Maintenance Intermittent Therapy for Symptomatic GERD Patients - Full Text View

Sponsor:	Eisai Inc.
Information provided by:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00165841

Purpose

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).

Condition	Intervention	Phase
Gastroesophageal Reflux Disease	Drug: Rabeprazole 20 mg	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: GERD Heartburn

Drug Information available for: E 3810

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

The Percentage of Heartburn-free Days (24-hour Periods) During the 6-month Maintenance Treatment Phase (ITT Population). [ Time Frame: 6 months double-blind maintenance phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The Percent of Heartburn-free Daytime Period During the 6-month Maintenance Treatment Phase [ Time Frame: 6-month maintenance phase ] [ Designated as safety issue: No ]
The Percent of Heartburn-free Nighttime Period During the 6-month Maintenance Treatment Phase [ Time Frame: 6-month maintenance phase ] [ Designated as safety issue: No ]

Enrollment:	200
Study Start Date:	October 2004
Study Completion Date:	June 2008
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	Drug: Rabeprazole 20 mg rabeprazole sodium tablet 20 mg once daily
Rabeprazole 20 mg: Experimental	Drug: Rabeprazole 20 mg rabeprazole sodium tablet 20 mg once daily

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165841

Locations

United States, California
Quality Care Medical Center Inc.
Vista, California, United States, 92085

Sponsors and Collaborators

Eisai Inc.

Investigators

Study Director:

Yufang Lu

Eisai Inc.

More Information

No publications provided

Responsible Party:	Eisai Medical Research Inc. ( Yufang Lu, Study Director )
Study ID Numbers:	E3810-A001-203
Study First Received:	September 13, 2005
Results First Received:	August 18, 2009
Last Updated:	December 30, 2009
ClinicalTrials.gov Identifier:	NCT00165841 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eisai Inc.:

non-erosive symptomatic GERD
GERD

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions
Esophageal Motility Disorders

Deglutition Disorders
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases
Rabeprazole

ClinicalTrials.gov processed this record on February 08, 2010