Maintenance Intermittent Therapy for Symptomatic GERD Patients

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00165841
First received: September 13, 2005
Last updated: May 13, 2013
Last verified: December 2009
  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 2

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


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 ]
    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.


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 percentage of heartburn-free daytime period is presented cumulatively including all data collected during the 6-month Maintenance Phase

  • 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 ]
    The percentage of heartburn-free nighttime period is presented cumulatively including all data collected during the 6-month


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 Comparator: Placebo Drug: Rabeprazole 20 mg
rabeprazole sodium tablet 20 mg once daily
Other Name: rabeprazole
Experimental: Rabeprazole 20 mg Drug: Rabeprazole 20 mg
rabeprazole sodium tablet 20 mg once daily
Other Name: rabeprazole

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Eisai Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yufang Lu, Study Director, Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00165841     History of Changes
Other Study ID Numbers: E3810-A001-203
Study First Received: September 13, 2005
Results First Received: August 18, 2009
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
non-erosive symptomatic GERD
GERD

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014