Safety and Efficacy of Lumiracoxib Versus Naproxen in Acute Musculoskeletal Pain

Condition(s) targeted: Musculoskeletal Pain

Intervention: Lumiracoxib (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals UK Limited Novartis Pharmaceuticals UK Limited, Study Director, Affiliation: Novartis Pharmaceuticals UK Limited

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.

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Decrease in sum of pain intensity difference scores over first 5 days of treatment

Secondary outcome:

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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.

For site information contact, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom

Starting date: November 2004
Last updated: October 12, 2006