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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00658528
First received: April 9, 2008
Last updated: November 19, 2015
Last verified: November 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 sodium
Drug: Esomeprazole

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 1061 participants who were randomized, 1055 participants received study treatment.

Reporting Groups
  Description
ESO 40 mg Esomeprazole (ESO) 40 mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50 mg capsule), once daily for 4 to 8 weeks.
RAB ER 50 mg Rabeprazole (RAB) Extended Release (ER) 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.

Participant Flow:   Overall Study
    ESO 40 mg   RAB ER 50 mg
STARTED   531 [1]   524 [1] 
COMPLETED   491   479 
NOT COMPLETED   40   45 
Adverse Event                5                7 
Lost to Follow-up                14                22 
Withdrawal by Subject                8                6 
Withdrawal of consent                5                6 
Not specified                8                4 
[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
ESO 40 mg ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
RAB ER 50 mg RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
Total Total of all reporting groups

Baseline Measures
   ESO 40 mg   RAB ER 50 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 531   524   1055 
Age 
[Units: Years]
Mean (Standard Deviation)
 49  (13.09)   48  (13.38)   48.5  (13.23) 
Gender 
[Units: Participants]
     
Female   206   202   408 
Male   325   322   647 


  Outcome Measures
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1.  Primary:   Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks   [ Time Frame: Baseline and Week 8 ]

2.  Primary:   Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks   [ Time Frame: Baseline and Week 4 ]

3.  Secondary:   Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4   [ Time Frame: Week 4 ]


  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


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

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00658528     History of Changes
Other Study ID Numbers: E3810-G000-301
2007-005570-32 ( EudraCT Number )
Study First Received: April 9, 2008
Results First Received: June 8, 2015
Last Updated: November 19, 2015
Health Authority: United States: Food and Drug Administration