Celebrex Short Versus Long Therapy In Osteoarthritis Of The Knee
NCT00137410
Last updated date
ABOUT THIS STUDY
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.
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
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
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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Osteoarthritis,KneeCelebrex Short Versus Long Therapy In Osteoarthritis Of The Knee
NCT00137410
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- Jesi ( AN),
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- Milano,
- Padova,
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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 | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||