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):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: celecoxib Drug: Oxycodone Drug: placebo Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: 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)
Study Start Date : February 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: A Drug: celecoxib
oral, 100 mg bid

Active Comparator: B Drug: Oxycodone
oral, 20 mg bid

Placebo Comparator: C Drug: placebo
oral bid

Primary Outcome Measures :
  1. Gait assessments [ Time Frame: 12 weeks ]
  2. Knee Pain [ Time Frame: 12 weeks ]
  3. Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Patients global assessment of arthritic condition [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00484718

United States, California
Pfizer Investigational Site
Palo Alto, California, United States, 94304-1290
Pfizer Investigational Site
Stanford, California, United States, 94305
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pfizer Identifier: NCT00484718     History of Changes
Other Study ID Numbers: A9011030
First Posted: June 11, 2007    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Analgesics, Opioid
Central Nervous System Depressants