Celebrex Short Versus Long Therapy In Osteoarthritis Of The Knee

Protocol For A Multicentre, Double Blind, Parallel Group Pilot Study To Compare Celecoxib Long Term Vs Celecoxib Short Term Therapy In Treatment And Prevention Of New Flare In Patients With Osteoarthritis Of The Knee

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00137410

Enrollment

200

Registered

2005-08-29

Start date

2002-11-30

Completion date

2006-03-31

Last updated

2008-06-10

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

Conditions

Osteoarthritis,Knee

Brief summary

This is a phase III, multicentre, randomized, double blind, parallel-group, pilot study designed to compare a long term (12 weeks) versus a short term (2 weeks) treatment with celecoxib 200 mg/die in treatment and prevention of new flare in patients with osteoarthritis of the knee.

Interventions

DRUGCelebrex

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* diagnosis of OA of the knee according to the ACR Classification Criteria for osteoarthritis; * patients in flare

Exclusion criteria

* any concomitant inflammatory rheumatic condition which may interfere with the assessment of OA * clinical or radiological evidence of chondrocalcinosis

Design outcomes

Primary

Measure	Time frame
Time elapsing between the last drug administration and a new flare, if any, occurring within a 12 months FU and proportion pts with a new flare	—

Secondary

Measure	Time frame
Flare intensity WOMAC OA index Psycho-affective Index Pt's assessment of OA pain (VAS) Pt's & Physician's global assessment disease severity Incidence of total AEs Incidence of GI AEs: Incidence of changes in: hematology, renal function, liver function	—

Countries

Italy

Outcome results

None listed

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