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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: PH-797804
* Drug: Placebo
* Drug: Placebo
* Drug: PH-797804
* Drug: Naproxen
* Drug: Naproxen + PH-797804
* Drug: Naproxen + PH-797804
* Drug: Naproxen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario & McMaster Osteoarthritis Index Pain Score |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee osteoarthritis, clinical trial, cross-over