Celebrex Short Versus Long Therapy In Osteoarthritis Of The Knee - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00137410

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis,Knee	Drug: Celebrex	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 Measures:

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

Estimated Enrollment:	200
Study Start Date:	November 2002
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137410

Locations

Italy
Pfizer Investigational Site
Siena, Italy, 53100
Pfizer Investigational Site
Palermo, Italy, 90146
Pfizer Investigational Site
Genova, Italy, 16132
Pfizer Investigational Site
Potenza, Italy, 85100
Pfizer Investigational Site
Milano, Italy, 20157
Pfizer Investigational Site
Genova, Italy, 16100
Pfizer Investigational Site
Venezia, Italy, 30122
Pfizer Investigational Site
Arenzano (GE), Italy, 16011
Pfizer Investigational Site
Roma, Italy, 00149
Pfizer Investigational Site
Cagliari - Monserrato, Italy
Pfizer Investigational Site
Foggia, Italy, 71100
Pfizer Investigational Site
Milano, Italy, 20122
Pfizer Investigational Site
Jesi ( AN), Italy, 60035
Pfizer Investigational Site
Padova, Italy, 35100
Pfizer Investigational Site
Pavia, Italy, 27100
Italy, BA
Pfizer Investigational Site
Rutigliano, BA, Italy, 70018

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Directorm Clinical Trial Disclosure Group )
Study ID Numbers:	635-IFL-0508-015, A3191091
Study First Received:	August 26, 2005
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00137410 History of Changes
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Anti-Inflammatory Agents
Celecoxib
Osteoarthritis
Joint Diseases
Cyclooxygenase Inhibitors
Rheumatic Diseases
Osteoarthritis, Knee

Musculoskeletal Diseases
Analgesics, Non-Narcotic
Arthritis
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Celecoxib
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Joint Diseases
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Rheumatic Diseases
Pharmacologic Actions
Osteoarthritis, Knee

Musculoskeletal Diseases
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Arthritis
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009