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

March 17, 2010
November 27, 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) ] [ Designated as safety issue: No ]
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 symptom at last visit in treatment period [ Time Frame: 8 week ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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 symptom at last visit in treatment period [ Time Frame: 8 week ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01089543
E3810-J081-204
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