A Phase 4 interventional study of Colchicine 0.5 MG and Placebo in Osteoarthritis Hand and Osteoarthritis Finger, sponsored by Henning Bliddal. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-15.
Sponsored by Henning Bliddal · Phase 4, Interventional, and Treatment
The study aims to compare oral colchicine 0.5 mg administered two times daily for 12 weeks with placebo as a treatment of hand OA symptoms.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 100 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Henning Bliddal is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Comorbidities
Any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as e.g. psychiatric disorders.
Medical history
Planning to start other treatment for hand OA in the study participation period.
Reproductive system
A target hand will be selected for outcome assessment once individual fulfills in- and exclusions criterias. Selection of the target hand will adhere to the following, with advancement to next step if unable to choose target hand based on the given criteria.
Tablet colchicine 0.5 mg administered two times daily
Drug: Colchicine 0.5 MG
Tablet placebo administered two times daily
Drug: Placebo
The intervention tablets are commercially available Colchicine "Tiofarma"
Encapsulated placebo tablets. Placebo is identical to the active intervention.
Finger pain
To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, on changes in finger joint pain of the target hand from baseline to week 12, in patients with painful hand OA measured on a visual analogue scale spanning from 0 to 100, where 0 equals no symptoms and 100 equals worst imaginable symptoms.
Time frame: Week 12
Function
To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in function of both hands measured on the Australian/Canadian Hand Index Function Score spanning from 0 to 900, where higher scores equals worse function.
Time frame: Week 12
Thumb base pain
To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in thumb base pain of the target hand measured on a visual analogue scale spanning from 0 to 100, where 0 equals no symptoms and 100 equals worst imaginable symptoms.
Time frame: Week 12
Pain hands
To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in pain of both hands measured on the Australian/Canadian Hand Index Pain Score spanning from 0 to 500, where higher scores equals worse pain.
Time frame: Week 12
Joint activity
To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in joint activity of the target hand measured on physician tender joint count
Time frame: Week 12
Patient global assessment
To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in patient global assessment measured on a visual analogue scale spanning from 0 to 100, where 0 equals no symptoms and 100 equals worst imaginable symptoms.
Time frame: Week 12
Quality of life measured by European Quality of Life 5 Dimensions
To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in quality of life measured on the European Quality of Life 5 Dimensions spanning from -0.624 to 1.000, where higher scores equals better quality of life.
Time frame: Week 12
Hand strength
To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in hand strength of the target hand measured on grippit
Time frame: Week 12
Number of treatment responders according to OMERACT-OARSI response criteria
The following two conditions is observed at the post-baseline assessment: 1. In either pain (finger pain) or function (function), a high improvement in the subscale, where high improvement in a subscale is achieved if there is both a \> 50% improvement from Baseline and an absolute change from Baseline of \> 20 percent points (0-100 scale), OR 2. Improvement in at least two of the following three: * Improvement in pain (finger pain) defined as \> 20% improvement from Baseline and an absolute change from Baseline of \> 10 points (0-100 scale) * Improvement in function (function) defined as \> 20% improvement from Baseline and an absolute change from Baseline of \> 10 points (0-100 scale) * Improvement in patient's global assessment defined as \> 20% improvement from Baseline and an absolute change from Baseline of \> 10 mm (0-100 scale)
Time frame: Week 12
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Plan to share: Undecided
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Henning Bliddal