A multi-center exploratory study to evaluate the efficacy of colchicine in inflammatory bowel disease

UMIN ID: UMIN000054655

Registered date:17/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Inflammatory bowel disease
• Date of first enrollment: 2024/06/06
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Proportion of patients with a clinical response by Patient-Reported Outcome 2 (PRO2) score 14 days after colchicine treatment

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Sapporo Medical University
• Source(s) of Monetary Support: None
• Secondary ID(s): jRCTs061240020