Back to resultsCelebrex Short Versus Long Therapy In Osteoarthritis Of The Knee
Primary Purpose
Osteoarthritis,Knee
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Celebrex
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis,Knee
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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00137410
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis,Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Celebrex
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Rutigliano
State/Province
BA
ZIP/Postal Code
70018
Country
Italy
Facility Name
Pfizer Investigational Site
City
Arenzano (GE)
ZIP/Postal Code
16011
Country
Italy
Facility Name
Pfizer Investigational Site
City
Cagliari - Monserrato
Country
Italy
Facility Name
Pfizer Investigational Site
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Genova
ZIP/Postal Code
16100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Pfizer Investigational Site
City
Jesi ( AN)
ZIP/Postal Code
60035
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Pfizer Investigational Site
City
Padova
ZIP/Postal Code
35100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Potenza
ZIP/Postal Code
85100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00149
Country
Italy
Facility Name
Pfizer Investigational Site
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Venezia
ZIP/Postal Code
30122
Country
Italy
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=635-IFL-0508-015&StudyName=Celebrex+Short+Versus+Long+Therapy+In+Ostheoarthritis+Of+The+Knee
Description
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Learn more about this trial
Celebrex Short Versus Long Therapy In Osteoarthritis Of The Knee
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