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)”

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, RAB ER 50 mg or ESO 40 mg for the treatment of moderate to severe erosive GERD.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2009

Intervention(s) in this Clinical Trial

• Drug: Rabeprazole sodium
  • Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks.
• Drug: Esomeprazole
  • Esomeprazole 40 mg capsule, once daily for 4-8 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Upper GI endoscopy (EGD), symptoms based on subject's daily diary and investigator's assessment.
  • Time Frame: Every 4-8 weeks.
    Safety Issue?: No

Secondary Measures

• Adverse events, ECGs, laboratory evaluations (hematology, blood chemistry, urinalysis, serum gastrin), physical examinations, vital signs.
  • Time Frame: Every 4-8 weeks.
    Safety Issue?: Yes

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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eisai Medical Research Inc.

Overall Clinical Trial Officials and Contacts

Yufang Lu, MD, PhD Study Director Eisai Medical Research Inc.  

Overall Contact: Eisai Medical Research Inc. 1-201-403-2500 

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00658528

Study ID Number: E3810-G000-301

ClinicalTrials.gov Identifier: NCT00658528

Health Authority: United States: Food and Drug Administration