Effect of Metformin as Add-on Therapy to Ibuprofen on Disease Activity in Knee Osteoarthritis Patients.

NCT06126029 | Unknown Phase 2

• 1 other identifier: BSMMU/2023/11020
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized, double blind, placebo-controlled clinical trial is to learn about, the effect of metformin compared with placebo-controlled group on disease activity and interleukin-6 level in patients with knee osteoarthritis.The main question it aims to answer is:Is Metformin as add-on therapy more effective in reducing disease activity in Ibuprofen-treated patients with grade II-III knee osteoarthritis? Half of Participants will receive metformin with standard of care(ibuprofen and rabeprazole) while other half placebo and standard of care (ibuprofen and rabeprazole).

Conditions

Knee Osteoarthritis; Metformin

Outcome Measures

Primary Outcomes (1)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  The KOOS meets basic criteria of outcome measures and can be used to evaluate the course of knee injury and treatment outcome. KOOS will be used to assess improvements in the scores(out of 100) of five patient-relevant outcomes (pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life) of knee osteoarthritis patients after 8 weeks of intervention.

  1 year

Secondary Outcomes (1)

• Serum Interleukin-6 (IL-6) level

  1 year

Study Arms (2)

Metformin group

EXPERIMENTAL

This group will receive metformin 500mg extended release oral tablet daily along with standard of care for 8 weeks.

Drug: Metformin 500 Mg extended release Oral Tablet

Placebo group

PLACEBO COMPARATOR

This group will receive placebo oral tablet daily along with standard of care for 8 weeks.

Drug: Placebo oral tablet

Interventions

Metformin 500 Mg extended release Oral Tablet DRUG

34 patients of experimental group will get metformin 500mg extended release oral tablet once daily with evening meal along with standard of care (ibuprofen 400mg and rabeprazole 20mg twice daily) for 8 weeks as prescribed by the physician.

Metformin group

Placebo oral tablet DRUG

34 patients of placebo group will get placebo oral tablet once daily with evening meal along with standard of care (ibuprofen 400mg and rabeprazole 20mg twice daily) for 8 weeks as prescribed by the physician.

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with knee pain
• Radiographic evidence of knee osteoarthritis (Grade II-III)
• Age 18-65 years
• Both male and female
• Normal BMI(for asians): 18.5-22.9 kg/m2

You may not qualify if:

• Diagnosed case of Diabetes Mellitus, renal, hepatic, cardiovascular or pulmonary disease
• Diagnosed case of Gout or pseudogout
• Diagnosed case of systemic inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease
• Patients currently receiving immunosuppressant, carbonic anhydrase inhibitors(topiramate), ranolazine, vandetanib, dolutegravir
• History of receiving a corticosteroid injection in the last three months
• Prior history of knee trauma or surgery
• Metformin use or history of use in the last two months
• Known allergy to metformin
• History of lactic acidosis
• Patient with habit of excessive alcohol intake
• Pregnancy
• Patients unwilling to participate or unwilling to give written consent
• Participation in another clinical trial

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1000, Bangladesh

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Metformin

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Md.Delowar Hossain, MD

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Md.Delowar Hossain, MD

CONTACT

+8801675369860; delowar650@gmail.com

Dr.Swapan Kumar Tapader

CONTACT

88029661064; registrar@bsmmu.edu.bd

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: October 15, 2023
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

BA (1)