Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Comorbidities
Other known medical disease that may affect joints, e.g. RA, gout, PsA
Positive anti-cyclic citrullinated peptide (>10 kU/L)
Known cutaneous deposition diseases (e.g. amyloidosis or porphyria).
Known blood dyscrasias and coagulation disorders
Known malignancy (except successfully treated squamous or basal cell skin carcinoma)
Elevated alanine transaminase (>45 U/L females, >70 U/L for males)
Creatinine clearance ≤60 ml/min
Elevated creatine kinase (>210 U/L females, >280 U/L for males)
Known allergies towards the interventions
Drug or alcohol abuse in the last year
Generalised pain syndromes such as fibromyalgia
Current reflux
Current or recurrent diarrhoeal illnesses
Current abdominal pain
Known peripheral neuropathies
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
History of hand surgery within 12 months prior enrolment.
History of arthroplasty or arthrodesis in the hand Management strategies
Treatment with P-glycoprotein inhibitors and/or cytochrome P450 3A4 (CYP3A4) inhibitors, see section "Colchicine safety in drug-drug interactions" and table 7. If potential participants have been treated with these pharmaceuticals previously, treatment must be terminated 5 half-lifes before initiation of study drug.
Use of systemic corticosteroids equivalent of ≥ 7.5 mg prednisolone daily within 3 months.
Participation in experimental device or experimental drug study 3 months prior to enrolment.
Intra-articular treatments or aspirations of any kind of any joint in the hands 3 months before inclusion
Intra-articular corticosteroids into any joint 1 months before inclusion
Current use of synthetic or non-synthetic opioids
Scheduled surgery during study participation
Planning to start other treatment for hand OA in the study participation period.
Reproductive system
Pregnancy.
Planned pregnancy within the study period, 3 months after end of study treatment for female fertile participant and 6 months after end of study treatment for male participant.
Insufficient anti-conception therapy for female fertile participants within the study period and 3 months after end of study treatment. Sufficient anti-conception therapy consists of intra-uterine device (coil),hormonal anti-conception (birth control pills, implant, intra-uterine system, dermal patch, vaginal ring, or injections) or sexual abstinence Female participants are considered infertile if they are postmenopausal or if they have undergone surgical sterilisation (bilateral salpingectomy, hysterectomy or bilateral oophorectomy). Postmenopausal state is defined as no menses for 12 months without alternative medical cause before inclusion in the study. Menopause state will be confirmed by measurement of follicle stimulating hormone.
Insufficient anti-conception therapy for male participants within the study period and 6 months after end of study treatment. Sufficient anti-conception therapy consists of condom or sexual abstinence. Male participants are considered sterile if they have undergone surgical sterilisation (vasectomy).
Breast-feeding
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.
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal