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
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
Study Sites (1)
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