NCT00333567

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
Last Updated

December 13, 2007

Status Verified

December 1, 2007

First QC Date

June 1, 2006

Last Update Submit

December 12, 2007

Conditions

Pain

Keywords

arthroscopic knee surgerycyclooxygenase-2 inhibitorslumiracoxibCOX189Ambulatory arthroscopic knee surgery

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • 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

Interventions

LumiracoxibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who need scheduled minor ambulatory arthroscopic knee surgery.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Nuremberg, Germany

Location

MeSH Terms

Conditions

Pain

Interventions

lumiracoxib

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis Pharma AG

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 1, 2006

First Posted

June 5, 2006

Study Start

August 1, 2006

Last Updated

December 13, 2007

Record last verified: 2007-12

Locations

DE(1)