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Rabeprazole 20 mg Maintenance Intermittent Therapy Following Acute Treatment in Patients With Symptomatic Gastroesophageal Reflux Disease
This study has been completed.
First Received: September 13, 2005   Last Updated: July 17, 2008   History of Changes
Sponsored by: Eisai Medical Research Inc.
Information provided by: Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00165841
  Purpose

This is a 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 Sodium
Phase II

MedlinePlus related topics: GERD
Drug Information available for: E 3810
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study
Official Title: A Double-Blind, Placebo-Controlled Study of Rabeprazole 20 mg Maintenance Intermittent Therapy Following Acute Treatment in Patients With Symptomatic Gastroesophageal Reflux Disease

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:
  • The percentage of heartburn-free days in patients with symptomatic gastroesophageal reflux disease (s-GERD) who are receiving maintenance intermittent therapy with 20 mg of rabeprazole compared to patients who are receiving placebo. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare 20 mg of rabeprazole with placebo in regard to symptom frequency, severity, and several other related measures. [ Designated as safety issue: No ]

Estimated Enrollment: 340
Study Start Date: October 2004
Study Completion Date: June 2008
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  Eligibility

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

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, 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 a no esophagitis (that is, no macroscopic erosions) on endoscopy at Screening (Grade 0 or 1 modified Hetzel-Dent), with no proton pump inhibitors (PPIs, prescription or OTC), H2 blockers (prescription or OTC) or prokinetics within 14 days, prior to the endoscopy.
  6. Patients with a history of appendectomy or cholecystectomy are eligible.
  7. Patients must be able to read, write and understand the language of the QOL assessment instruments (GSAS, PAGI-QOL).

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 B-hCG laboratory result.
  3. Patients with a known or suspected history of alcohol or drug misuse within 5 years.
  4. Patients who are unwilling or unable to abide by the requirements of the study or who violate the prohibitions and restrictions of the study.
  5. Any condition which would make the patient, in the opinion of the Investigator or Sponsor, unsuitable for the study.
  6. Patients who have participated in another investigational drug study within 30 days prior to screening or are expected to receive an investigational drug during this trial.
  7. Patients with a history of allergy or sensitivity to proton pump inhibitors or to their inactive ingredients.
  8. Patients who are unable or unwilling to give informed consent.
  9. Patients who are unable or unwilling to complete a daily diary.
  10. Patients who are unable or unwilling to return for all required study visits.
  11. 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).
  12. Patients who have a history of Barrett's esophagus, esophageal stricture, or pyloric stenosis.
  13. Patients with a history of endoscopically-proven esophagitis (Grade 2 or more, modified Hetzel-Dent, or equivalent) any time in the past.
  14. Patients with scleroderma.
  15. Patients with malignancy or treatment for malignancy within the year prior to study entry, except simple excision of basal cell carcinoma.
  16. Patients who are known to be HIV positive.
  17. Patients with clinically relevant abnormal laboratory tests at the initial visit, including liver enzymes greater than two times the upper limit of normal.
  18. 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.
  19. Patients who are unable to discontinue the use of anticholinergics, cholinergics, spasmolytics, opiates and/or sucralfate.
  20. Patients who require daily use of NSAIDs (non-steroidal antiinflammatory drugs), oral steroids (20 mg/day prednisone or equivalent) or aspirin (> 325 mg/day).
  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
Sponsors and Collaborators
Eisai Medical Research Inc.
Investigators
Study Director: Yufang Lu Eisai Medical Research Inc.
  More Information

No publications provided

Study ID Numbers: E3810-A001-203
Study First Received: September 13, 2005
Last Updated: July 17, 2008
ClinicalTrials.gov Identifier: NCT00165841     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal Disorder
Gastrointestinal Diseases
Esophageal Diseases
Gastroesophageal Reflux
Rabeprazole

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 May 06, 2009