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A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-04457845
PF-04457845
Naproxen
Naproxen
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Cross-over evaluate the efficacy of PF-04457845 in relieving pain due to osteoarthritis OA knee osteoarthritis of knee pain due to osteoarthritis

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects must have a diagnosis of Osteoarthritis (OA) of the knee confirmed by X-ray
  • Subjects must be willing and able to stop all current pain therapy for the duration of study. (Limited and specific pain therapy will be available throughout the study)
  • Subjects can be male or female between the ages of 18 and 75 years inclusive, but female subjects must not be able become pregnant

Exclusion Criteria:

  • Subjects must not have any condition or medical history that might interfere with their ability to complete the study assessments

Sites / Locations

  • Arthritis & Rheumatic Care Center
  • Miami Research Associates
  • Vince and Associates Clinical Research
  • Vince and Associates Clinical Research
  • CEDRA Clinical Research, LLC
  • Diex Research Inc.
  • Centrum for klinisk provning

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

PF-04457845 followed by placebo

Placebo followed by PF-04457845

Naproxen followed by placebo

Placebo followed by Naproxen

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the efficacy of PF-04457845 (administered QD) versus placebo in relieving pain as measured by the WOMAC Pain sub-score in patients with osteoarthritis of the knee
To evaluate the safety and tolerability of PF-04457845 in patients with osteoarthritis.

Secondary Outcome Measures

Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Stiffness domain score (Likert scale for 2 items, overall score ranges from 0-8) in patients with osteoarthritis of the knee.
Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Physical Function domain score (Likert scale for 17 items, overall score ranges from 0-68) in patients with osteoarthritis of the knee.
Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Total Score in patients with osteoarthritis of the knee.
Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Importance weighted Total WOMAC score in patients with osteoarthritis of the knee.
Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Daily pain diary over weeks 1 and 2 of each treatment period using an 11-point Numeric Rating Scale (NRS) in patients with osteoarthritis of the knee.
Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Subjects' use of rescue medication on either treatment.
Summary of plasma concentrations of PF-04457845.
Residual FAAH activity in leukocytes for subjects recruited prior to the interim analysis.
Plasma fatty acid amide levels (OEA, PEA, LEA and AEA) for subjects recruited prior to the interim analysis.

Full Information

First Posted
September 21, 2009
Last Updated
September 13, 2017
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00981357
Brief Title
A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee
Official Title
A Phase 2a Randomized, Double-blinded, Double Dummy, Placebo And Active Controlled, Two-way Cross-over, Flare-enriched Multi-centre Clinical Trial To Examine The Pain Relief Produced By 2 Weeks Of Daily Oral Administration Of A Fatty Acid Amide Hydrolase (Faah) Inhibitor Pf-04457845 In Patients With Osteoarthritis Of The Knee.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2009 (Actual)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Inactivation of the FAAH (Fatty Acid Amide Hydrolase) enzyme has been shown to relieve pain and inflammation in animal studies. PF-04457845 has been shown to inactivate the FAAH enzyme in animals and healthy human volunteers. The purpose of this study is to evaluate whether PF-04457845 can inactivate the FAAH enzyme in patients experiencing pain due to OA and whether this results in these patients experiencing less pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Cross-over evaluate the efficacy of PF-04457845 in relieving pain due to osteoarthritis OA knee osteoarthritis of knee pain due to osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-04457845 followed by placebo
Arm Type
Experimental
Arm Title
Placebo followed by PF-04457845
Arm Type
Experimental
Arm Title
Naproxen followed by placebo
Arm Type
Active Comparator
Arm Title
Placebo followed by Naproxen
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
PF-04457845
Intervention Description
PF-04457845 4 mg tablet once daily / matched placebo
Intervention Type
Drug
Intervention Name(s)
PF-04457845
Intervention Description
PF-04457845 4 mg tablet once daily / matched placebo
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
Naproxen 500 mg tablet twice daily / matched placebo
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
Naproxen 500 mg tablet twice daily / matched placebo
Primary Outcome Measure Information:
Title
To evaluate the efficacy of PF-04457845 (administered QD) versus placebo in relieving pain as measured by the WOMAC Pain sub-score in patients with osteoarthritis of the knee
Time Frame
8 weeks
Title
To evaluate the safety and tolerability of PF-04457845 in patients with osteoarthritis.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Stiffness domain score (Likert scale for 2 items, overall score ranges from 0-8) in patients with osteoarthritis of the knee.
Time Frame
8 weeks
Title
Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Physical Function domain score (Likert scale for 17 items, overall score ranges from 0-68) in patients with osteoarthritis of the knee.
Time Frame
8 weeks
Title
Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Total Score in patients with osteoarthritis of the knee.
Time Frame
8 weeks
Title
Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Importance weighted Total WOMAC score in patients with osteoarthritis of the knee.
Time Frame
8 weeks
Title
Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Daily pain diary over weeks 1 and 2 of each treatment period using an 11-point Numeric Rating Scale (NRS) in patients with osteoarthritis of the knee.
Time Frame
8 weeks
Title
Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Subjects' use of rescue medication on either treatment.
Time Frame
8 weeks
Title
Summary of plasma concentrations of PF-04457845.
Time Frame
8 weeks
Title
Residual FAAH activity in leukocytes for subjects recruited prior to the interim analysis.
Time Frame
8 weeks
Title
Plasma fatty acid amide levels (OEA, PEA, LEA and AEA) for subjects recruited prior to the interim analysis.
Time Frame
8 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: Subjects must have a diagnosis of Osteoarthritis (OA) of the knee confirmed by X-ray Subjects must be willing and able to stop all current pain therapy for the duration of study. (Limited and specific pain therapy will be available throughout the study) Subjects can be male or female between the ages of 18 and 75 years inclusive, but female subjects must not be able become pregnant Exclusion Criteria: Subjects must not have any condition or medical history that might interfere with their ability to complete the study assessments
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
Arthritis & Rheumatic Care Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Vince and Associates Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Vince and Associates Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
CEDRA Clinical Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Diex Research Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Centrum for klinisk provning
City
Goteborg
ZIP/Postal Code
405 30
Country
Sweden

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0541004&StudyName=A%20Study%20To%20Investigate%20Whether%20PF-04457845%20Is%20Effective%20In%20Treating%20Pain%2C%20Is%20Safe%20And%20Tolerable%20In%20Patients%20With%20Osteoarthritis%20Of%20T
Description
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A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee

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