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 ongoing, but not recruiting participants.

First Received: April 9, 2008 Last Updated: August 27, 2009 History of Changes

Sponsor:	Eisai Inc.
Information provided by:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00658775

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, Rabeprazole Extended-Release (RAB ER) 50 mg or Esomeprazole (ESO) 40 mg for the treatment of moderate to severe erosive Gastroesophageal Reflux Disease (GERD).

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, 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)

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Omeprazole Omeprazole magnesium E 3810 Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Upper GI esophagogastroduodenoscopy (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, electrocardiograms (ECGs), lab evaluations (hematology, blood chemistry, urinalysis, serum gastrin), physical exams, 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:	September 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 Los Angeles (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: NCT00658775

Show 176 Study Locations

Sponsors and Collaborators

Eisai Inc.

Investigators

Study Director:

Yufang Lu

Eisai Inc.

More Information

No publications provided

Responsible Party:	Eisai Medical Research Inc. ( Yufang Lu, Study Director )
Study ID Numbers:	E3810-G000-302
Study First Received:	April 9, 2008
Last Updated:	August 27, 2009
ClinicalTrials.gov Identifier:	NCT00658775 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions

Esophageal Motility Disorders
Deglutition Disorders
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases
Rabeprazole

ClinicalTrials.gov processed this record on February 08, 2010