female, not of childbearing potential by reason of surgery, radiation or menopause, or of childbearing potential, but using an approved method of contraception since the last menstrual period, for example, intrauterine device (IUD), implant, double barrier method, or oral contraceptives for at least one cycle. Females of childbearing potential must have a negative urine pregnancy test before medication is dispensed.
3. Patients must report a minimum three-month history of GERD symptoms. GERD symptoms are defined as heartburn with or without regurgitation or other associated GERD symptoms.
4. Patients must have at least 4 days with heartburn per week in each of the 2 weeks prior to Screening.
5. Patients must have no esophagitis, with no proton pump inhibitors (PPIs, prescription or OTC), H2 blockers (prescription or OTC) or prokinetics within 14 days, prior to the endoscopy.

Exclusion Criteria

1. Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric or cardiovascular system abnormalities, unless the Sponsor and Investigator agree that the nature and severity of any abnormality is unlikely to interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.
2. Females must not be pregnant, lactating or have a positive urine eta human chorionic gonadotropin (B-hCG) laboratory result.
3. Patients with a history of allergy or sensitivity to proton pump inhibitors or to their inactive ingredients.
4. Patients with known gastric ulcer, duodenal ulcer, infectious or inflammatory conditions of the small or large intestine, malabsorption syndromes, obstruction, a history of gastrointestinal malignancy, or prior gastric or intestinal surgery (including vagotomy).
5. Patients who have a history of Barrett's esophagus, esophageal stricture, or pyloric stenosis.
6. Patients with a history of endoscopically-proven esophagitis any time in the past.
7. Patients who have taken proton pump inhibitors (PPIs, prescription or OTC), H2 blockers (prescription or OTC) or prokinetics within 14 days, prior to Screening endoscopy, or any of these medications within 7 days prior to the single-blind placebo run-in period.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No