Osteoarthritis Musculoskeletal Diseases Polyarthrosis
Conditions
Interventions
60 subjects randomised into 2 groups (n = 30):
1. Aflapin® (oral) 50 mg twice daily (bid)
2. Placebo
Ibuprofen will be used as a rescue medication for both groups. The study duration is 30 days an
Sponsors
Laila Impex R&D Center (India)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants must understand risks and benefits of the protocol and able to give informed consent 2. Male and female subjects of 40 - 80 years of age 3. Females of child bearing potential must agree to use an approved form of birth control and have a negative pregnancy test result 4. Unilateral or bilateral OA of the knee for more than 3 months 5. Visual Analogue Scale (VAS) score during the most painful knee movement between 40 - 70 mm after 7 day withdrawal of usual medication 6. Lequesne's Functional Index (LFI) score greater than 7 points after 7 days of withdrawal of usual medication 7. Ability to walk 8. Availability for the duration of the entire study period
Exclusion criteria
Exclusion criteria: 1. History of underlying inflammatory arthropathy or severe rheumatoid arthritis (RA) 2. Hyperuricemia (greater than 440 umol/L) and/or past history of gout 3. Recent injury in the area affected by OA of the knee (past 4 months) and expectation of surgery in the next 4 months 4. Intra-articular corticosteroid injections within the last 3 months 5. Hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), abnormal liver or kidney function tests, history of peptic ulceration and upper gastrointestinal (GI) haemorrhage, congestive heart failure, hypertension, hyperkalemia 6. Major abnormal findings on complete blood count, history of coagulopathies, haematological or neurological disorders 7. High alcohol intake (greater than 2 standard drinks per day) 8. Pregnant, breastfeeding or planning to become pregnant during the study 9. Use of concomitant prohibited medication other than ibuprofen 10. Obesity: body mass index (BMI) more than 30 kg/m^2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain, assessed by VAS 2. LFI 3. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)-pain, WOMAC-stiffness and WOMAC-physical ability Measured at baseline, 5, 15 and 30 days of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tumor necrosis factor alpha (TNFa) 2. C-reactive protein (CRP) 3. Matrix metelloproteinase-3 (MMP-3) Measured at baseline, 5, 15 and 30 days of the study. | — |
Countries
India
Outcome results
None listed