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A 2 Week Blinded Study For Pain Due To Arthritis Of The Knee

Primary Purpose

Osteoarthritis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxycodone
Placebo
PF-000592379
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female of any race
  • Between the ages of 18 and 75 years
  • Knee Pain due to osteoarthritis

Exclusion Criteria:

  • Pregnant
  • Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to baseline
  • History of malignancy, convulsions, chronic infections, arthroscopy of the worst knee within the past year

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

Oxycodone

Placebo

PF-00592379

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in the pain score averaged over the last week of treatment

Secondary Outcome Measures

Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score - change from baseline to end of treatment
Patient Global Impression of Change
Patients Global Assessment of Osteoarthritis
Pharmacokinetic trough levels

Full Information

First Posted
June 6, 2007
Last Updated
April 22, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00483977
Brief Title
A 2 Week Blinded Study For Pain Due To Arthritis Of The Knee
Official Title
A 2 Week, Randomized, Double Blind, Placebo And Positive Controlled, Parallel Group, Multicentre Study To Assess The Efficacy And Tolerability Of PF-00592379 In Patients With Moderate To Severe Pain Due To Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Terminated
Why Stopped
Met criteria for study futility at interim analysis
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary aim is to assess if PF-00592379 is able to reduce pain in patients with osteoarthritis of the knee.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxycodone
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
PF-00592379
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Oxycodone: oral controlled release, 20 mg, twice a day for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo: oral for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
PF-000592379
Intervention Description
PF-00592379: oral, 30 mg, once a day for 2 weeks
Primary Outcome Measure Information:
Title
Change from baseline in the pain score averaged over the last week of treatment
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score - change from baseline to end of treatment
Time Frame
2 weeks
Title
Patient Global Impression of Change
Time Frame
2 weeks
Title
Patients Global Assessment of Osteoarthritis
Time Frame
2 weeks
Title
Pharmacokinetic trough levels
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 of any race Between the ages of 18 and 75 years Knee Pain due to osteoarthritis Exclusion Criteria: Pregnant Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to baseline History of malignancy, convulsions, chronic infections, arthroscopy of the worst knee within the past year
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
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Pfizer Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Pfizer Investigational Site
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Pfizer Investigational Site
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
Pfizer Investigational Site
City
Orangevale
State/Province
California
ZIP/Postal Code
95662
Country
United States
Facility Name
Pfizer Investigational Site
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Pfizer Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Pfizer Investigational Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Pfizer Investigational Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Pfizer Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Pfizer Investigational Site
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Pfizer Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Pfizer Investigational Site
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
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
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10022-1009
Country
United States
Facility Name
Pfizer Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7771010&StudyName=A%202%20Week%20Blinded%20Study%20For%20Pain%20Due%20To%20Arthritis%20Of%20The%20Knee.
Description
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A 2 Week Blinded Study For Pain Due To Arthritis Of The Knee

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