Efficacy and Safety of Lumiracoxib 400 mg in Arthroscopic Knee Surgery

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00333567

Enrollment

110

Registered

2006-06-05

Start date

2006-08-31

Completion date

Unknown

Last updated

2007-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

arthroscopic knee surgery, cyclooxygenase-2 inhibitors, lumiracoxib, COX189, Ambulatory arthroscopic knee surgery

Brief 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

Interventions

DRUGLumiracoxib

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Pain Intensity (PI) in the target knee after movement at the 2 h time-point	—

Secondary

Measure	Time frame
PI at 1, 2, 3, 4 and 24 h time-points while at rest	—
PI at 1, 3, 4 and 24 h time-points after movement	—
Time to first rescue medication intake	—
Patient's global evaluation of response to study medication	—
Safety and tolerability profile	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026