A Study of E3810 for Japanese Subjects With Functional Dyspepsia (SAMURAI Study: Suppression of Acid Milieu With Rabeprazole Improving Functional Dyspepsia ) (Study E3810-J081-204)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01089543
First received: March 17, 2010
Last updated: November 27, 2013
Last verified: November 2013
Results First Received: September 17, 2013  
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: Functional Dyspepsia
Interventions: Drug: Rabeprazole
Drug: Placebo

  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
This study was recruited at 66 centers in Japan during the period of 21-April-2010 to 12-Aug-2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were initially enrolled into a 1- or 2-week run-in period (single-blinded administration of placebo). Participants who did not respond to placebo were randomized to an 8-week treatment period (double-blinded administration) of rabeprazole 10 mg, 20 mg, 40 mg, or placebo, once daily after breakfast.

Reporting Groups
  Description
Rabeprazole 10 mg Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
Rabeprazole 20 mg Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
Rabeprazole 40 mg Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
Placebo Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.

Participant Flow:   Overall Study
    Rabeprazole 10 mg     Rabeprazole 20 mg     Rabeprazole 40 mg     Placebo  
STARTED     84     85     84     85  
COMPLETED     81     81     81     83  
NOT COMPLETED     3     4     3     2  
Withdrawal by Subject                 2                 3                 3                 1  
Physician Decision                 1                 0                 0                 1  
Adverse Event                 0                 1                 0                 0  



  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.
Per Protocol Set (PPS): was defined as those participants who complied with the study protocol. N= 338 participants were enrolled at study start. However, a total of 307 participants were included in PPS for efficacy evaluation.

Reporting Groups
  Description
Rabeprazole 10 mg Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
Rabeprazole 20 mg Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
Rabeprazole 40 mg Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
Placebo Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
Total Total of all reporting groups

Baseline Measures
    Rabeprazole 10 mg     Rabeprazole 20 mg     Rabeprazole 40 mg     Placebo     Total  
Number of Participants  
[units: participants]
  77     76     74     80     307  
Age  
[units: years]
Mean ± Standard Deviation
  46.9  ± 14.9     50.2  ± 16.5     46.4  ± 14.8     45.8  ± 15.5     47.3  ± 15.5  
Gender  
[units: participants]
         
Female     43     40     47     44     174  
Male     34     36     27     36     133  



  Outcome Measures
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1.  Primary:   Rate of Complete Dyspepsia Symptom Relief   [ Time Frame: Up to 8 Weeks (including 7 days prior) ]

2.  Secondary:   Rate of Satisfactory Symptom Relief   [ Time Frame: Up to 8 Weeks (including 7 days prior) ]


  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: Yoshiumi Okubo, Study Director
Organization: Eisai Inc.
phone: +81-3-3817-3908
e-mail: y4-okubo@hhc.eisai.co.jp


No publications provided by Eisai Inc.

Publications automatically indexed to this study:

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01089543     History of Changes
Other Study ID Numbers: E3810-J081-204
Study First Received: March 17, 2010
Results First Received: September 17, 2013
Last Updated: November 27, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare