Trial Outcomes & Findings for 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) (NCT NCT01089543)

Last Updated: 2013-12-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

338 participants

Primary outcome timeframe

Up to 8 Weeks (including 7 days prior)

Results posted on

2013-12-24

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	84	85	84	85
Overall Study COMPLETED	81	81	81	83
Overall Study NOT COMPLETED	3	4	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	2	3	3	1
Overall Study Physician Decision	1	0	0	1
Overall Study Adverse Event	0	1	0	0

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rabeprazole 10 mg n=77 Participants Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.	Rabeprazole 20 mg n=76 Participants Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.	Rabeprazole 40 mg n=74 Participants Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.	Placebo n=80 Participants Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.	Total n=307 Participants Total of all reporting groups
Age, Continuous	46.9 years STANDARD_DEVIATION 14.9 • n=5 Participants	50.2 years STANDARD_DEVIATION 16.5 • n=7 Participants	46.4 years STANDARD_DEVIATION 14.8 • n=5 Participants	45.8 years STANDARD_DEVIATION 15.5 • n=4 Participants	47.3 years STANDARD_DEVIATION 15.5 • n=21 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	40 Participants n=7 Participants	47 Participants n=5 Participants	44 Participants n=4 Participants	174 Participants n=21 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	36 Participants n=7 Participants	27 Participants n=5 Participants	36 Participants n=4 Participants	133 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 8 Weeks (including 7 days prior)

Population: Per Protocol Set (PPS) population defined as those participants who complied with the study protocol.

Outcome measures

Outcome measures
Measure	Rabeprazole 10 mg n=77 Participants Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.	Rabeprazole 20 mg n=76 Participants Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.	Rabeprazole 40 mg n=74 Participants Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.	Placebo n=80 Participants Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
Rate of Complete Dyspepsia Symptom Relief DSQ (n= 76, n= 75, n= 74, n= 78)	22.4 Percentage of Participants	29.3 Percentage of Participants	27.0 Percentage of Participants	17.9 Percentage of Participants
Rate of Complete Dyspepsia Symptom Relief Diary Recordings (n= 77, n= 76, n=74, n=80)	22.1 Percentage of Participants	28.9 Percentage of Participants	27.0 Percentage of Participants	17.5 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 8 Weeks (including 7 days prior)

Population: Per Protocol Set (PPS) Population: defined as those participants who complied with the study protocol.

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.

Outcome measures

Outcome measures
Measure	Rabeprazole 10 mg n=77 Participants Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.	Rabeprazole 20 mg n=76 Participants Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.	Rabeprazole 40 mg n=74 Participants Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.	Placebo n=80 Participants Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
Rate of Satisfactory Symptom Relief DSQ (n=76, n=75, n=74, n=78)	42.1 Percentage of participants	45.3 Percentage of participants	39.2 Percentage of participants	28.2 Percentage of participants
Rate of Satisfactory Symptom Relief Diary Recordings (n=77, n=76, n=74, n=80)	37.7 Percentage of participants	48.7 Percentage of participants	39.2 Percentage of participants	30.0 Percentage of participants
Rate of Satisfactory Symptom Relief Treatment Success (n=76, n=75, n=74, n=78)	72.4 Percentage of participants	85.3 Percentage of participants	64.9 Percentage of participants	59.0 Percentage of participants

Adverse Events

Rabeprazole 10 mg

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Rabeprazole 20 mg

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Rabeprazole 40 mg

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rabeprazole 10 mg n=85 participants at risk Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.	Rabeprazole 20 mg n=85 participants at risk Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.	Rabeprazole 40 mg n=83 participants at risk Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.	Placebo n=85 participants at risk Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
Gastrointestinal disorders Abdominal Distension	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	1.2% 1/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	1.2% 1/83 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	1.2% 1/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.

Other adverse events

Additional Information

Yoshiumi Okubo, Study Director

Eisai Inc.

Phone: +81-3-3817-3908

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Rabeprazole 10 mg n=85 participants at risk Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.	Rabeprazole 20 mg n=85 participants at risk Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.	Rabeprazole 40 mg n=83 participants at risk Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.	Placebo n=85 participants at risk Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
Gastrointestinal disorders Diarrhoea	3.5% 3/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	3.5% 3/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	2.4% 2/83 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	2.4% 2/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.
Gastrointestinal disorders Enterocolitis	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	2.4% 2/83 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.
Gastrointestinal disorders Periodontitis	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	0.00% 0/83 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	2.4% 2/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.
Gastrointestinal disorders Stomatitis	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	3.6% 3/83 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	1.2% 1/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.
Infections and infestations Gastroenteritis	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	3.5% 3/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	0.00% 0/83 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.
Infections and infestations Gastroenteritis Viral	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	2.4% 2/83 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.
Infections and infestations Nasopharyngitis	11.8% 10/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	8.2% 7/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	18.1% 15/83 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	4.7% 4/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.
Infections and infestations Pharyngitis	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	1.2% 1/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	1.2% 1/83 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	3.5% 3/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.
Investigations Aspartate Aminotransferase Increased	2.4% 2/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	1.2% 1/83 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.
Investigations Blood Triglycerides Increased	3.5% 3/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	0.00% 0/83 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	2.4% 2/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.
Musculoskeletal and connective tissue disorders Back Pain	3.5% 3/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	0.00% 0/83 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	4.7% 4/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.
Nervous system disorders Headache	3.5% 3/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	3.5% 3/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	1.2% 1/83 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Inflammation	2.4% 2/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	2.4% 2/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	1.2% 1/83 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	2.4% 2/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.
Skin and subcutaneous tissue disorders Eczema	1.2% 1/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	2.4% 2/83 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	0.00% 0/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.
Skin and subcutaneous tissue disorders Urticaria	1.2% 1/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	1.2% 1/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	1.2% 1/83 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.	2.4% 2/85 • Up to 8 weeks Safety Analysis Set was defined as those participants who received at least one dose of study drug (N= 338). One participant was incorrectly assigned to a different dose group.