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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)

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ClinicalTrials.gov Identifier: NCT00658528
Recruitment Status : Completed
First Posted : April 15, 2008
Results First Posted : June 23, 2015
Last Update Posted : December 21, 2015
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Tracking Information
First Submitted Date  ICMJE April 9, 2008
First Posted Date  ICMJE April 15, 2008
Results First Submitted Date  ICMJE June 8, 2015
Results First Posted Date  ICMJE June 23, 2015
Last Update Posted Date December 21, 2015
Study Start Date  ICMJE February 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2015)
  • Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks [ Time Frame: Baseline and Week 8 ]
    Healing at week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade C or D from Baseline. Classifications include: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present). Grade A: One or more mucosal breaks not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds. Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference. Gread D: Mucosal breaks involving at least 75% of the esophageal circumference.
  • Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks [ Time Frame: Baseline and Week 4 ]
    Healing at week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade C or D from Baseline. Classifications include: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present). Grade A: One or more mucosal breaks not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds. Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference. Grade D: Mucosal breaks involving at least 75% of the esophageal circumference.
Original 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. ]
Change History Complete list of historical versions of study NCT00658528 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2015)
Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4 [ Time Frame: Week 4 ]
During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of hearburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.
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. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
Official Title  ICMJE 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)
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gastroesophageal 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  ICMJE
  • Experimental: 1
    Intervention: Drug: Rabeprazole sodium
  • Active Comparator: 2
    Intervention: Drug: Esomeprazole
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2015)
1061
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2008)
1060
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date September 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Bulgaria,   Canada,   Chile,   Croatia,   Estonia,   France,   Germany,   Hungary,   India,   Latvia,   United States
Removed Location Countries Lithuania,   Mexico,   New Zealand,   Poland,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Ukraine
 
Administrative Information
NCT Number  ICMJE NCT00658528
Other Study ID Numbers  ICMJE E3810-G000-301
2007-005570-32 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eisai Inc.
Study Sponsor  ICMJE Eisai Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yufang Lu, MD, PhD Eisai Inc.
PRS Account Eisai Inc.
Verification Date November 2015

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