Metformin Safety and Efficacy in Osteoarthritis.

ConditionOsteo Arthritis Knee

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age30-60

SponsorMostafa Bahaa

About this trial

Knee osteoarthritis (OA) is a chronic, painful disease associated with considerable morbidity, costs and disability. It is estimated that over a third of people aged over 60 have radiographic knee OA2 and over 50% of these with knee OA will go on to have a total knee replacement in their lifetime. At present there are no licensed treatments that alter disease progress and management is primarily concerned with symptom control to retain or improve joint function, although a trial of strontium ranelate showed promising results.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary osteoarthritis Patients recruited were between 30 to 60 years of age.

X-ray confirmed Kellgren-Lawrence grade II or III severity primary tibiofemoral OA according to the American College of Rheumatology criteria.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Celecoxib 200mg
Drug
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis (eg, osteoarthritis, rheumatoid arthritis, or juvenile rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain.
Metformin
Drug
Metformin (MET), a traditional antdiabetic drug, exerts glucose-lowering effect by activating AMPK since it is a critical enzyme in lipid and glucose metabolism

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: control groupActive comparator 1 intervention

Group B: Comparative groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

The primary efficacy end point will be the change of Visual Analogue Scale (VAS) pain score from baseline to post treatment.

The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.

Time frame

3 months

Secondary outcomes

Secondary Outcome Measures will be the change of WOMAC Osteoarthritis Index from baseline to posttreatment

Self-administered Western Ontario and McMaster Universities (WOMAC) index is the most common used clinical tools for evaluating patients with knee OA. It includes five questions about pain, two about stiffness, and 17 on degree of disability of activities of daily living.

Time frame

3 months

Sponsors and contacts

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

Mostafa Bahaa

Lead sponsor

Tanta University

Sponsor institution

Source ClinicalTrials.gov

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