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Clinical Trials/NCT01102660
NCT01102660CompletedPhase 2

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

Pfizer1 site in 1 country172 target enrollmentStarted: May 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Pfizer
Enrollment
172
Locations
1
Primary Endpoint
Western Ontario & McMaster Osteoarthritis Index Pain Score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Treatment Sequence 3

Other

Intervention: Naproxen (Drug)

Treatment Sequence 1

Other

Intervention: PH-797804 (Drug)

Treatment Sequence 1

Other

Intervention: Placebo (Drug)

Treatment Sequence 2

Other

Intervention: Placebo (Drug)

Treatment Sequence 2

Other

Intervention: PH-797804 (Drug)

Treatment Sequence 3

Other

Intervention: Naproxen + PH-797804 (Drug)

Treatment Sequence 4

Other

Intervention: Naproxen + PH-797804 (Drug)

Treatment Sequence 4

Other

Intervention: Naproxen (Drug)

Outcomes

Primary Outcomes

Western Ontario & McMaster Osteoarthritis Index Pain Score

Time Frame: 2 weeks

Secondary Outcomes

  • 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)

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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