Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01102660

Collaborator

(none)

172

Enrollment

Locations

Arms

Duration (Months)

6.6

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

PH-797804 is a potent inhibitor of inflammatory mediators that have a potential role in pain signalling following nerve injury and inflammation. Blocking such mediators may potentially have a therapeutic benefit by reducing pain.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: PH-797804 Drug: Placebo Drug: Placebo Drug: PH-797804 Drug: Naproxen Drug: Naproxen + PH-797804 Drug: Naproxen + PH-797804 Drug: Naproxen	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

172 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Double-Dummy, Placebo And Active Controlled Two Period Four Treatment Cross-Over Clinical Trial To Examine The Pain Relief Of PH-797804 Alone Or With Naproxen In Subjects With Flare-Enriched Osteoarthritis Of The Knee

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Treatment Sequence 1	Drug: PH-797804 Tablet, 6 mg once daily for 2 weeks Drug: Placebo Tablet, 0 mg once daily for 2 weeks
Other: Treatment Sequence 2	Drug: Placebo Tablet, 0 mg once daily for 2 weeks Drug: PH-797804 Tablet, 6 mg once daily for 2 weeks
Other: Treatment Sequence 3	Drug: Naproxen Tablet, 500 mg twice daily for 2 weeks Drug: Naproxen + PH-797804 Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks
Other: Treatment Sequence 4	Drug: Naproxen + PH-797804 Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks Drug: Naproxen Tablet, 500 mg twice daily for 2 weeks

Outcome Measures

Primary Outcome Measures

Western Ontario & McMaster Osteoarthritis Index Pain Score [2 weeks]

Secondary Outcome Measures

Western Ontario & McMaster Osteoarthritis Index Stiffness Score [2 weeks]
Western Ontario & McMaster Osteoarthritis Index Physical Function Score [2 weeks]
Western Ontario & McMaster Osteoarthritis Index Total Score [2 weeks]
Daily Pain Rating Scale [2 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female subjects between, and including, the ages of 18 and 75 years. Females must be of non-childbearing potential.
Diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria with X-ray confirmation (a Kellgren-Lawrence X-ray grade of ≥2.

Exclusion Criteria:

History of diseases other than osteoarthritis that may involve the index knee.
Other severe pain that impairs the assessment of osteoarthritis of pain.
Electrocardiogram abnormalities.
History of gastrointestinal disorders.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Paramount	California	United States	90723
2	Pfizer Investigational Site	Spring Valley	California	United States	91978
3	Pfizer Investigational Site	Valley Village	California	United States	91607
4	Pfizer Investigational Site	Daytona Beach	Florida	United States	32117
5	Pfizer Investigational Site	Ormond Beach	Florida	United States	32174
6	Pfizer Investigational Site	Plantation	Florida	United States	33317
7	Pfizer Investigational Site	Plantation	Florida	United States	33324
8	Pfizer Investigational Site	South Miami	Florida	United States	33143
9	Pfizer Investigational Site	Gurnee	Illinois	United States	60031
10	Pfizer Investigational Site	Overland Park	Kansas	United States	66211
11	Pfizer Investigational Site	Overland Park	Kansas	United States	66212
12	Pfizer Investigational Site	Overland Park	Kansas	United States	66215
13	Pfizer Investigational Site	Prairie Village	Kansas	United States	66206
14	Pfizer Investigational Site	Wichita	Kansas	United States	67206
15	Pfizer Investigational Site	Fall River	Massachusetts	United States	02721
16	Pfizer Investigational Site	Hyannis	Massachusetts	United States	02601
17	Pfizer Investigational Site	New Bedford	Massachusetts	United States	02740
18	Pfizer Investigational Site	St. Louis	Missouri	United States	63141
19	Pfizer Investigational Site	Rochester	New York	United States	14609
20	Pfizer Investigational Site	Wilmington	North Carolina	United States	28401
21	Pfizer Investigational Site	Kettering	Ohio	United States	45429
22	Pfizer Investigational Site	Pawtucket	Rhode Island	United States	02860
23	Pfizer Investigational Site	Mt. Pleasant	South Carolina	United States	29464
24	Pfizer Investigational Site	New Tazewell	Tennessee	United States	37825
25	Pfizer Investigational Site	Dallas	Texas	United States	75235
26	Pfizer Investigational Site	San Antonio	Texas	United States	78209