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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.)
Information provided by (Responsible Party):
Pfizer Identifier:
First received: June 8, 2007
Last updated: January 26, 2012
Last verified: January 2012
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 Intervention
Drug: celecoxib
Drug: Oxycodone
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (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)

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 6
Study Start Date: February 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
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
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Please refer to this study by its identifier: 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
  More Information

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
Study First Received: June 8, 2007
Last Updated: January 26, 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 processed this record on April 21, 2017