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

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis, Knee	Drug: PF-04191834 Drug: PF-04191834 placebo Drug: Naproxen placebo Drug: Naproxen	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of PF-04191834 in patients with osteoarthritis [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
To evaluate the safety and tolerability of PF-04191834 when co-administered with naproxen in patients with osteoarthritis [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To examine the pharmacokinetics of PF-04191834 in patients with osteoarthritis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
To assess the levels of urinary LTE4 as a biomarker [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
WOMAC Stiffness Domain Score of PF-04191834 versus placebo and in combination with naproxen versus naproxen [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
WOMAC Physical Function Domain Score of PF-04191834 versus placebo and in combination with naproxen versus naproxen [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
WOMAC Total Score of PF-04191834 versus placebo and in combination with naproxen versus naproxen [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Importance weighted Total WOMAC Score of PF-04191834 versus placebo and in combination with naproxen versus naproxen [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Daily Pain Diary over active treatment periods of PF-04191834 versus placebo and in combination with naproxen versus naproxen [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Subjects' use of rescue medication for subjects taking PF-04191834 versus placebo or PF-04191835 plus naproxen versus naproxen [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Summary of plasma concentrations of PF-04191834 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Summary of urinary LTE4 levels [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	190
Study Start Date:	July 2010
Study Completion Date:	February 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PF-04191834 followed by placebo PF-04191834 600 mg BID dose followed by matched placebo plus naproxen placebo.	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
Experimental: Placebo followed by PF-04191834 Placebo followed by 600 mg BID dose of PF-04191834 plus naproxen placebo.	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
Experimental: PF-04191834+Naproxen followed by Naproxen PF-04191834 600 mg BID + Naproxen 500 mg BID followed by Naproxen 500 mg BID plus PF-04191834 placebo	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
Experimental: Naproxen followed by PF-04191834+Naproxen Naproxen 500 mg BID followed by PF-04191834 600 mg BID + Naproxen 500 mg BID	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

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147458

Show 31 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT01147458 History of Changes
Other Study ID Numbers:	B0041007
Study First Received:	June 16, 2010
Last Updated:	May 31, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Cross-over
safety
efficacy
tolerability

osteoarthritis
knee
pain

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013