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Revisiting the Mechanism of the Anti-inflammatory Effect of Colchicine

NCT04355585 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-03-16

No results posted yet for this study

Summary

We are doing this research study to better understand the mechanism of action of colchicine, a drug commonly prescribed for gout. Precisely, we aim to evaluate the effect of colchicine on a specific protein (GDF15) blood levels at different timepoints after its administration.

This research study will compare GDF15 blood levels after the administration of colchicine or placebo. The placebo looks exactly like colchicine but contains no active drug. During this study, participants may get a placebo instead of colchicine. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons.

Conditions

  • Colchicine Mechanism of Action

Interventions

DRUG

Colchicine Tablets

1.8mg of Colchicine given over 1 hour (1.2 mg followed by 0.6 mg 1 hour later)

DRUG

Placebo oral tablet

Placebo given over 1 hour (first tablet followed by second tablet 1 hour later)

Sponsors & Collaborators

  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Lindsey Baden, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-06
Primary Completion
2023-04-30
Completion
2023-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04355585 on ClinicalTrials.gov