Metformin Safety and Efficacy in Osteoarthritis.

Официальное название

The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Patients With Knee Osteoarthritis

Обзор

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.

Вмешательства

• Препарат Celecoxib 200mg
  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.
• Препарат Metformin
  Metformin (MET), a traditional antdiabetic drug, exerts glucose-lowering effect by activating AMPK since it is a critical enzyme in lipid and glucose metabolism

Первичные конечные точки

• The primary efficacy end point will be the change of Visual Analogue Scale (VAS) pain score from baseline to post treatment. [Срок оценки: 3 months]

Вторичные конечные точки (1)

• Secondary Outcome Measures will be the change of WOMAC Osteoarthritis Index from baseline to posttreatment [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Mostafa Bahaa — Damietta

Идентификаторы

NCT: NCT06231758 · Menofya 1247

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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