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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00658528
First received: April 9, 2008
Last updated: June 30, 2014
Last verified: March 2010

April 9, 2008
June 30, 2014
February 2008
September 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00658528 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
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)

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Gastroesophageal Reflux Disease (GERD)
  • 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.
  • Experimental: 1
    Intervention: Drug: Rabeprazole sodium
  • Active Comparator: 2
    Intervention: Drug: Esomeprazole
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. doi: 10.1111/j.1365-2036.2010.04516.x. Epub 2010 Nov 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1060
January 2010
September 2009   (final data collection date for primary outcome measure)

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).
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Bulgaria,   Canada,   Chile,   Croatia,   Estonia,   France,   Germany,   Hungary,   India,   Latvia
 
NCT00658528
E3810-G000-301, 2007-005570-32
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Yufang Lu, MD, PhD Eisai Inc.
Eisai Inc.
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP