Maintenance Intermittent Therapy for Symptomatic GERD Patients

NCT00165841 | Completed Phase 2 Results

• 1 other identifier: E3810-A001-203
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Gastroesophageal Reflux Disease

Keywords

non-erosive symptomatic GERD; GERD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• The Percent of Heartburn-free Daytime Period During the 6-month Maintenance Treatment Phase

  6-month maintenance phase

• The Percent of Heartburn-free Nighttime Period During the 6-month Maintenance Treatment Phase

  6-month maintenance phase

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Rabeprazole 20 mg

Rabeprazole 20 mg

EXPERIMENTAL

Drug: Rabeprazole 20 mg

Interventions

Rabeprazole 20 mg DRUG

rabeprazole sodium tablet 20 mg once daily

Also known as: rabeprazole

Placebo; Rabeprazole 20 mg

Eligibility Criteria

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

You may qualify if:

• Male or female patients, 18 to 65 years of age.
• 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.
• 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.
• Patients must have at least 4 days with heartburn per week in each of the 2 weeks prior to Screening.
• 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.

You may not qualify if:

• 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.
• Females must not be pregnant, lactating or have a positive urine eta human chorionic gonadotropin (B-hCG) laboratory result.
• Patients with a history of allergy or sensitivity to proton pump inhibitors or to their inactive ingredients.
• 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).
• Patients who have a history of Barrett's esophagus, esophageal stricture, or pyloric stenosis.
• Patients with a history of endoscopically-proven esophagitis any time in the past.
• 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Quality Care Medical Center Inc.

Vista, California, 92085, United States

Location

Related Publications (1)

• Fass R, Delemos B, Nazareno L, Kao R, Xiang J, Lu Y. Clinical trial: maintenance intermittent therapy with rabeprazole 20 mg in patients with symptomatic gastro-oesophageal reflux disease - a double-blind, placebo-controlled, randomized study. Aliment Pharmacol Ther. 2010 May;31(9):950-60. doi: 10.1111/j.1365-2036.2010.04254.x. Epub 2010 Feb 2.

  PMID: 20132154 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

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, Study Director
• Organization: Eisai Medical Research Inc.

201-403-2500

Study Officials

• Yufang Lu

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 14, 2005
• Study Start: October 1, 2004
• Primary Completion: December 1, 2005
• Study Completion: June 1, 2008
• Last Updated: May 20, 2013
• Results First Posted: December 3, 2009

Record last verified: 2009-12

Locations

US (1)