NCT00170898

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
419

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

October 13, 2006

Status Verified

June 1, 2006

First QC Date

September 9, 2005

Last Update Submit

October 12, 2006

Conditions

Musculoskeletal Pain

Keywords

Musculoskeletal paincyclooxygenase-2 inhibitorslumiracoxibnaproxen

Outcome Measures

Primary Outcomes (1)

  • Decrease in sum of pain intensity difference scores over first 5 days of treatment

Secondary Outcomes (2)

  • 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.

Interventions

LumiracoxibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

For site information contact, Novartis Pharmaceuticals UK Limited

Frimley, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 19143855DERIVED

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

lumiracoxib

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis Pharmaceuticals UK Limited Novartis Pharmaceuticals UK Limited

    Novartis Pharmaceuticals UK Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

November 1, 2004

Last Updated

October 13, 2006

Record last verified: 2006-06

Locations

GB(1)