Celebrex Short Versus Long Therapy In Ostheoarthritis Of The Knee
Information source: Pfizer
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: Celebrex (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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 outcome: 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
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 and Contacts
Pfizer Investigational Site, Siena 53100, Italy
Pfizer Investigational Site, Palermo 90146, Italy
Pfizer Investigational Site, Genova 16132, Italy
Pfizer Investigational Site, Potenza 85100, Italy
Pfizer Investigational Site, Arenzano (GE) 16011, Italy
Pfizer Investigational Site, Genova 16100, Italy
Pfizer Investigational Site, Venezia 30122, Italy
Pfizer Investigational Site, Milano 20157, Italy
Pfizer Investigational Site, Roma 00149, Italy
Pfizer Investigational Site, Cagliari - Monserrato, Italy
Pfizer Investigational Site, Foggia 71100, Italy
Pfizer Investigational Site, Milano 20122, Italy
Pfizer Investigational Site, Jesi ( AN) 60035, Italy
Pfizer Investigational Site, Padova 35100, Italy
Pfizer Investigational Site, Pavia 27100, Italy
Pfizer Investigational Site, Rutigliano, BA 70018, Italy
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2002
Ending date: March 2006
Last updated: October 16, 2006
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