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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:
ClinicalTrials.gov Identifier:
NCT01089543
First Posted: March 18, 2010
Last Update Posted: December 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
March 17, 2010
March 18, 2010
September 17, 2013
November 19, 2013
December 24, 2013
April 2010
August 2011   (Final data collection date for primary outcome measure)
Rate of Complete Dyspepsia Symptom Relief [ Time Frame: Up to 8 Weeks (including 7 days prior) ]
The rate of complete dyspepsia symptom relief according to the Dyspepsia Symptom Questionnaire (DSQ) was defined as a score of 1 for all four major dyspeptic symptoms at week 8 and according to the diary defined as all four dyspepsia symptoms recorded absent during the 7 days prior to week 8. Values presented as percentage of participants.
Resolution rate of dyspeptic symptoms at last visit in treatment period [ Time Frame: 8 weeks ]
Complete list of historical versions of study NCT01089543 on ClinicalTrials.gov Archive Site
Rate of Satisfactory Symptom Relief [ Time Frame: Up to 8 Weeks (including 7 days prior) ]
The rate of satisfactory symptom relief according to the DSQ defined as scores of <= 2 for all four major dyspepsia symptoms at week 8 and the diary recordings defined as a frequency of <= 1 day for all four major dyspepsia symptoms during the 7 days before week 8. Lastly, treatment success according to the participants' impression questionnaire where participants answered "yes" or "no" when asked if given the choice, whether they would want to continue to take the study drug after clinical trial completion. Values presented as percentage of participants.
Response rate of dyspeptic symptoms at last visit in treatment period [ Time Frame: 8 weeks ]
Not Provided
Not Provided
 
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)
A Multi-Center, Randomized, Double-Blind Study of E3810 for Japanese Subjects With Functional Dyspepsia
The purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in Japanese subjects with Functional Dyspepsia.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Functional Dyspepsia
  • Drug: Rabeprazole
    Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
    Other Name: E3810
  • Drug: Rabeprazole
    Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
    Other Name: E3810
  • Drug: Rabeprazole
    Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
    Other Name: E3810
  • Drug: Placebo
    Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
    Other Name: E3810
  • Experimental: Rabeprazole 10 mg
    Intervention: Drug: Rabeprazole
  • Experimental: Rabeprazole 20 mg
    Intervention: Drug: Rabeprazole
  • Experimental: Rabeprazole 40 mg
    Intervention: Drug: Rabeprazole
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Iwakiri R, Tominaga K, Furuta K, Inamori M, Furuta T, Masuyama H, Kanke K, Nagahara A, Haruma K, Kinoshita Y, Higuchi K, Takahashi S, Kusano M, Iwakiri K, Kato M, Hongo M, Hiraishi H, Watanabe S, Miwa H, Naito Y, Fujimoto K, Arakawa T. Randomised clinical trial: rabeprazole improves symptoms in patients with functional dyspepsia in Japan. Aliment Pharmacol Ther. 2013 Oct;38(7):729-40. doi: 10.1111/apt.12444. Epub 2013 Aug 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
338
August 2011
August 2011   (Final data collection date for primary outcome measure)

Inclusion criteria:

-Participants diagnosed as Functional Dyspepsia according to Rome III criteria.

Exclusion criteria:

  • Participants with neuropsychiatric disorder.
  • Participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation.
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01089543
E3810-J081-204
Not Provided
Not Provided
Not Provided
Eisai Inc. ( Eisai Co., Ltd. )
Eisai Co., Ltd.
Not Provided
Study Director: Yoshiumi Okubo Eisai Co., Ltd.
Eisai Inc.
November 2013

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