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

Purpose

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	Intervention	Phase
Gastroesophageal Reflux Disease (GERD)	Drug: Rabeprazole ER Drug: Ranitidine	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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)

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Ranitidine Ranitidine Hydrochloride Rabeprazole Rabeprazole sodium

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

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 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:

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, and Gastrin), Gastric Biopsies, Physical Exam, and Vital Signs. [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
Information presented within Adverse Event information.


Enrollment:	240
Study Start Date:	August 2008
Study Completion Date:	December 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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).

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
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:

Esophageal motility disorders (achalasia, scleroderma, or esophageal spasm).
Barrett's esophagus or esophageal stricture.
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.
Subjects who require chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (>= 20 mg/day prednisone or equivalent), or aspirin (->; 325 mg/day).
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.
Any condition that would make the subject, in the opinion of the investigator or sponsor, unsuitable for the study.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00838526 History of Changes
Other Study ID Numbers:	E3810-G000-305
Study First Received:	February 5, 2009
Results First Received:	June 8, 2015
Last Updated:	October 15, 2015
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 27, 2016