Safety and Efficacy of Lumiracoxib Versus Naproxen in Acute Musculoskeletal Pain

This study has been completed.

First Received on September 9, 2005. Last Updated on October 12, 2006 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00170898

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 IV

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:

Drug Information available for: Naproxen Naproxen sodium Lumiracoxib

U.S. FDA Resources

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):

Kyle C, Zachariah J, Kinch H, Ellis G, Andrews C, Adekunle F. A randomised, double-blind study comparing lumiracoxib with naproxen for acute musculoskeletal pain. Int J Clin Pract. 2008 Nov;62(11):1684-92.

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 February 09, 2012