Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)

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. Identifier: NCT00838526
Recruitment Status : Completed
First Posted : February 6, 2009
Results First Posted : June 23, 2015
Last Update Posted : November 11, 2015
Information provided by (Responsible Party):
Eisai Inc.

February 5, 2009
February 6, 2009
June 8, 2015
June 23, 2015
November 11, 2015
August 2008
July 2009   (Final data collection date for primary outcome measure)
Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26 [ Time Frame: Baseline to Week 26 ]

eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).

Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.

Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.

Grade D: Mucosal breaks involving at least 75% of the esophageal circumference.

The primary outcome measure will include: esophagogastroduodenoscopy (EGD), Investigator's assessment of symptoms, quality of life as recorded by subjects and concomitant use of dispensed antacid. [ Time Frame: Week 13 and Week 26. ]
Complete list of historical versions of study NCT00838526 on Archive Site
  • Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26 [ Time Frame: Baseline to Week 26 ]
    Heartburn or other GERD-associated symptoms (regurgitation, epigastric or chest pain, dysphagia, belching, bloating, early satiety, other) was based on a 4-point Likert scale that included the following: None (No symptoms); Mild (Awareness of symptoms but easily tolerated); Moderate (Discomforting symptom sufficient to cause interference with normal activities including sleep); Severe (Incapacitating symptom, inability to perform normal activities).
  • Secondary Outcome Measures Will Include: Adverse Events, Electrocardiograms (ECGs), Laboratory Evaluations (Hematology, Blood Chemistry, Urinalysis, and Gastrin), Gastric Biopsies, Physical Exam, and Vital Signs. [ Time Frame: Baseline to Week 26 ]
    Information presented within Adverse Event information.
Secondary outcome measures will include: adverse events, electrocardiograms (ECGs), laboratory evaluations (hematology, blood chemistry, urinalysis, gastrin), gastric biopsies, physical exam and vital signs. [ Time Frame: Week 13 and Week 26. ]
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Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
The purpose of this study is to compare the efficacy of rabeprazole extended release (ER) 50 mg (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing in subjects with healed erosive gastroesophageal reflux disease (eGERD).
This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all eligibility criteria will be randomly assigned to 1 of 2 treatment groups, RAB ER 50 mg (once daily) or Ranitidine 150 mg (twice daily).
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Gastroesophageal Reflux Disease (GERD)
  • Drug: Rabeprazole ER
    50 mg capsule, taken orally, once daily for 26 weeks.
    Other Name: Aciphex
  • Drug: Ranitidine
    150 mg capsule, taken orally, twice daily for 26 weeks.
  • Experimental: 1
    Intervention: Drug: Rabeprazole ER
  • Active Comparator: 2
    Intervention: Drug: Ranitidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2009
July 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

1. Prior completion of Study E3810-G000-301 or -303. Subjects will need to have healed erosive esophagitis (absence of esophageal mucosal breaks or erosions) confirmed by EGD and sustained resolution of heartburn at Visit 4 or 5 of Study E3810-G000-301 or -303.

Exclusion Criteria:

  1. Esophageal motility disorders (achalasia, scleroderma, or esophageal spasm).
  2. Barrett's esophagus or esophageal stricture.
  3. Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine receptor antagonists (H2RA), antacids, sucralfate, misoprostol, prokinetics or drugs with significant anticholinergic effects throughout the study.
  4. Subjects who require chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (>= 20 mg/day prednisone or equivalent), or aspirin (->; 325 mg/day).
  5. Significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities that would be likely to interfere with the conduct of the study, the interpretation of study results, or the health of the subject during the study.
  6. Any condition that would make the subject, in the opinion of the investigator or sponsor, unsuitable for the study.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Guillermo Rossiter, MD Eisai Inc.
Eisai Inc.
October 2015

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