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Metformin Safety and Efficacy in Osteoarthritis.

Recruiting
30 - 60 years of age
Both
Phase 3

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Overview

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

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.

Study details

Osteo Arthritis Knee

NCT06231758

Mostafa Bahaa

16 February 2024

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