Safety and Efficacy of Lumiracoxib Versus Naproxen in Acute Musculoskeletal Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

419 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Musculoskeletal Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Musculoskeletal pain cyclooxygenase-2 inhibitors lumiracoxib naproxen

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lumiracoxib

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals UK Limited Novartis Pharmaceuticals UK Limited

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals UK Limited

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

For site information contact, Novartis Pharmaceuticals UK Limited

Frimley, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1111/j.1742-1241.2008.01906.x.

Reference Type DERIVED

PMID: 19143855 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CCOX189AGB02

Identifier Type: -

Identifier Source: org_study_id