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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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PH-797804
Placebo
Placebo
PH-797804
Naproxen
Naproxen + PH-797804
Naproxen + PH-797804
Naproxen
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Knee osteoarthritis, clinical trial, cross-over

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Treatment Sequence 1

Treatment Sequence 2

Treatment Sequence 3

Treatment Sequence 4

Arm Description

Outcomes

Primary Outcome Measures

Western Ontario & McMaster Osteoarthritis Index Pain Score

Secondary Outcome Measures

Western Ontario & McMaster Osteoarthritis Index Stiffness Score
Western Ontario & McMaster Osteoarthritis Index Physical Function Score
Western Ontario & McMaster Osteoarthritis Index Total Score
Daily Pain Rating Scale

Full Information

First Posted
April 12, 2010
Last Updated
August 20, 2014
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01102660
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Knee osteoarthritis, clinical trial, cross-over

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Sequence 1
Arm Type
Other
Arm Title
Treatment Sequence 2
Arm Type
Other
Arm Title
Treatment Sequence 3
Arm Type
Other
Arm Title
Treatment Sequence 4
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
PH-797804
Intervention Description
Tablet, 6 mg once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet, 0 mg once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet, 0 mg once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
PH-797804
Intervention Description
Tablet, 6 mg once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
Tablet, 500 mg twice daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Naproxen + PH-797804
Intervention Description
Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Naproxen + PH-797804
Intervention Description
Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
Tablet, 500 mg twice daily for 2 weeks
Primary Outcome Measure Information:
Title
Western Ontario & McMaster Osteoarthritis Index Pain Score
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Western Ontario & McMaster Osteoarthritis Index Stiffness Score
Time Frame
2 weeks
Title
Western Ontario & McMaster Osteoarthritis Index Physical Function Score
Time Frame
2 weeks
Title
Western Ontario & McMaster Osteoarthritis Index Total Score
Time Frame
2 weeks
Title
Daily Pain Rating Scale
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Pfizer Investigational Site
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Pfizer Investigational Site
City
Valley Village
State/Province
California
ZIP/Postal Code
91607
Country
United States
Facility Name
Pfizer Investigational Site
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Pfizer Investigational Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Pfizer Investigational Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Pfizer Investigational Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Pfizer Investigational Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Pfizer Investigational Site
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Pfizer Investigational Site
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Pfizer Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67206
Country
United States
Facility Name
Pfizer Investigational Site
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
Pfizer Investigational Site
City
Hyannis
State/Province
Massachusetts
ZIP/Postal Code
02601
Country
United States
Facility Name
Pfizer Investigational Site
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Pfizer Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Pfizer Investigational Site
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Pfizer Investigational Site
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Pfizer Investigational Site
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Pfizer Investigational Site
City
New Tazewell
State/Province
Tennessee
ZIP/Postal Code
37825
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6631026&StudyName=Clinical%20Trial%20to%20Examine%20the%20Pain%20Relief%20of%20PH-797804%20Alone%20Or%20with%20Naproxen%20in%20Subjects%20with%20Osteoarthritis%20of%20the%20Knee
Description
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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

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