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

Plain English Summary

Metformin Safety and Efficacy in Osteoarthritis. is a Phase 3 clinical trial sponsored by Mostafa Bahaa studying Osteo Arthritis Knee. Tests if Metformin can reduce pain in knee osteoarthritis. For adults aged 30-60 with knee pain and X-ray confirmed arthritis. Participation involves taking Metformin and Celecoxib for 3 months. Alternatives include other pain medications and lifestyle changes. The trial aims to enroll 70 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Ages 30-60, X-ray confirms knee arthritis, no other severe health issues. Cannot have active stomach or liver problems, no other joint issues, no recent steroid use. This trial is studying Osteo Arthritis Knee, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

Measures how much pain is reduced, helping patients manage knee pain better. The specific primary outcome measures are: The primary efficacy end point will be the change of Visual Analogue Scale (VAS) pain score from baseline to post treatment. (3 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial aims to fill the gap in treatments that can slow knee osteoarthritis progression. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Osteo Arthritis Knee, where improved treatment options are needed.

Investor Insight

Market size is large, with many patients seeking effective treatments, approval likely. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if you have knee pain and X-ray confirmed arthritis. Take Metformin and Celecoxib daily for 3 months, and report any side effects. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 70 participants

Interventions

• 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.
• DRUG: 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

Primary Outcomes

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

Secondary Outcomes

• Secondary Outcome Measures will be the change of WOMAC Osteoarthritis Index from baseline to posttreatment (3 months)

Full Eligibility Criteria

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.

Trial Locations

• Mostafa Bahaa, Damietta, New Damietta, Egypt

Frequently Asked Questions

Related Conditions

• Knee osteoarthritis, joint pain, pain management, anti-inflammatory drugs

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