Colchicine 0.8 mg or 0.6 mg orally once daily for Arthrosis

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Arthrosis+2 More
Colchicine 0.8 mg or 0.6 mg orally once daily - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether colchicine may help individuals with knee osteoarthritis.

Eligible Conditions
  • Arthrosis
  • Knee

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 3 Months

3 Months
Difference in mean changes of VAS pain scores between treatment groups
Mean changes and absolute differences in the Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain
mean absolute doses and changes in dosage of acetaminophen or other medications used for pain between and within the groups at baseline and 3 months.
mean changes between total KOOS scores between and within the groups at 3 months.
mean changes of KOOS physical function
mean changes of KOOS stiffness

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Colchicine
1%Chest pain
1%Ischemic stroke
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT01709981) in the Colchicine ARM group. Side effects include: Chest pain with 1%, Ischemic stroke with 1%.

Trial Design

2 Treatment Groups

Colchicine
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

120 Total Participants · 2 Treatment Groups

Primary Treatment: Colchicine 0.8 mg or 0.6 mg orally once daily · Has Placebo Group · Phase 4

Colchicine
Drug
Experimental Group · 1 Intervention: Colchicine 0.8 mg or 0.6 mg orally once daily · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo oral capsule · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,253 Previous Clinical Trials
743,702 Total Patients Enrolled
Michael H Pillinger, MD, FACPPrincipal InvestigatorNYU Langone Health

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
These patients have an approximate glomerular filtration rate that is more than 30 milliliters per minute and liver transaminases that are less than two times the upper limit of normal.
You may continue to have frequent knee problems, as defined above.
Participants will be asked to have a knee radiograph (X-ray of the knee) done within the past 6 months, if they have not already done so.
The person must have a BMI of less than or equal to 32 at the time of enrollment.
I agree to take either colchicine or a placebo every day for three months.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: November 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Pennsylvania50.0%
Arizona50.0%
How old are they?
18 - 6550.0%
65+50.0%
What site did they apply to?
NYU Langone Health100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Email100.0%