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OpenTrials
Completed

NCT Number: NCT00333567

Efficacy and Safety of Lumiracoxib 400 mg in Arthroscopic Knee Surgery

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis

Nuremberg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lumiracoxib

Drug

Primary outcomes

  1. Pain Intensity (PI) in the target knee after movement at the 2 h time-point

Secondary outcomes

  1. PI at 1, 2, 3, 4 and 24 h time-points while at rest

  2. PI at 1, 3, 4 and 24 h time-points after movement

  3. Time to first rescue medication intake

  4. Patient's global evaluation of response to study medication

  5. Safety and tolerability profile

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2006
First posted
Jun 5, 2006
Registry last updated
Dec 13, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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