Maintenance Intermittent Therapy for Symptomatic GERD Patients

Gastroesophageal Reflux Disease Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled Study of Rabeprazole 20 mg Maintenance Intermittent Therapy Following Acute Treatment in Patients Wth Symptomatic Gastroesophageal Reflux Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165841
• Other study ID #: E3810-A001-203
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: May 13, 2013
• Start date: October 2004
• Est. completion date: June 2008

Study information

• Verified date: December 2009
• 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2008
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Key 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.

Key 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Rabeprazole 20 mg
rabeprazole sodium tablet 20 mg once daily

Locations

Country	Name	City	State
United States	Quality Care Medical Center Inc.	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	The Percentage of Heartburn-free Days (24-hour Periods) During the 6-month Maintenance Treatment Phase (ITT Population).	The percentage of heartburn-free days during the 6-month Maintenance Treatment Phase in patients treated with rabeprazole 20 mg compared to patients who received placebo in the ITT Population. Heartburn-free day was defined as no heartburn in both the daytime and nighttime period on a given day. Note a total 388 subjects were enrolled at the beginning of Acute Phase and 200 subjects were enrolled into the double-blind 6-month maintenance treatment phase.	6 months double-blind maintenance phase	No
Secondary	The Percent of Heartburn-free Daytime Period During the 6-month Maintenance Treatment Phase	The percentage of heartburn-free daytime period is presented cumulatively including all data collected during the 6-month Maintenance Phase	6-month maintenance phase	No
Secondary	The Percent of Heartburn-free Nighttime Period During the 6-month Maintenance Treatment Phase	The percentage of heartburn-free nighttime period is presented cumulatively including all data collected during the 6-month	6-month maintenance phase	No