Safety and Efficacy of Lumiracoxib Versus Naproxen in Acute Musculoskeletal Pain
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00170898
First received: September 9, 2005
Last updated: October 12, 2006
Last verified: June 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Musculoskeletal Pain |
Drug: Lumiracoxib |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A 7-Day Multicenter Randomized Double-Blind, Double-Dummy Parallel Group Trial to Assess the Safety and Efficacy of 400 mg Lumiracoxib Once Daily Versus 500 mg Naproxen Twice Daily in Patients With Acute Musculoskeletal Pain Due to Uncomplicated Soft Tissue Injury |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Decrease in sum of pain intensity difference scores over first 5 days of treatment
Secondary Outcome Measures:
- Decrease in sum of pain intensity difference scores over 7 days of treatment; Improvement in how pts feel about their pain; Comparable perceived pain relief; Comparable treatment satisfaction
- Safety and efficacy as compared to naproxen.
| Estimated Enrollment: | 419 |
| Study Start Date: | November 2004 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00170898
Locations
| United Kingdom | |
| For site information contact, Novartis Pharmaceuticals UK Limited | |
| Frimley, United Kingdom | |
Sponsors and Collaborators
Novartis
Investigators
| Study Director: | Novartis Pharmaceuticals UK Limited Novartis Pharmaceuticals UK Limited | Novartis Pharmaceuticals UK Limited |
More Information
No publications provided by Novartis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00170898 History of Changes |
| Other Study ID Numbers: | CCOX189AGB02 |
| Study First Received: | September 9, 2005 |
| Last Updated: | October 12, 2006 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Novartis:
|
Musculoskeletal pain cyclooxygenase-2 inhibitors lumiracoxib naproxen |
Additional relevant MeSH terms:
|
Naproxen Lumiracoxib Diclofenac Cyclooxygenase 2 Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013