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

Phase 3

Completed

• Conditions: Gastroesophageal Reflux Disease (GERD)
• Interventions: Drug: Rabeprazole ER; Drug: Ranitidine

• Registration Number: NCT00838526
• Lead Sponsor: Eisai Inc.

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).

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 Timeline

• Study Start: 2008-08-31
• Study First Submitted: 2009-02-05
• Study First Submitted QC: 2009-02-05
• Study First Posted: 2009-02-06
• Primary Completion: 2009-07-31
• Study Completion: 2009-12-31
• Results First Submitted: 2015-06-08
• Results First Submitted QC: 2015-06-08
• Results First Posted: 2015-06-23
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rabeprazole ER	-
2	Ranitidine	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26	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

Name	Time	Method
Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26	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).
Percentage of Participants With Adverse Events by Category	From the time of administration of the first dose of study drug up to a maximum of approximately 30 weeks.	An adverse event (AE) was any untoward medical occurrence in a participant administered an investigational product. A treatment emergent AE (TEAE) was any AE beginning on or after the confirmed date of first dose of study medication, up to and including 7 days after the last dose of study medication. A TEAE was considered related to study treatment if a causal relationship between the study treatment and the AE was a reasonable possibility. AEs were graded as severe if they were incapacitating, with inability to work or to perform normal daily activity. Serious AEs (SAEs) were events that resulted in death, were life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or were a congenital anomaly/birth defect.

Trial Locations

Locations (3)

Ltd.; 🇺🇸 Moline, Illinois, United States

Research Associates; 🇺🇸 Moline, Illinois, United States

Midwest Clinical; 🇺🇸 Moline, Illinois, United States