Safety and Efficacy of Lumiracoxib Versus Naproxen in Acute Musculoskeletal Pain

Musculoskeletal Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170898
• Other study ID #: CCOX189AGB02
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: October 12, 2006
• Start date: November 2004

Study information

• Verified date: June 2006
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Musculoskeletal Pain

Intervention

Drug:
• Lumiracoxib

Locations

Country	Name	City	State
United Kingdom	For site information contact, Novartis Pharmaceuticals UK Limited	Frimley

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in sum of pain intensity difference scores over first 5 days of treatment
Secondary	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
Secondary	Safety and efficacy as compared to naproxen.