Safety and Efficacy of Lumiracoxib Versus Naproxen in Acute Musculoskeletal Pain

October 12, 2006 updated by: Novartis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

419

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Director: Novartis Pharmaceuticals UK Limited Novartis Pharmaceuticals UK Limited, Novartis Pharmaceuticals UK Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

October 13, 2006

Last Update Submitted That Met QC Criteria

October 12, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCOX189AGB02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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