UMIN-CTR Clinical Trial

Public title

Randomized controlled trial to determine the efficacy and safety of ramosetron hydrochloride in male patients with diarrheal-predominant IBS symptom

Acronym

Randomized controlled trial of the effect of ramosetron hydrochloride on IBS symptom

Scientific Title

Randomized controlled trial to determine the efficacy and safety of ramosetron hydrochloride in male patients with diarrheal-predominant IBS symptom

Scientific Title:Acronym

Randomized controlled trial of the effect of ramosetron hydrochloride on IBS symptom

Region

Japan

Condition

Irritable bowel syndrome

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the effect of ramosetron hydrochloride and trimebutine maleate in male patients with diarrheal-predominant IBS symptom, VAS and IBS-QOL at 4 week are investigated. Blood cytokine level is also determined as a biomarker for the objective evaluation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

IBS-QOL-J

Key secondary outcomes

1.Subjective symptom (abdominal pain, abdominal fullness)
2.Defecation (bowel frequency, stool form)
3. Blood cytokine level
4.Serum concentration of serotonin
5.Patient's impression

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

1. Test drug for 4 weeks -> control drug for 4 weeks
After oral administration of test drug (ramosetron hydrochloride) 5 maicro;g/dose once a day for 4 weeks, control drug (trimebutine maleate) 100 mg/dose three times a day is administered orally for 4 weeks.

Interventions/Control_2

ikuro;2. Control drug for 4 weeks -> test drug for 4 weeks
After oral administration of control drug (trimebutine maleate) 100 mg/dose three times a day for 4 weeks, test drug (ramosetron hydrochloride) 5 maicro;g/dose once a day is administered orally for 4 weeks.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male

Key inclusion criteria

1. Selection criteria at the time obtain informed consent (at interim admission)
1) Patients who are diagnosed as diarrheal-predominant IBS by Rome III criteria.
2) Patients aged 20 or over at the time obtain informed consent.
3) Gender: male.
4) Consultation method: no specification
5) Patients who can provide the written informed consent.

2. Selection criteria at the time admission to the study.
1) Patients who discontinue use of any IBS medication at least 7 days prior to admission to the study.
2) Patients who wrote daily report of IBS symptom 7 days prior to admission to the study.

Key exclusion criteria

1) Patients who have bowel move disturbance by organic lesion such as IBD(UC and crohn disease etc.) and cancer.
2) Patients suspected of obstruction in stomach and intestines, and with a history of total gastric resection or bowel resection but not appendicectomy
3) Patients with serious complications (liver, kidney, heart, lung, circulatory, or metabolic disorder)
4) Patients with a history of drug allergy
5) Patients who are taking psychotropic drug
6) Others, including patients who are unfit for the study as determined by the attending doctor

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Ryoichi Takayanagi

Organization

Kyushu University Hospital

Division name

Department of Hepatology and Pancreatology

Zip code

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka

TEL

092-642-5100

Email

Name of contact person

1st name
Middle name
Last name	Kazuhiko Nakamura

Organization

Kyushu University Hospital

Division name

Department of Hepatology and Pancreatology

Zip code

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka

TEL

Homepage URL

Email

Institute

Department of Hepatology and Pancreatology, Kyushu University Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

済生会福岡総合病院（福岡県）
麻生飯塚病院（福岡県）
福岡市民病院（福岡県）
福岡東医療センター（福岡県）
九州医療センター（福岡県）
別府医療センター（福岡県）
北九州市立医療センター（福岡県）

Date of disclosure of the study information

2011

Year

05

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2011

Year

04

Month

01

Day

Date of IRB

Anticipated trial start date

2011

Year

06

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

03

Month

11

Day

Last modified on

2011

Year

03

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006221