Efficacy and Safety of Lumiracoxib 400 mg in Arthroscopic Knee Surgery

Pain Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Compare Efficacy of a Single Dose of Lumiracoxib 400 mg Given Pre-Emptively Versus Post-Operatively, in Reducing Pain Associated With Ambulatory Arthroscopic Knee Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333567
• Other study ID #: CCOX189A2427
• Status: Completed
• Phase: Phase 4
• First received: June 1, 2006
• Last updated: December 12, 2007
• Start date: August 2006

Study information

• Verified date: December 2007
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This study is designed to investigate the efficacy and safety of a single daily dose of 400 mg lumiracoxib given pre-emptively versus post-operatively in terms of efficacy in reducing pain associated with ambulatory arthroscopic knee surgery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who need scheduled minor ambulatory arthroscopic knee surgery.

Exclusion Criteria:

• Patients with any surgical or medical conditions which could place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Lumiracoxib

Locations

Country	Name	City	State
Germany	Novartis	Nuernberg

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity (PI) in the target knee after movement at the 2 h time-point
Secondary	PI at 1, 2, 3, 4 and 24 h time-points while at rest
Secondary	PI at 1, 3, 4 and 24 h time-points after movement
Secondary	Time to first rescue medication intake
Secondary	Patient's global evaluation of response to study medication
Secondary	Safety and tolerability profile