Health Condition 1: M199- Osteoarthritis, unspecified site
Conditions
Interventions
Intervention1: Aceclofenac 100 mg plus Paracetamol 500 mg tablets: One tablet of FDC of Aceclofenac 100 mg plus Paracetamol 500 mg tablets twice daily, one tablet in the morning and one in the evening
Sponsors
Ajanta Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects 18 to 65 years of age (Both Inclusive). 2. Subjects with acute painful musculoskeletal/musculospastic conditions like pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, minor pain of arthritis, muscular aches and backache. 3. Subjects who have pain score of at least 4 on a Numerical Rating Scale (11- point scale). 4. Subjects who are willing to give informed consent for participation in the study and willing to adhere to all protocol procedures.
Exclusion criteria
Exclusion criteria: 1. Subject has known allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication. 2. Subjects who have used NSAIDS or any other analgesic in last 24 hours. 3. Subjects who have taken any corticosteroid, indomethacin, glucosamine + chondroitin, within 3 months prior to the screening or intra-articular treatment injections with corticosteroid or hyaluronic acid within 6 months preceding the treatment period. 4. Subjects with clinically significant uncontrolled cardiovascular disease. 5. Subjects with history of peptic ulceration or active gastrointestinal (GI) bleeding or inflammatory bowel diseases. 6. Subjects with a history/existing case of bronchial asthma. 7. Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases or malignancies. 8. Subjects with abnormal Liver Function Test (LFT) values more than 3 times the upper limit of normal. 9. Subjects with renal dysfunction with serum creatinine value = 1.5 mg/dl at screening. 10. Subjects with known alcohol or other substance abuse within last one year as per DSM-5 criteria. 11. Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit. 12. Pregnant and lactating women or the women of child bearing age who are not ready to use effective means of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of pain as measured by Numerical Rating Scale (NRS) from Baseline to end of study that is 7th day of treatment.Timepoint: Reduction of pain as measured by Numerical Rating Scale (NRS) from Baseline to end of study that is 7th day of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in the Subjects Global Assessment. Change from Baseline in the Physician’s Global Assessment. Timepoint: Baseline to end of study | — |
Countries
India
Contacts
Public ContactDr Neeta Nargundkar
Biosphere Clinical Research Pvt Ltd
Outcome results
None listed