Status:
COMPLETED
Safety and Efficacy of Lumiracoxib Versus Naproxen in Acute Musculoskeletal Pain
Lead Sponsor:
Novartis
Conditions:
Musculoskeletal Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is designed to develop our understanding of the risk-benefit of using lumiracoxib in patients with acute musculoskeletal pain due to uncomplicated soft tissue injury.
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients with acute musculoskeletal pain following an uncomplicated soft tissue injury (within the last 72 hours) which is expected to be self-limiting, requiring short-term treatment with a NSAID.
- Patients' acute musculoskeletal pain at baseline must be ≥ 50 mm on a 0 - 100 mm on a Visual Analogue Scale.
- Patients may have taken analgesic therapy following injury. However, the baseline pain intensity assessment should be taken: (i) 4 hours after the last dose of ≤ 400 mg ibuprofen, ≤ 1000 mg paracetamol, ≤ 600 mg aspirin or ≤ 2 tablets of other over-the-counter analgesic aspirin-based or paracetamol-based combination medications (ii) or 8 hours after the last dose of \> 400 mg ibuprofen or ≤ 50 mg diclofenac
- Exclusion Criteria
- Patients whose pain is due to an acute exacerbation of a chronic condition e.g. osteoarthritis, rheumatoid arthritis, systemic lupus erythematosus.
- Patients who have taken non-steroidal anti-inflammatory drugs in the previous 24 hours (other than aspirin, ibuprofen, diclofenac, as described above).
- Other protocol-defined inclusion/ exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
419 Patients enrolled
Trial Details
Trial ID
NCT00170898
Start Date
November 1 2004
Last Update
October 13 2006
Active Locations (1)
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1
For site information contact, Novartis Pharmaceuticals UK Limited
Frimley, United Kingdom