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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Paramount, California, 90723 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01102660
Pfizer
Completed
Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee

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Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Osteoarthritis
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
March 2011
February 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01102660
A6631026
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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