Metformin Safety and Efficacy in Osteoarthritis.

Mostafa Bahaa

Status and phase: Enrolling; Phase 3

Conditions: Osteo Arthritis Knee

Treatments: Drug: Metformin; Drug: Celecoxib 200mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06231758

Menofya 1247

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

Patients with age less than 30 years or more than 60 years Patients Presented with active concomitant gastroduodenal disorders, hepatic and renal impairment within last 30 days prior to receiving the study drug Patients Were diagnosed to have any inflammatory arthritis, gout or acute trauma of the knee, hip or spine; accompanying OA of the hip of sufficient severity to interfere with the functional assessment of the knee Patients had previous or ongoing treatment with oral SYSDOA (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics; were having active cardiac lesion or hypertension, were pregnant females and those who were planning their pregnancy during the study Patients having a known hypersensitivity to the used medications Patients have persistent diarrhoea or laxative use; severe gastrointestinal disorders, severe obesity, severe parenchymal organ disease, or anaemia (haemoglobin< 10.0 g/ dl or haematocrit < 30%).

Patients who received oral, intramuscular, intraarticular or soft tissue injections of corticosteroids within last eight weeks before receiving the first dose of the study medication or had undergone joint lavage and arthroscopic procedures in the previous 6 months, were also excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

control group

Active Comparator group

Description:

35 patients will receive celecoxib 200 mg capsule plus placebo tablets

Treatment:

Drug: Celecoxib 200mg

Comparative group

Active Comparator group

Description:

35 patients will receive celecoxib 200 mg capsule plus 1000 mg metformin daily

Treatment:

Drug: Celecoxib 200mg

Drug: Metformin