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

Condition(s) targeted: Osteoarthritis, Knee

Intervention: PF-04191834 (Drug); PF-04191834 placebo (Drug); Naproxen placebo (Drug); PF-04191834 placebo (Drug); PF-04191834 (Drug); Naproxen placebo (Drug); PF-04191834 (Drug); Naproxen (Drug); PF-04191834 placebo (Drug); Naproxen (Drug); PF-04191834 placebo (Drug); PF-04191834 (Drug)

Phase: Phase 2

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

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.

Official title: A Phase 2 Randomized, Double-Blinded, Double-Dummy, Placebo And Active Controlled Two Cohort Two-Way Cross-Over, Multi-Centre Clinical Trial To Examine The Pain Relief Produced By 2 Weeks Of Daily Oral Administration Of A 5-Lipoxygenase (5-Lox) Inhibitor PF-04191834 Alone And In Combination With Naproxen In Patients With Flare-Enriched Osteoarthritis Of The Knee

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

To evaluate the efficacy of PF-04191834 versus placebo in relieving pain as measured by the The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score in patients with osteoarthritis of the knee

To evaluate the efficacy of PF-04191834 plus naproxen versus naproxen in relieving pain as measured by the WOMAC Pain Score in patients with osteoarthritis of the knee

To evaluate the safety and tolerability of PF-04191834 in patients with osteoarthritis

To evaluate the safety and tolerability of PF-04191834 when co-administered with naproxen in patients with osteoarthritis

Secondary outcome:

To examine the pharmacokinetics of PF-04191834 in patients with osteoarthritis

To assess the levels of urinary LTE4 as a biomarker

WOMAC Stiffness Domain Score of PF-04191834 versus placebo and in combination with naproxen versus naproxen

WOMAC Physical Function Domain Score of PF-04191834 versus placebo and in combination with naproxen versus naproxen

WOMAC Total Score of PF-04191834 versus placebo and in combination with naproxen versus naproxen

Importance weighted Total WOMAC Score of PF-04191834 versus placebo and in combination with naproxen versus naproxen

Daily Pain Diary over active treatment periods of PF-04191834 versus placebo and in combination with naproxen versus naproxen

Subjects' use of rescue medication for subjects taking PF-04191834 versus placebo or PF-04191835 plus naproxen versus naproxen

Summary of plasma concentrations of PF-04191834

Summary of urinary LTE4 levels

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects must have a diagnosis of osteoarthritis based on the American College of

Rhematology criteria confirmed by an X-ray

- Subjects must be willing and able to stop all current pain therapy for the duration

of the study

- Subjects must be willing and able to complete a daily diary

Exclusion Criteria:

- BMI of >39 kg/m2

- Known allergy or hypersensitivity to naproxen

- Any condition or medical history that might interfere with the subject's ability to

complete the study visits and assessments

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

Pfizer Investigational Site, Quebec G1V 3M7, Canada; Not yet recruiting

Pfizer Investigational Site, Quebec G1W 4R4, Canada; Not yet recruiting

Pfizer Investigational Site, Peoria, Arizona 85381, United States; Recruiting

Pfizer Investigational Site, Phoenix, Arizona 85013, United States; Recruiting

Pfizer Investigational Site, Carmichael, California 95608, United States; Not yet recruiting

Pfizer Investigational Site, Fair Oaks, California 95628, United States; Not yet recruiting

Pfizer Investigational Site, Denver, Colorado 80209, United States; Recruiting

Pfizer Investigational Site, South Miami, Florida 33143, United States; Recruiting

Pfizer Investigational Site, Overland Park, Kansas 66211, United States; Recruiting

Pfizer Investigational Site, Overland Park, Kansas 66212, United States; Recruiting

Pfizer Investigational Site, St. Paul, Minnesota 55102, United States; Recruiting

Pfizer Investigational Site, St. Paul, Minnesota 55114, United States; Recruiting

Pfizer Investigational Site, Las Vegas, Nevada 89144, United States; Not yet recruiting

Pfizer Investigational Site, St. John's, Newfoundland and Labrador A1A 3R5, Canada; Recruiting

Pfizer Investigational Site, Fargo, North Dakota 58103, United States; Recruiting

Pfizer Investigational Site, Columbus, Ohio 43213, United States; Not yet recruiting

Pfizer Investigational Site, Philadelphia, Pennsylvania 19139, United States; Not yet recruiting

Pfizer Investigational Site, Sherbrooke, Quebec J1H 1Z1, Canada; Recruiting

Pfizer Investigational Site, Austin, Texas 78705, United States; Not yet recruiting

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

Starting date: July 2010
Last updated: September 14, 2010