Adults 18 to 99, any sex, with Osteoarthritis or Osteo Arthritis Knee. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Visual Analog Scale (VAS) Pain ScorePrimary· Baseline, 3 Months
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Group
Value
95% CI
Placebo
-1.45
± 2.45
Colchicine
-1.16
± 2.22
Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain ScoreSecondary· Baseline, 3 Months
The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms/stiffness (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The KOOS Pain Score refers to a specific subscale within the KOOS questionnaire that measures the severity of knee pain experienced by a patient, consisting of nine questions where each response is scored on a scale from 0 (no pain) to 4 (extreme pain), with a higher score indicating greater pain intensity; the overal
Group
Value
95% CI
Placebo
9.5
± 20
Colchicine
5.2
± 19
Change in the KOOS Stiffness ScoreSecondary· Baseline, 3 Months
The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms/stiffness (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). Each item on the KOOS is scored on a scale from 0 (no problems) to 4 (extreme problems), and then the scores are calculated to generate a final score between 0 and 100. The KOOS stiffness score is a percentage from 0 to 100 that measures how much stiffness a patient experiences in their knee. A score of 0 indicates th
Group
Value
95% CI
Placebo
6.6
± 15.7
Colchicine
5.5
± 19.1
Change in the KOOS Physical Function ScoreSecondary· Baseline, 3 Months
The KOOS's five patient-relevant dimensions are scored separately: Pain (9 items); Symptoms/Stiffness (7 items); Function, Daily Living (17 items); Function, Sports and Recreational Activities (5 items); Quality of Life (4 items). The KOOS Physical Function items are scored on a Likert scale from 0 to 4, with 0 indicating no problems and 4 indicating extreme problems. The scores for each dimension are then transformed to a scale from 0 to 100, where 0 represents extreme problems with knee function and 100 indicates no problems at all.
Group
Value
95% CI
Placebo
9.8
± 17.6
Colchicine
7.4
± 17.5
Change in the KOOS Quality of Life ScoreSecondary· Baseline, 3 Months
The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms/stiffness (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). A KOOS Quality of Life score ranges from 0 to 100, where 0 represents the worst possible knee-related quality of life and 100 indicates no problems at all. A higher score indicates better quality of life related to the knee.
Group
Value
95% CI
Placebo
6.9
± 22
Colchicine
3.5
± 15.8
Change in the KOOS Sports and Recreational ActivitiesSecondary· Baseline, 3 Months
The KOOS's five patient-relevant dimensions are scored separately: Pain (9 items); Symptoms/Stiffness (7 items); Function, Daily Living (17 items); Function, Sports and Recreational Activities (5 items); Quality of Life (4 items). The KOOS Sports and Recreational Activities 9 items are scored on a Likert scale from 0 to 4, with 0 indicating no problems and 4 indicating extreme problems relating to sports and recreational activities. The scores are then transformed to a scale from 0 to 100, with 100 indicating no knee problems with sports and recreational activities and 0 indicating extreme kne
Group
Value
95% CI
Placebo
0.0
± 25.8
Colchicine
2.8
± 19.4
Change in the KOOS Total ScoreSecondary· Baseline, 3 Months
The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms/stiffness (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Group
Value
95% CI
Placebo
6.5
± 20.7
Colchicine
4.9
± 18.1
Number of Participants Who Used Acetaminophen or Other Medications for PainSecondary· 6 weeks
Group
Value
95% CI
Placebo
15
Colchicine
13
Number of Participants Who Used Acetaminophen or Other Medications for PainSecondary· 3 Months
Group
Value
95% CI
Placebo
16
Colchicine
12
Change in Number of Participants Who Used Acetaminophen or Other Medications for PainSecondary· 6 weeks, 3 months
This prospective, double-blinded, placebo-controlled, randomized trial will enroll 120 SKOA subjects at the NYU Center for Musculoskeletal Care. Patients meeting entry criteria will be randomized 1:1 to treatment with colchicine or placebo daily for 3 months. Subjects will have detailed evaluation of standardized clinical pain outcomes, candidate peripheral blood biomarkers, baseline knee radiographs as well as MSK-US, and a subset will undergo evaluation of their synovial fluid.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
Last refreshed: 3 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03913442.