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Alkaloid

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
Awards & highlights

Study 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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Plasma GDF15 levels

Side effects data

From 2021 Phase 2 trial • 93 Patients • NCT04355143
4%
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
~2450

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
1,609 Previous Clinical Trials
11,470,309 Total Patients Enrolled
Harvard Medical School (HMS and HSDM)OTHER
195 Previous Clinical Trials
1,316,027 Total Patients Enrolled
Lindsey Baden, MDPrincipal InvestigatorBrigham and Women's Hospital
7 Previous Clinical Trials
947 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any prior studies involving the effectiveness of Colchicine Tablets?

"Currently, 31 Colchicine Tablet trials are underway with 12 of them in their third phase. Even though most of the studies are based around New york City, a total of 98 sites across the globe have launched investigations into this medication's efficacy."

Answered by AI

What criteria must an individual meet to be eligible for this research?

"The requirements for acceptance into this clinical trial include being between 18 and 50 years old, as well as having a demonstrated understanding of colchicine's action. A total of 18 individuals will be accepted to the study."

Answered by AI

What potential hazards accompany the consumption of Colchicine Tablets?

"Our team at Power assigned Colchicine Tablets a score of 1 on the safety scale due to this being an early-stage clinical trial, with limited evidence in support of its efficacy and security."

Answered by AI

Has the recruitment process for this experiment begun?

"Affirmative. Clinicaltrials.gov contains data indicating that this clinical trial is currently seeking participants, which were initially posted on May 6th 2020 and last updated on March 14th 2022. The study necessitates 18 volunteers from a single centre to be recruited."

Answered by AI

How many participants are currently engaged in this research project?

"Affirmative. According to information hosted on clinicaltrials.gov, this medical investigation is actively searching for individuals to participate. Initially posted on the 6th of May 2020 and updated as recently as 14th March 2022, 18 participants are required at a single site."

Answered by AI

What conditions typically warrant treatment with Colchicine Tablets?

"Colchicine Tablets are typically prescribed to manage gout flares, but they also have value in treating familial mediterranean fever and postcommissurotomy syndrome as well as behcet's syndrome."

Answered by AI

Is this experimental research open to participants of all ages, or is there an upper age limit?

"Individuals aged 18 to 50 are eligible for this clinical trial; those younger or older must join one of the 33 other trials tailored specifically to their age bracket."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Revisiting the Mechanism of the Anti-inflammatory Effect of Colchicine
Lindsey R. Baden, MD 2020. "Revisiting the Mechanism of the Anti-inflammatory Effect of Colchicine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04355585.
~4 spots leftby Apr 2025
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