Colchicine Tablets for Colchicine Mechanism of Action

Phase 1

Waitlist Available

Led By Lindsey Baden, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before product administration and 2, 4, 6 ,8, 10,12, 24 and 48 hours after product administration

Summary

This trial will help researchers understand if colchicine affects the blood levels of GDF15, a protein that is linked with gout.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before product administration and 2, 4, 6 ,8, 10,12, 24 and 48 hours after product administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before product administration and 2, 4, 6 ,8, 10,12, 24 and 48 hours after product administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and before product administration and 2, 4, 6 ,8, 10,12, 24 and 48 hours after product administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Plasma GDF15 levels

Side effects data

From 2021 Phase 2 trial • 93 Patients • NCT04355143

GI discomfort

100%

80%

60%

40%

20%

Study treatment Arm

Colchicine Plus Current Care

Current Care Alone

Trial Design

2Treatment groups

Experimental Treatment

Group I: MaleExperimental Treatment2 Interventions

Participants in this group will be randomized to receive either a single dose of colchicine (1.8mg administered over 1 hour in the form of tablets) or placebo.

Group II: FemaleExperimental Treatment2 Interventions

Participants in this group will be randomized to receive either a single dose of colchicine (1.8mg administered over 1 hour in the form of tablets) or placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Colchicine Tablets

2020

Completed Phase 3

~550

Placebo oral tablet

2019

Completed Phase 4

~2430