Celebrex Short Versus Long Therapy In Osteoarthritis Of The Knee

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NCT00137410

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Study Location
Pfizer Investigational Site
Rutigliano, BA, 70018, Italy
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis,Knee
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- diagnosis of OA of the knee according to the ACR Classification Criteria for osteoarthritis;

- patients in flare

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- any concomitant inflammatory rheumatic condition which may interfere with the
assessment of OA


- clinical or radiological evidence of chondrocalcinosis

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Pfizer Clinical Trials Contact Center

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Osteoarthritis,KneeCelebrex Short Versus Long Therapy In Osteoarthritis Of The Knee
NCT00137410
  1. Rutigliano, BA
  2. Arenzano (GE),
  3. Cagliari - Monserrato,
  4. Foggia,
  5. Genova,
  6. Genova,
  7. Jesi ( AN),
  8. Milano,
  9. Milano,
  10. Padova,
  11. Palermo,
  12. Pavia,
  13. Potenza,
  14. Roma,
  15. Siena,
  16. Venezia,
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Celebrex Short Versus Long Therapy In Osteoarthritis Of The Knee
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis,Knee
Intervention  ICMJE Drug: Celebrex
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 26, 2005)		200
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2006
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00137410
Other Study ID Numbers  ICMJE 635-IFL-0508-015
A3191091
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Directorm Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP