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


Tracking Information

tart Date  ICMJEFebruary 2008
Estimated Primary Completion DateSeptember 2009   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2008)		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 ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00658528 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: November 17, 2008)		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: No ]
Original Secondary Outcome Measures ICMJE 
 (submitted: April 14, 2008)		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 ]

Descriptive Information

Brief Title  ICMJERabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
Official Title  ICMJEA 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)
Brief Summary

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).

Detailed Description

This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all of 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 PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEGastroesophageal Reflux Disease (GERD)
Intervention  ICMJE
  • Drug: Rabeprazole sodium
    Rabeprazole ER 50 mg capsule, taken orally, once daily for 4-8 weeks.
    Other Name: Aciphex
  • Drug: Esomeprazole
    Esomeprazole 40 mg capsule, taken orally, once daily for 4-8 weeks.
Study Arms / Comparison Groups
  • 1: Experimental
    Intervention: Drug: Rabeprazole sodium
  • 2: Active Comparator
    Intervention: Drug: Esomeprazole

Recruitment Information

Estimated Enrollment  ICMJE1060
Completion Date 
Estimated Primary Completion DateSeptember 2009   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. Current esophageal strictures or esophagitis (known or suspected to be due to etiology other than GERD such as infection or medications).
  3. Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.
  4. Current or a history of cancer, with the exception of fully excised skin basal cell carcinoma.
  5. Inflammatory bowel disease.
  6. Unstable diabetes mellitus.
  7. History of esophageal, gastric and duodenal surgery except simple suturing of an ulcer.
  8. Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (>= 20 mg/day prednisone or equivalent), or aspirin (> 325 mg/day).
GenderBoth
Ages18 Years to 75 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Eisai Medical Research1-201-403-2500
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Bulgaria,   Canada,   Chile,   Croatia,   Estonia,   France,   Germany,   Hungary,   India,   Latvia,   Lithuania,   Mexico,   New Zealand,   Poland,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Ukraine

Administrative Information

NCT ID  ICMJENCT00658528
Responsible PartyYufang Lu, Study Director, Eisai Medical Research Inc.
Study ID Numbers  ICMJEE3810-G000-301
Study Sponsor  ICMJEEisai Inc.
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Yufang Lu, MD, PhDEisai Inc.
Information Provided ByEisai Inc.