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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00839306
First received: February 5, 2009
Last updated: January 11, 2016
Last verified: January 2016

February 5, 2009
January 11, 2016
August 2008
August 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 ] [ Designated as safety issue: No ]

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 oesophageal 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. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00839306 on ClinicalTrials.gov Archive Site
Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
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, gastrin), gastric biopsies, physical exam and vital signs. [ Time Frame: Week 13 and week 26. ] [ Designated as safety issue: Yes ]
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Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
A Randomized Double-Blind Parallel Study of Rabeprazole Extended Release 50 mg Versus 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 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, rabeprazole extended release 50 mg (once daily) or ranitidine 150 mg (twice daily).

Please note that this study is not a duplicate of E3810-G000-305; this is a separate study being conducted along with -305.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
January 2010
August 2009   (final data collection date for primary outcome measure)

KEY INCLUSION CRITERIA:

1. Prior completion of Study E3810-G000-302 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-G000-302 or -303.

KEY 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.
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00839306
E3810-G000-306
Not Provided
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Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Guillermo Rossiter, M.D. Eisai Inc.
Eisai Inc.
January 2016

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