Metformin Safety and Efficacy in Osteoarthritis.

Osteo Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06231758
• Other study ID #: Menofya 1247
• Status: Recruiting
• Phase: Phase 3
• Start date: January 30, 2024
• Est. completion date: September 20, 2027

Study information

• Verified date: January 2024
• Source: Tanta University
• Contact: Mostafa Bahaa
• Phone: +201025538337
• Email: mbahaa[@]horus.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 20, 2027
• Est. primary completion date: January 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

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.

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• 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.
• 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

Locations

Country	Name	City	State
Egypt	Mostafa Bahaa	Damietta	New Damietta

Sponsors (1)

Lead Sponsor	Collaborator
Mostafa Bahaa

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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.	3 months