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Rabeprazole Extended-Release, 50 mg, Versus Esomeprazole, 40 mg, for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)

Information source: Eisai Medical Research Inc.
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastroesophageal Reflux Disease (GERD)

Intervention: Rabeprazole sodium (Drug); Esomeprazole (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Eisai Medical Research Inc.

Official(s) and/or principal investigator(s):
Yufang Lu, Study Director, Affiliation: Eisai Medical Research Inc.

Overall contact:
Eisai Medical Research, Phone: 201403- 2550

Summary

This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, Rabeprazole Extended-Release (RAB ER) 50 mg or Esomeprazole (ESO) 40 mg for the treatment of moderate to severe erosive Gastroesophageal Reflux Disease (GERD).

Clinical Details

Official title: A Randomized, Double-Blind, Parallel Study of Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Upper GI esophagogastroduodenoscopy (EGD), symptoms based on subject's daily diary and investigator's assessment.

Secondary outcome: Adverse events, electrocardiograms (ECGs), lab evaluations (hematology, blood chemistry, urinalysis, serum gastrin), physical exams, vital signs.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

KEY INCLUSION CRITERIA:

1. Male or female, ages 18 to 75 years.

2. History of GERD symptoms for at least 3 months immediately before screening.

3. Heartburn for at least 2 days a week for at least 1 month before screening.

4. Esophageal erosions of Los Angeles (LA) Grades C or D based on EGD taken within 14 days prior to enrollment.

5. Subjects who are H. pylori negative based on a screening test.

6. 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.

7. Subjects must be able to read, write, and understand the language of the symptom diary.

KEY EXCLUSION CRITERIA:

1. Current or a history of esophageal motility disorders.

2. Current or a history of Barrett's esophagus.

3. Current esophageal strictures or esophagitis (known or suspected to be due to etiology other than GERD such as infection or medications).

4. Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.

5. Current or a history of cancer, with the exception of fully excised skin basal cell carcinoma.

6. Inflammatory bowel disease.

7. Unstable diabetes mellitus.

8. History of esophageal, gastric and duodenal surgery except simple suturing of an ulcer.

9. Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (>= 20 mg/day prednisone or equivalent), or aspirin (> 325 mg/day).

Locations and Contacts

Eisai Medical Research, Phone: 201403- 2550

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Additional Information

Starting date: February 2008
Last updated: November 18, 2008

Page last updated: February 12, 2009

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