Clinical trial NCT01147458: A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Keywords: Cross-over
safety
efficacy
tolerability
osteoarthritis
knee
pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study has been terminated in response to a reported serious adverse event (SAE). The sponsor's assessment of the limited data available at the time of the initial SAE report was that the SAE may alter the potential benefit - risk profile of the study medication.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 1
timeFrame: Baseline (Day 1 of Visit 3) and end of treatment Period 1 (Day 15+1 of Visit 5)
measure: Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 2
timeFrame: Baseline (Day 28 of Visit 7) and end of treatment Period 2 (Day 43+1 of Visit 9)
Secondary outcomes:
measure: WOMAC Stiffness Domain Score
timeFrame: Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2
measure: WOMAC Physical Function Domain Score
timeFrame: Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2
measure: WOMAC Total Score
timeFrame: Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2
measure: Importance Weighted Total WOMAC Score
timeFrame: Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2
measure: Daily Diary Pain Score During Week 1 of Each Treatment Period
timeFrame: 4 days prior to baseline visits (Visits 3 for Period 1 and Vist 8 for Period 2) up to 7 days after baseline visits
measure: Daily Diary Pain Score During Week 2 of Each Treatment Period
timeFrame: Over the last 4 days before baseline visits (Visits 3 for Period 1 and Visit 8 for Period 2) and over the last 6 days before Visit 5 for Period 1 and Visit 9 for Period 2
measure: Rescue Medication Use
timeFrame: Day -7 (Visit 2) up to 28-day follow-up (Visit 10)
measure: Plasma Concentration of PF-04191834
timeFrame: Pre-dose and post-dose (1 to 3 hours) on Days 1, 8, 15, 29, 36, and 43
measure: Urinary Leukotriene E4 (LTE4) Levels
timeFrame: Day -7 (Visit 2) up to Day 43 (Visit 9 or End of Treatment Period 2)
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Carmichael
country: United States
facility: Pfizer Investigational Site
state: California
city: Fair Oaks
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: DeLand
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pensacola
country: United States
facility: Pfizer Investigational Site
state: Florida
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: South Bend
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Edina
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: St. Paul
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Monroe
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: St. John's
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: