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Measuring Gait And Self-Reported Pain In Patients With Osteoarthritis Of The Knee Using Placebo/Oxycodone/Celecoxib.

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00484718
First received: June 8, 2007
Last updated: January 26, 2012
Last verified: January 2012

June 8, 2007
January 26, 2012
February 2008
June 2009   (final data collection date for primary outcome measure)
  • Gait assessments [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Knee Pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00484718 on ClinicalTrials.gov Archive Site
Patients global assessment of arthritic condition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Measuring Gait And Self-Reported Pain In Patients With Osteoarthritis Of The Knee Using Placebo/Oxycodone/Celecoxib.
Measures Of Gait And Self-Reported Pain In Patients With Osteoarthritis Of The Knee: A Randomized, Single-Blind Washout, Double-Blind Treatment, Double Dummy Cross-Over Pilot Trial Using Placebo, Oxycodone And Celecoxib (A9011030)

The Purpose of this trial is to evaluate the use of a cross-over trial design in an osteoarthritis population. We will determine the inter- and intra-subject variability in osteoarthritis (OA) endpoints and evaluate if efficacy can be detected by measuring OA endpoints following treatment with 2 different types of analgesics in a crossover study of this design.

Methodology study to evaluate the use of a cross over design and gait analysis. The study was terminated by mutual consent with the study site at a meeting on the 1 April 2009, because of slow recruitment due to a high screen fail rate. The study was not stopped for safety reasons.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Osteoarthritis
  • Drug: celecoxib
    oral, 100 mg bid
  • Drug: Oxycodone
    oral, 20 mg bid
  • Drug: placebo
    oral bid
  • Active Comparator: A
    Intervention: Drug: celecoxib
  • Active Comparator: B
    Intervention: Drug: Oxycodone
  • Placebo Comparator: C
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject has been taking an NSAID at least 15 of the past 30 days for index knee pain
  • Grades 2 or 3 OA as defined by the Kellgren and Lawrence Grading System of the medial tibiofemoral joint (joint space narrowing in the medial compartment > lateral compartment as assessed by x-ray) using the Altman Atlas of OA7. This must be documented with a report from an x-ray of the study joint taken either at screening or within 1 year prior to screening
  • Subject meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee, defined by the following: Knee pain and at least 3 of the following: oAge >50 oMorning stiffness <30 minutes oCrepitus on active motion oBony tenderness oBony enlargement oNo palpable warmth of synovium.

Exclusion Criteria:

  • Subject has a documented history of an allergic reaction (hives, rash, etc.) or a clinically significant intolerance to celecoxib, sulfonamides, aspirin, or opioids including oxycodone
  • Significant pain outside the index knee, including significant hip or back pain that can not be distinguished from OA pain or that interferes with ability to walk. (Patients with bilateral knee OA will be allowed into the study. The index knee should be defined as the more painful knee
  • Predominantly patellofemoral knee osteoarthritis in the index knee as assessed by clinical examination
  • Subject who are unable to discontinue all formulations of prior analgesics other than acetaminophen during the Washout Period of the study, or who are anticipated to be unable to discontinue rescue medication for 24 hours prior to the respective visits. (Low dose aspirin may be taken for cardiac prophylaxis
  • Excessive signal knee joint laxity indicative of functional ligamentous deficiency
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00484718
A9011030
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

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