Celebrex Short Versus Long Therapy In Osteoarthritis Of The Knee

June 9, 2008 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • 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, 20122
        • Pfizer Investigational Site
      • Milano, Italy, 20157
        • 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
        • Pfizer Investigational Site
    • BA
      • Rutigliano, BA, Italy, 70018
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

August 26, 2005

First Submitted That Met QC Criteria

August 26, 2005

First Posted (Estimate)

August 29, 2005

Study Record Updates

Last Update Posted (Estimate)

June 10, 2008

Last Update Submitted That Met QC Criteria

June 9, 2008

Last Verified

July 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 635-IFL-0508-015
  • A3191091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis,Knee

Clinical Trials on Celebrex

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe