Celebrex Short Versus Long Therapy In Osteoarthritis Of The Knee

Pfizer200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Osteoarthritis,Knee

Interventions

CelebrexDRUG

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (16)

Pfizer Investigational Site

Rutigliano, BA, Italy

Pfizer Investigational Site

Arenzano (GE), Italy

Pfizer Investigational Site

Cagliari - Monserrato, Italy

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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