Metformin Treatment of Patients with Hand Osteoarthritis

ConditionHand Osteoarthritis

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorMarius Henriksen

About this trial

To compare metformin (2 g daily), or maximum tolerated dose, for 16 weeks with placebo as a treatment of hand osteoarthritis symptoms.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Hand OA according to the ACR criteria

Average finger (2 to 5) pain ≥4 on a 0-10 numeric rating scale (NRS where 10 is worst pain) over the past 30 days

Metformin naive

Disqualifiers

History of, or current signs of medical disease that may affect joints, e.g. rheumatoid arthritis, gout, psoriatic arthritis

Psoriasis

Known malignancy (except successfully treated squamous or basal cell skin carcinoma)

Drug or alcohol abuse in the last year

Trial design

Design model

Parallel

Treatments tested in this trial

Metformin
Drug
Metformin will be initiated at 500 mg once daily with breakfast meal. The dose will be increased with 500 mg every week until 2 g/day is reached, distributed as 1000 mg every morning and evening, together with a meal. If the subject cannot tolerate the maximum dose (2 g/day), the maximal tolerated dose will be given. The treatment period including titration is 16 weeks.
Placebo
Drug
Participants in the placebo group will receive a placebo tablet identical to the metformin tablet

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: MetforminExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Finger pain

Change from baseline in Visual Analogue Scale (VAS) finger joint pain of the target hand after 16 weeks of treatment

Time frame

Week 16

Secondary outcomes

Function

Change from baseline after 16 weeks of treatment in physical function assessed by Australian/Canadian Osteoarthritis Hand Index (AUSCAN) physical function subscale

Time frame

Week 16

Thumb base pain

Change from baseline after 16 weeks of treatment in Visual Analogue Scale thumb base pain of the target hand

Time frame

Week 16

Hand pain

Change from baseline after 16 weeks of treatment in pain of both hands assessed by Australian/Canadian Osteoarthritis Hand Index hand pain subscale

Time frame

Week 16

Physician tender joint count

Change from baseline after 16 weeks of treatment in joint activity of the target hand assessed by physician tender joint count

Time frame

Week 16

Other outcomes

Stiffness of both hands

Change in stiffness of both hands measured on the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) stiffness subscale

Time frame

Week 16

Composite of pain, function and stiffness

Change in pain, function and stiffness of both hands measured composite on the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) Hand Index Score

Time frame

Week 16

Physical function

Change in physical function of both hands assessed by the Health Assessment Questionnaire Disability Index (HAQ-DI)

Time frame

Week 16

Physician global assessment

Change in physician global assessment of disease activity of hand OA in the target hand measured on a Visual Analogue Scale (VAS) scale

Time frame

Week 16

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marius Henriksen

Lead sponsor

Frederiksberg University Hospital

Sponsor institution

Source ClinicalTrials.gov

Apply now