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

Sponsor:	Eisai Inc.
Information provided by:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00658528

Purpose

The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (GERD).

Condition	Intervention	Phase
Gastroesophageal Reflux Disease (GERD)	Drug: Rabeprazole sodium Drug: Esomeprazole	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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 Rabeprazole Rabeprazole sodium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by Eisai 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, Electrocardiograms (ECGs), laboratory evaluations (hematology, blood chemistry, urinalysis, serum gastrin), physical examinations, vital signs. [ Time Frame: Every 4-8 weeks. ] [ Designated as safety issue: Yes ]

Enrollment:	1060
Study Start Date:	February 2008
Study Completion Date:	January 2010
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

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

Detailed Description:

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 ER 50 mg or Esomeprazole 40 mg for the treatment of moderate to severe erosive GERD.

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: NCT00658528

Show 88 Study Locations

Sponsors and Collaborators

Eisai Inc.

Investigators

Study Director:

Yufang Lu, MD, PhD

Eisai Inc.

More Information

No publications provided by Eisai Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Laine L, Katz PO, Johnson DA, Ibegbu I, Goldstein MJ, Chou C, Rossiter G, Lu Y. Randomised clinical trial: a novel rabeprazole extended release 50 mg formulation vs. esomeprazole 40 mg in healing of moderate-to-severe erosive oesophagitis - the results of two double-blind studies. Aliment Pharmacol Ther. 2011 Jan;33(2):203-12. Epub 2010 Nov 30.

Responsible Party:	Yufang Lu, Study Director, Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00658528 History of Changes
Other Study ID Numbers:	E3810-G000-301
Study First Received:	April 9, 2008
Last Updated:	March 10, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eisai Inc.:

GERD
erosive GERD
erosive esophagitis

Additional relevant MeSH terms:

Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole

Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2012