Metformin Safety and Efficacy in Osteoarthritis.

NCT06231758 | Recruiting Phase 3

• 1 other identifier: Menofya 1247
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Outcome Measures will be the change of WOMAC Osteoarthritis Index from baseline to posttreatment

  3 months

Study Arms (2)

control group

ACTIVE COMPARATOR

35 patients will receive celecoxib 200 mg capsule plus placebo tablets

Drug: Celecoxib 200mg

Comparative group

ACTIVE COMPARATOR

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

Drug: Celecoxib 200mg; Drug: Metformin

Interventions

Celecoxib 200mg DRUG

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.

Comparative group; control group

Metformin DRUG

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

Comparative group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mostafa Bahaa: lead

Study Sites (1)

Mostafa Bahaa

Damietta, New Damietta, 34518, Egypt

RECRUITING

MeSH Terms

Interventions

Celecoxib; Metformin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Central Study Contacts

Mostafa Bahaa

CONTACT

+201025538337; mbahaa@horus.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Teaching assisstant

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: January 30, 2024
• Study Start: January 30, 2024
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 20, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

EG (1)