Celebrex Short Versus Long Therapy In Osteoarthritis Of The Knee
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
2 other identifiers
interventional
200
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2002
Typical duration for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 26, 2005
CompletedFirst Posted
Study publicly available on registry
August 29, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedJune 10, 2008
July 1, 2006
3.3 years
August 26, 2005
June 9, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of OA of the knee according to the ACR Classification Criteria for osteoarthritis;
- patients in flare
You may not qualify if:
- any concomitant inflammatory rheumatic condition which may interfere with the assessment of OA
- clinical or radiological evidence of chondrocalcinosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (16)
Pfizer Investigational Site
Rutigliano, BA, 70018, Italy
Pfizer Investigational Site
Arenzano (GE), 16011, Italy
Pfizer Investigational Site
Cagliari - Monserrato, Italy
Pfizer Investigational Site
Foggia, 71100, Italy
Pfizer Investigational Site
Genova, 16100, Italy
Pfizer Investigational Site
Genova, 16132, Italy
Pfizer Investigational Site
Jesi ( AN), 60035, Italy
Pfizer Investigational Site
Milan, 20122, Italy
Pfizer Investigational Site
Milan, 20157, Italy
Pfizer Investigational Site
Padua, 35100, Italy
Pfizer Investigational Site
Palermo, 90146, Italy
Pfizer Investigational Site
Pavia, 27100, Italy
Pfizer Investigational Site
Potenza, 85100, Italy
Pfizer Investigational Site
Roma, 00149, Italy
Pfizer Investigational Site
Siena, 53100, Italy
Pfizer Investigational Site
Venezia, 30122, Italy
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 26, 2005
First Posted
August 29, 2005
Study Start
November 1, 2002
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
June 10, 2008
Record last verified: 2006-07