Clinical trial NCT00484718: Measuring Gait And Self-Reported Pain In Patients With Osteoarthritis Of The Knee Using Placebo/Oxycodone/Celecoxib.
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-11
Enrollment: 6
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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 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

Primary outcomes:
measure: Change From Baseline in Knee Pain Intensity Measured by Numeric Rating Scale (NRS) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Knee Pain Intensity Measured by Visual Analog Scale (VAS) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Pain Subscale Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Physical Function Subscale Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Stiffness Subscale Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Total Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Knee Adduction Moment at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Quadriceps Inhibition at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Peak Ground Reaction Force at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Total Ground Reaction Force at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Stride Length at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Walking Speed at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Cadence at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Patient Global Assessment of Arthritic Condition (PGAAC) Score at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VAPAHCS
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Asay JL, Boyer KA, Andriacchi TP. Repeatability of gait analysis for measuring knee osteoarthritis pain in patients with severe chronic pain. J Orthop Res. 2013 Jul;31(7):1007-12. doi: 10.1002/jor.22228. Epub 2013 Mar 18.
citation: Boyer KA, Angst MS, Asay J, Giori NJ, Andriacchi TP. Sensitivity of gait parameters to the effects of anti-inflammatory and opioid treatments in knee osteoarthritis patients. J Orthop Res. 2012 Jul;30(7):1118-24. doi: 10.1002/jor.22037. Epub 2011 Dec 16.