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

Primary Purpose

Gastroesophageal Reflux Disease (GERD)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rabeprazole ER
Ranitidine
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD) focused on measuring Gastroesophageal, Reflux, Disease, GERD

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Associates, Ltd.
  • Midwest Clinical
  • Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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 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.

Secondary Outcome Measures

Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at 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).

Full Information

First Posted
February 5, 2009
Last Updated
January 11, 2016
Sponsor
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00839306
Brief Title
Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.

4. Oversight

5. Study Description

Brief Summary
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).
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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease (GERD)
Keywords
Gastroesophageal, Reflux, Disease, GERD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rabeprazole ER
Other Intervention Name(s)
Aciphex
Intervention Description
50 mg capsule, taken orally, once daily for 26 weeks.
Intervention Type
Drug
Intervention Name(s)
Ranitidine
Intervention Description
150 mg capsule, taken orally, twice daily for 26 weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26
Description
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.
Time Frame
Baseline to Week 26
Secondary Outcome Measure Information:
Title
Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26
Description
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).
Time Frame
Baseline to Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Rossiter, M.D.
Organizational Affiliation
Eisai Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Associates, Ltd.
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Midwest Clinical
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Research
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States

12. IPD Sharing Statement

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

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