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

• ClinicalTrials.gov Identifier: NCT01102660
• Recruitment Status: Completed
• First Posted: April 13, 2010
• Last Update Posted: August 22, 2014
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: April 12, 2010
• First Posted Date: April 13, 2010
• Last Update Posted Date: August 22, 2014
• Study Start Date: May 2010
• Actual Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 12, 2010): Western Ontario & McMaster Osteoarthritis Index Pain Score [ Time Frame: 2 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 12, 2010)

• Western Ontario & McMaster Osteoarthritis Index Stiffness Score [ Time Frame: 2 weeks ]
• Western Ontario & McMaster Osteoarthritis Index Physical Function Score [ Time Frame: 2 weeks ]
• Western Ontario & McMaster Osteoarthritis Index Total Score [ Time Frame: 2 weeks ]
• Daily Pain Rating Scale [ Time Frame: 2 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee
• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Osteoarthritis

Intervention

• Drug: PH-797804
  Tablet, 6 mg once daily for 2 weeks
• Drug: Placebo
  Tablet, 0 mg once daily for 2 weeks
• 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

Study Arms

• Treatment Sequence 1
  Interventions:

  • Drug: PH-797804
  • Drug: Placebo
• Treatment Sequence 2
  Interventions:

  • Drug: Placebo
  • Drug: PH-797804
• Treatment Sequence 3
  Interventions:

  • Drug: Naproxen
  • Drug: Naproxen + PH-797804
• Treatment Sequence 4
  Interventions:

  • Drug: Naproxen + PH-797804
  • Drug: Naproxen

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 20, 2014): 172
• Original Estimated Enrollment (submitted: April 12, 2010): 190
• Actual Study Completion Date: March 2011
• Actual Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01102660
• Other Study ID Numbers: A6631026
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: August 2014