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Alkaloid
Revisiting the Mechanism of the Anti-inflammatory Effect of Colchicine
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
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 • NCT043551434%
GI discomfort
100%
80%
60%
40%
20%
0%
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
~2420
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,668 Previous Clinical Trials
11,876,304 Total Patients Enrolled
Harvard Medical School (HMS and HSDM)OTHER
204 Previous Clinical Trials
1,316,471 Total Patients Enrolled
Lindsey Baden, MDPrincipal InvestigatorBrigham and Women's Hospital
7 Previous Clinical Trials
947 Total Patients Enrolled