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: August 20, 2014
Last verified: August 2014
  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: 172
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 20, 2014
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
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014