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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000005237
Receipt No. R000006221
Scientific Title Randomized controlled trial to determine the efficacy and safety of ramosetron hydrochloride in male patients with diarrheal-predominant IBS symptom
Date of disclosure of the study information 2011/05/01
Last modified on 2011/03/11

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Basic information
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
Condition Irritable bowel syndrome
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Department of Hepatology and Pancreatology, Kyushu University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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)

Other administrative information
Date of disclosure of the study information
2011 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date
2011 Year 03 Month 11 Day
Last modified on
2011 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006221

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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