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Maintenance Intermittent Therapy for Symptomatic GERD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00165841
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : December 3, 2009
Last Update Posted : May 20, 2013
Sponsor:
Information provided by:
Eisai Inc.

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 14, 2005
Results First Submitted Date  ICMJE August 18, 2009
Results First Posted Date  ICMJE December 3, 2009
Last Update Posted Date May 20, 2013
Study Start Date  ICMJE October 2004
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2009)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Patient diaries and symptom assessments. The secondary efficacy objectives will be assessed by patient diaries, self assessment questionnaires, and endoscopy.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2009)
  • The Percent of Heartburn-free Daytime Period During the 6-month Maintenance Treatment Phase [ Time Frame: 6-month maintenance phase ]
    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 ]
    The percentage of heartburn-free nighttime period is presented cumulatively including all data collected during the 6-month
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Safety will be evaluated by monitoring adverse events, vital signs, physical examination and clinical laboratory values.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Maintenance Intermittent Therapy for Symptomatic GERD Patients
Official Title  ICMJE A Double-Blind, Placebo-Controlled Study of Rabeprazole 20 mg Maintenance Intermittent Therapy Following Acute Treatment in Patients Wth Symptomatic Gastroesophageal Reflux Disease
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Gastroesophageal Reflux Disease
Intervention  ICMJE Drug: Rabeprazole 20 mg
rabeprazole sodium tablet 20 mg once daily
Other Name: rabeprazole
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Rabeprazole 20 mg
  • Experimental: Rabeprazole 20 mg
    Intervention: Drug: Rabeprazole 20 mg
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2009)
200
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
340
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00165841
Other Study ID Numbers  ICMJE E3810-A001-203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yufang Lu, Study Director, Eisai Medical Research Inc.
Study Sponsor  ICMJE Eisai Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yufang Lu Eisai Inc.
PRS Account Eisai Inc.
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP