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

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

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease (GERD) Drug: Rabeprazole ER Drug: Ranitidine Phase 3

Detailed Description:
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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
Study Start Date : August 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Rabeprazole ER
50 mg capsule, taken orally, once daily for 26 weeks.
Other Name: Aciphex
Active Comparator: 2 Drug: Ranitidine
150 mg capsule, taken orally, twice daily for 26 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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).

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838526


Locations
United States, Illinois
Ltd.
Moline, Illinois, United States, 61265
Midwest Clinical
Moline, Illinois, United States, 61265
Research Associates
Moline, Illinois, United States, 61265
Moline, Illinois, United States, 61265
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Guillermo Rossiter, MD Eisai Inc.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00838526     History of Changes
Other Study ID Numbers: E3810-G000-305
First Posted: February 6, 2009    Key Record Dates
Results First Posted: June 23, 2015
Last Update Posted: November 11, 2015
Last Verified: October 2015

Keywords provided by Eisai Inc.:
Gastroesophageal
Reflux
Disease
GERD

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rabeprazole
Ranitidine
Ranitidine bismuth citrate
Anti-Ulcer Agents
 Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs