Inflammatory bowel disease Inflammatory bowel disease
Conditions
Interventions
Colchicine taken orally
Sponsors
Nakase Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with a clinical response by Patient-Reported Outcome 2 (PRO2) score 14 days after study drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with clinical response by PRO2 score 14 days after study drug administration for each UC and CD Proportion of patients with clinical response by partial Mayo score or Harvey Bradshaw index after 14 days after study drug administration Proportion of patients with clinical response by PRO2 score 14 days after increasing the dose of the study drug (28 days after starting the study drug) Proportion of patients with clinical remission by PRO2 score and partial Mayo score or HBI at 28, 56, and 84 days after study drug administration Proportion of patients with endoscopic remission 84 days after study drug administration Proportion of patients with improvement in extraintestinal complications after study drug administration Association between patient background and therapeutic efficacy of the study drug Safety Exploration of predictive factors for efficacy of study drug using multi-omics analysis | — |
Contacts
Public ContactHiroki Kurumi
Sapporo medical university school of medicine
Outcome results
None listed