To compare the efficacy and safety of Diclofenac 25 mg + paracetamol 325 mg FDC vs. Aceclofenac 100mg in the management of osteoarthritis
- Conditions
- Health Condition 1: null- osteoarthritis.
- Registration Number
- CTRI/2010/091/000076
- Lead Sponsor
- Troikaa Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
1. Male or females patients aged 45-80 years.
2 Patients with a working diagnosis of osteoarthritis as defined by
NICE 2008 guidelines (Appendix-II)
3. At least moderate pain within past 2 weeks
1. Secondary osteoarthritis related to syphilis, metabolic bone disorder, acute trauma
2. Hypersensitivity to aspirin/ NSAID or any other component of the formulation
3. Any contra-indication to either medication.
4. Clinically active hepatic or peptic ulcer disease
5. H/O alcohol or drug abuse
6. Clinically significant impairment of hepatic and renal functions
7. Corticosteroid use
8. Use of any other analgesic or glucosamine
9. Baseline laboratory values outside the clinically acceptable limits
10. Pregnant women and lactating mothers
11. Women of child bearing age not practicing or not willing to use contraceptive
12. Patients or relatives unwilling to give written informed consent
13. Participation in a clinical study involving an investigational product within past 120 days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method