Celebrex Short Versus Long Therapy In Osteoarthritis Of The Knee

Osteoarthritis,Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137410
• Other study ID #: 635-IFL-0508-015
• Secondary ID: A3191091
• Status: Completed
• Phase: Phase 3
• First received: August 26, 2005
• Last updated: June 9, 2008
• Start date: November 2002
• Est. completion date: March 2006

Study information

• Verified date: July 2006
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Osteoarthritis,Knee

Intervention

Drug:
• Celebrex

Locations

Country	Name	City	State
Italy	Pfizer Investigational Site	Arenzano (GE)
Italy	Pfizer Investigational Site	Cagliari - Monserrato
Italy	Pfizer Investigational Site	Foggia
Italy	Pfizer Investigational Site	Genova
Italy	Pfizer Investigational Site	Genova
Italy	Pfizer Investigational Site	Jesi ( AN)
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Padova
Italy	Pfizer Investigational Site	Palermo
Italy	Pfizer Investigational Site	Pavia
Italy	Pfizer Investigational Site	Potenza
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Rutigliano	BA
Italy	Pfizer Investigational Site	Siena
Italy	Pfizer Investigational Site	Venezia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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