Celebrex Short Versus Long Therapy In Osteoarthritis Of The Knee

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00137410
First received: August 26, 2005
Last updated: June 9, 2008
Last verified: July 2006
  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 3

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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Italy
Pfizer Investigational Site
Rutigliano, BA, Italy, 70018
Pfizer Investigational Site
Arenzano (GE), Italy, 16011
Pfizer Investigational Site
Cagliari - Monserrato, Italy
Pfizer Investigational Site
Foggia, Italy, 71100
Pfizer Investigational Site
Genova, Italy, 16132
Pfizer Investigational Site
Genova, Italy, 16100
Pfizer Investigational Site
Jesi ( AN), Italy, 60035
Pfizer Investigational Site
Milano, Italy, 20157
Pfizer Investigational Site
Milano, Italy, 20122
Pfizer Investigational Site
Padova, Italy, 35100
Pfizer Investigational Site
Palermo, Italy, 90146
Pfizer Investigational Site
Pavia, Italy, 27100
Pfizer Investigational Site
Potenza, Italy, 85100
Pfizer Investigational Site
Roma, Italy, 00149
Pfizer Investigational Site
Siena, Italy, 53100
Pfizer Investigational Site
Venezia, Italy, 30122
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 19, 2014