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

Condition(s) targeted: Osteoarthritis

Intervention: celecoxib (Drug); Oxycodone (Drug); placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

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 design: Other, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study

Primary outcome:

Gait assessments

Knee Pain

WOMAC

Secondary outcome: Patients global assessment of arthritic condition

Detailed description: Methodology study to evaluate the use of a cross over design and gait analysis.

Minimum age: 40 Years. Maximum age: 75 Years. Gender(s): Both.

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

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Palo Alto, California 94304-1290, United States; Recruiting

Pfizer Investigational Site, Stanford, California 94305, United States; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: February 2008
Ending date: June 2009
Last updated: February 4, 2009