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

NCT00838526 | Completed Phase 3 Results

• 1 other identifier: E3810-G000-305
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

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).

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

Gastroesophageal; Reflux; Disease; GERD

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Maintenance of Complete Healing of eGERD at 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.

  Baseline to Week 26

Secondary Outcomes (2)

• Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26

  Baseline to Week 26

• 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.

Study Arms (2)

1

EXPERIMENTAL

Drug: Rabeprazole ER

2

ACTIVE COMPARATOR

Drug: Ranitidine

Interventions

Rabeprazole ER DRUG

50 mg capsule, taken orally, once daily for 26 weeks.

Also known as: Aciphex

1

Ranitidine DRUG

150 mg capsule, taken orally, twice daily for 26 weeks.

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (4)

Ltd.

Moline, Illinois, 61265, United States

Location

Midwest Clinical

Moline, Illinois, 61265, United States

Location

Research Associates

Moline, Illinois, 61265, United States

Location

Unknown Facility

Moline, Illinois, 61265, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Disease

Interventions

Rabeprazole; Ranitidine

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Furans

Results Point of Contact

• Title: Eisai Medical Information, Eisai
• Organization: Eisai Inc.

esi_medinfo@eisai.com

+1 888 274 2378

Study Officials

• Guillermo Rossiter, MD

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 6, 2009
• Study Start: August 31, 2008
• Primary Completion: July 31, 2009
• Study Completion: December 31, 2009
• Last Updated: April 25, 2022
• Results First Posted: June 23, 2015

Record last verified: 2022-03

Locations

US (4)