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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01102660
First received: April 12, 2010
Last updated: October 8, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Osteoarthritis
Drug: PH-797804
Drug: Placebo
Drug: Naproxen
Drug: Naproxen + PH-797804
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Western Ontario & McMaster Osteoarthritis Index Pain Score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Western Ontario & McMaster Osteoarthritis Index Stiffness Score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Western Ontario & McMaster Osteoarthritis Index Physical Function Score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Western Ontario & McMaster Osteoarthritis Index Total Score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Daily Pain Rating Scale [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 174
Study Start Date: May 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment Sequence 1 Drug: PH-797804
Tablet, 6 mg once daily for 2 weeks
Drug: Placebo
Tablet, 0 mg once daily for 2 weeks
Treatment Sequence 2 Drug: Placebo
Tablet, 0 mg once daily for 2 weeks
Drug: PH-797804
Tablet, 6 mg once daily for 2 weeks
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102660

  Show 26 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01102660     History of Changes
Other Study ID Numbers: A6631026
Study First Received: April 12, 2010
Last Updated: October 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Knee osteoarthritis
clinical trial
cross-over

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014