Metformin Safety and Efficacy in Osteoarthritis.
Key facts
- Who runs it
- Mostafa Bahaa
- Where
- Damietta, EgyptSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 70 people, planned
- Started
- 30 Jan 2024
- Expected to end
- 20 Nov 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Celecoxib 200mg
- Metformin
- Record updated
- 13 March 2026
Who can take part
- Age
- 30 years to 60 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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%)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 60 years old?
Where in Egypt
- Mostafa BahaaDamietta, EgyptContact: Mostafa Bahaa, PhDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- control groupExisting treatment, for comparison
35 patients will receive celecoxib 200 mg capsule plus placebo tablets
Treatment: Celecoxib 200mg
- Comparative groupExisting treatment, for comparison
35 patients will receive celecoxib 200 mg capsule plus 1000 mg metformin daily
Treatment: Celecoxib 200mg and Metformin
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Patients With Knee Osteoarthritis
- Fit questions
- Built from NCT06231758, who can take part
- Publications
- Record updated
- 13 March 2026