Efficacy and Safety of Lumiracoxib 400 mg in Arthroscopic Knee Surgery

Novartis110 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

110

Conditions

Pain

Interventions

LumiracoxibDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis

Nuremberg, Germany

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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