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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00484718
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : June 11, 2007
Last Update Posted : January 31, 2012
Information provided by (Responsible Party):

June 8, 2007
June 11, 2007
January 31, 2012
February 2008
June 2009   (Final data collection date for primary outcome measure)
  • Gait assessments [ Time Frame: 12 weeks ]
  • Knee Pain [ Time Frame: 12 weeks ]
  • Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) [ Time Frame: 12 weeks ]
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Complete list of historical versions of study NCT00484718 on Archive Site
Patients global assessment of arthritic condition [ Time Frame: 12 weeks ]
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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.
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
  • 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 Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
40 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Study Director: Pfizer Call Center Pfizer
January 2012

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