UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054655 |
|---|---|
| Receipt number | R000062420 |
| Scientific Title | A multi-center exploratory study to evaluate the efficacy and safety of colchicine in patients with inflammatory bowel disease |
| Date of disclosure of the study information | 2024/06/17 |
| Last modified on | 2024/06/13 16:50:55 |
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Basic information
Public title
A multi-center exploratory study to evaluate the efficacy of colchicine in inflammatory bowel disease
Acronym
MUSE study
Scientific Title
A multi-center exploratory study to evaluate the efficacy and safety of colchicine in patients with inflammatory bowel disease
Scientific Title:Acronym
MUSE study
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study is to examine the efficacy and safety of colchicine in patients with mild to moderate inflammatory bowel disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients with a clinical response by Patient-Reported Outcome 2 (PRO2) score 14 days after colchicine treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Colchicine will be started at 0.5 mg/day. If clinical response is achieved on Day 14, colchicine is administered until Day 84. If clinical response is not achieved on Day 14 after initiation of colchicine, the dose of colchicine is increased to 1.0 mg/day and clinical response is assessed again on Day 28. If clinical response is achieved on Day 28, patients receive colchicine at 1.0 mg/day until Day 84. If clinical response is not achieved on Day 28, colchicine is discontinued.
Interventions/Control_2
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with mild or moderate IBD who are untreated or non-responsive or intolerant to treatment with 5-ASA
Patients 16 years and older
Patients with preserved function of major organs such as heart, lungs, liver, and kidneys.
Patients who have obtained written consent from the study subjects themselves. In the case of minors, consent must also have been obtained from a surrogate.
Key exclusion criteria
Patients who have received treatment for IBD other than 5-ASA within the previous month.
Patients with liver or kidney damage who are taking drugs that inhibit the hepatic metabolic enzyme CYP3A4 or P-glycoprotein.
Patients whose dosage, administration, or formulation of 5-ASA has been changed within 2 weeks prior to the administration of the study drug.
Patients with bleeding tendency or on antithrombotic drugs
Patients with cancer
Patients with hypersensitivity to colchicine
Patients with serious infections
Patients taking other study drugs.
Pregnant or lactating women, or women of childbearing potential.
Patients deemed ineligible by the principal investigator or subinvestigator of the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nakase |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8543
Address
S-1, W-16, Chuoku, Sapporo, Hokkaido
TEL
011-611-2111
hiropynakase@gmail.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Kurumi |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8543
Address
S-1, W-16, Chuoku, Sapporo, Hokkaido
TEL
011-611-2111
Homepage URL
kurumi_1022_1107@yahoo.co.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
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
Certified Review Board, Tottori University Hospital
Address
36-1 Nishi-cho, Yonago, Tottori
Tel
0859-38-7021
cert.office@ml.med.tottori-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs061240020
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 13 | Day |
Last modified on
| 2024 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062420
