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A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee

NCT01147458 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2013-06-06

Study results available
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Summary

PF-04191834 works in animal models by inhibiting one of the enzymes, 5-lipoxygenasein which is involved in the pathway that causes inflammation and pain. The purpose of this study is to test how effective, safe and tolerated PF-04191834 is in patients with osteoarthritis of the knee by itself or with naproxen, particularly to test if patients have less pain.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

PF-04191834

100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks

DRUG

PF-04191834 placebo

Matching PF-04191834 placebo tablets to be administered BID for two weeks

DRUG

Naproxen placebo

Matching naproxen placebo tablets to be administered BID for 4 weeks

DRUG

PF-04191834 placebo

Matching PF-04191834 placebo tablets to be administered BID for two weeks

DRUG

PF-04191834

100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks

DRUG

Naproxen placebo

Matching naproxen placebo tablets to be administered BID for 4 weeks

DRUG

PF-04191834

100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks

DRUG

Naproxen

Naproxen 500 mg tablet administered BID for a total of four weeks

DRUG

PF-04191834 placebo

Matching PF-04191834 placebo tablets to be administered BID for two weeks

DRUG

Naproxen

Naproxen 500 mg tablet administered BID for a total of four weeks

DRUG

PF-04191834 placebo

Matching PF-04191834 placebo tablets to be administered BID for two weeks

DRUG

PF-04191834

100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States
  • Canada
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01147458 on ClinicalTrials.gov