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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)

This study is currently recruiting participants.
Verified by Eisai Medical Research Inc., March 2008

Sponsored by: Eisai Medical Research Inc.
Information provided by: Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00658528
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux Disease (GERD)
Drug: Rabeprazole sodium
Drug: Esomeprazole
Phase III

MedlinePlus related topics:   GERD   

ChemIDplus related topics:   Esomeprazole magnesium    Esomeprazole Sodium    Omeprazole    Omeprazole magnesium    E 3810   

U.S. FDA Resources

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

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:
  • Upper GI endoscopy (EGD), symptoms based on subject's daily diary and investigator's assessment. [ Time Frame: Every 4-8 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events, ECGs, laboratory evaluations (hematology, blood chemistry, urinalysis, serum gastrin), physical examinations, vital signs. [ Time Frame: Every 4-8 weeks. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   1060
Study Start Date:   February 2008
Estimated Primary Completion Date:   August 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Drug: Rabeprazole sodium
Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks.
2: Active Comparator Drug: Esomeprazole
Esomeprazole 40 mg capsule, once daily for 4-8 weeks.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658528

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

Locations
United States, California
Advanced Clinical Research Institute     Recruiting
      Anaheim, California, United States, 92801

Sponsors and Collaborators
Eisai Medical Research Inc.

Investigators
Study Director:     Yufang Lu, MD, PhD     Eisai Medical Research Inc.    
  More Information


Responsible Party:   Eisai Medical Research Inc. ( Yufang Lu, Study Director )
Study ID Numbers:   E3810-G000-301
First Received:   April 9, 2008
Last Updated:   April 14, 2008
ClinicalTrials.gov Identifier:   NCT00658528
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases
Omeprazole
Esophageal Diseases
Gastroesophageal Reflux
Rabeprazole

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008




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