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

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00484718

Purpose

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
Osteoarthritis	Drug: celecoxib Drug: Oxycodone Drug: placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Oxycodone Celecoxib Oxycodone hydrochloride

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Patients global assessment of arthritic condition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484718

Locations

United States, California
Pfizer Investigational Site
Palo Alto, California, United States, 94304-1290
Pfizer Investigational Site
Stanford, California, United States, 94305

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00484718 History of Changes
Other Study ID Numbers:	A9011030
Study First Received:	June 8, 2007
Last Updated:	January 26, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Oxycodone
Celecoxib
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012