A 2 Week Blinded Study For Pain Due To Arthritis Of The Knee

Phase 2TerminatedNCT00483977

Pfizer113 enrolled

Overview

The primary aim is to assess if PF-00592379 is able to reduce pain in patients with osteoarthritis of the knee.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

113

Conditions

Osteoarthritis

Interventions

OxycodoneDRUG

Oxycodone: oral controlled release, 20 mg, twice a day for 2 weeks

PlaceboDRUG

Placebo: oral for 2 weeks.

PF-000592379DRUG

PF-00592379: oral, 30 mg, once a day for 2 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female of any race * Between the ages of 18 and 75 years * Knee Pain due to osteoarthritis Exclusion Criteria: * Pregnant * Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to baseline * History of malignancy, convulsions, chronic infections, arthroscopy of the worst knee within the past year

Locations (21)

Pfizer Investigational Site

Mobile, Alabama, United States

Outcomes

Primary Outcomes

Change from baseline in the pain score averaged over the last week of treatment

Time frame: 2 weeks

Secondary Outcomes

Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score - change from baseline to end of treatment

Time frame: 2 weeks

Patient Global Impression of Change

Time frame: 2 weeks

Patients Global Assessment of Osteoarthritis

Time frame: 2 weeks

Pharmacokinetic trough levels

Time frame: 2 weeks

Data from ClinicalTrials.gov

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