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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-17

Study Completion Date

2009-06-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type ACTIVE_COMPARATOR

celecoxib

Intervention Type DRUG

oral, 100 mg bid

B

Group Type ACTIVE_COMPARATOR

Oxycodone

Intervention Type DRUG

oral, 20 mg bid

C

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral bid

Interventions

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celecoxib

oral, 100 mg bid

Intervention Type DRUG

Oxycodone

oral, 20 mg bid

Intervention Type DRUG

placebo

oral bid

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No