Celebrex Short Versus Long Therapy In Osteoarthritis Of The Knee
Overview[ - collapse ][ - ]
| 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 | Osteoarthritis,Knee |
| Intervention | Drug: Celebrex |
| Phase | Phase 3 |
| Sponsor | Pfizer |
| Responsible Party | Pfizer |
| ClinicalTrials.gov Identifier | NCT00137410 |
| First Received | August 26, 2005 |
| Last Updated | June 9, 2008 |
| Last verified | July 2006 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 26, 2005 |
|---|---|
| Last Updated Date | June 9, 2008 |
| Start Date | November 2002 |
| Estimated Primary Completion Date | March 2006 |
| Current 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 |
| Current 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 |
Descriptive Information[ + expand ][ + ]
| Brief Title | Celebrex Short Versus Long Therapy In Osteoarthritis Of The Knee |
|---|---|
| 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 |
| Brief 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition | Osteoarthritis,Knee |
| Intervention | Drug: Celebrex |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 200 |
| Estimated Completion Date | March 2006 |
| Estimated Primary Completion Date | March 2006 |
| Eligibility 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 |
| Gender | Both |
| Ages | 50 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Italy |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00137410 |
|---|---|
| Other Study ID Numbers | 635-IFL-0508-015 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Pfizer |
| Study Sponsor | Pfizer |
| Collaborators | Not Provided |
| Investigators | Study Director: Pfizer CT.gov Call Center Pfizer |
| Verification Date | July 2006 |
Locations[ + expand ][ + ]
| 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 |