Phase 3
N=1,065
Rabeprazole Extended-Release, 50 mg, Versus Esomeprazole, 40 mg, for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
Gastroesophageal Reflux Disease (GERD)
Bottom Line
View on ClinicalTrials.gov: NCT00658775 ↗Enrolled (actual)
1,065
Serious AEs
0.6%
Results posted
Jun 2015
Primary outcome: Primary: Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks — 78.4; 77.5; 16.6; 18.4 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rabeprazole sodium (Drug); Esomeprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eisai Inc.
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks |
78.4; 77.5; 16.6; 18.4; 5; 4.2 | — |
| PRIMARY Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks |
50.7; 50.9; 46.4; 47; 3; 2.1 | — |
| SECONDARY Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4 |
52.5; 53.2; 40; 39.6; 7.4; 7.2 | — |
Summary
The purpose of this study is to investigate the efficacy (ie, healing and symptom relief) and safety of Rabeprazole Extended-Release (RAB ER) 50 mg versus Esomeprazole (ESO) 40 mg for the treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).
Eligibility Criteria
KEY INCLUSION CRITERIA
- Male or female, ages 18 to 75 years.
- History of GERD symptoms for at least 3 months immediately before screening.
- Heartburn for at least 2 days a week for at least 1 month before screening.
- Esophageal erosions of LA Grades C or D based on EGD taken within 14 days prior to enrollment.
- Subjects who are H. pylori negative based on a screening test.
- Females should be either of non-childbearing potential or of childbearing potential. Females of childbearing potential must have negative pregnancy tests prior to randomization. Female subjects of childbearing potential must agree to use medically acceptable methods of contraception.
- Subjects must be able to read, write, and understand the language of the symptom diary.
KEY EXCLUSION CRITERIA
- Current or a history of esophageal motility disorders.
- Current or a history of Barrett's esophagus.
- Current esophageal strictures or esophagitis (known or suspected to be due to etiology other than GERD such as infection or medications).
- Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.
- Current or a history of cancer, with the exception of fully excised skin basal cell carcinoma.
- Inflammatory bowel disease.
- Unstable diabetes mellitus.
- History of esophageal, gastric and duodenal surgery except simple suturing of an ulcer.
- Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (>= 20 mg/day prednisone or equivalent), or aspirin (> 325 mg/day).
Data sourced from ClinicalTrials.gov (NCT00658775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.