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Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00838526
First received: February 5, 2009
Last updated: October 15, 2015
Last verified: October 2015
Results First Received: June 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Gastroesophageal Reflux Disease (GERD)
Interventions: Drug: Rabeprazole ER
Drug: Ranitidine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were eligible for this study if they had completed one of the healing studies (E3810-G000-301 or E3810-G000-303), had no evidence of oesophageal erosions, had sustained heartburn resolution, and had no record of any serious adverse event (SAE) related to study medication during the healing study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of the 240 participants who were randomized in this study, 235 participants received study treatment.

Reporting Groups
  Description
RAN 150mg BID Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
RAB ER 50mg QD Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.

Participant Flow:   Overall Study
    RAN 150mg BID   RAB ER 50mg QD
STARTED   59 [1]   176 [1] 
COMPLETED   35   137 
NOT COMPLETED   24   39 
Adverse Event                3                12 
Lost to Follow-up                4                12 
Withdrawal by Subject                4                5 
Lack of Efficacy                2                3 
Not specified                11                7 
[1] Treated



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
RAN 150mg BID Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
RAB ER 50mg QD Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
Total Total of all reporting groups

Baseline Measures
   RAN 150mg BID   RAB ER 50mg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 59   176   235 
Age, Customized 
[Units: Years]
Mean (Standard Deviation)
 46.7  (12.15)   46.4  (12.83)   46.5  (12.64) 
Gender 
[Units: Participants]
     
Female   27   81   108 
Male   32   95   127 


  Outcome Measures
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1.  Primary:   Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26   [ Time Frame: Baseline to Week 26 ]

2.  Secondary:   Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26   [ Time Frame: Baseline to Week 26 ]

3.  Secondary:   Secondary Outcome Measures Will Include: Adverse Events, Electrocardiograms (ECGs), Laboratory Evaluations (Hematology, Blood Chemistry, Urinalysis, and Gastrin), Gastric Biopsies, Physical Exam, and Vital Signs.   [ Time Frame: Baseline to Week 26 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Eisai Inc.
Organization: Eisai Call Center
phone: 888-422-4743



Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00838526     History of Changes
Other Study ID Numbers: E3810-G000-305
Study First Received: February 5, 2009
Results First Received: June 8, 2015
Last Updated: October 15, 2015
Health Authority: United States: Food and Drug Administration