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

Phase 2

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Naproxen + PH-797804; Drug: PH-797804; Drug: Placebo; Drug: Naproxen

• Registration Number: NCT01102660
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Study Start: 2010-05
• Primary Completion: 2011-02
• Study Completion: 2011-03
• Disposition First Submitted: 2012-10-01
• Disposition First Submitted QC: 2012-10-01
• Disposition First Posted: 2012-10-05
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-20
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Sequence 1	Placebo	-
Treatment Sequence 4	Naproxen + PH-797804	-
Treatment Sequence 2	Placebo	-
Treatment Sequence 3	Naproxen + PH-797804	-
Treatment Sequence 4	Naproxen	-
Treatment Sequence 3	Naproxen	-
Treatment Sequence 1	PH-797804	-
Treatment Sequence 2	PH-797804	-

Primary Outcome Measures

Name	Time	Method
Western Ontario & McMaster Osteoarthritis Index Pain Score	2 weeks

Secondary Outcome Measures

Name	Time	Method
Western Ontario & McMaster Osteoarthritis Index Total Score	2 weeks
Daily Pain Rating Scale	2 weeks
Western Ontario & McMaster Osteoarthritis Index Stiffness Score	2 weeks
Western Ontario & McMaster Osteoarthritis Index Physical Function Score	2 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 San Antonio, Texas, United States