Celebrex Short Versus Long Therapy In Osteoarthritis Of The Knee
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00137410
First received: August 26, 2005
Last updated: June 9, 2008
Last verified: July 2006
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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:
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 | |
| 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 Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 23, 2013