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A Study Of The Effect Of CE-224535 On Knee OA (Osteoarthritis) Pain

Primary Purpose

Osteoarthritis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
naproxen
CE-224535
placebo
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:

  • Is a healthy adult 18 to 75 years of age, inclusive, in general good health and with diagnosis of knee OA, as determined by the American College of Rheumatology (ACR) clinical/radiographic classification criteria for OA of the knee.
  • Women must be of non childbearing potential (amenorrhea for at least 1 year PLUS have a serum follicle stimulating hormone (FSH) level >30 IU/L, bilateral oophorectomy or hysterectomy), and have a confirmed negative serum pregnancy test at the screening visit prior to randomization.

Exclusion Criteria:

  • History of other diseases that may involve the study joint, including inflammatory joint diseases, crystalline disease, endocrinopathies, metabolic diseases, infections, neuropathic disorders, avascular necrosis, Paget's disease, or tumors.
  • Women of childbearing potential, or who are pregnant or lactating.

Sites / Locations

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

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

To determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of oral multiple doses of CE 224,535 in subjects with OA of the knee
The primary endpoint is the change from Baseline (Day 1) to Week 2 (Day 14) in the WOMAC Pain domain score.

Secondary Outcome Measures

The change from Baseline to each day (Days 1 to 6) and over the average response in Days 1 to 6 using an 11 point numeric rating scale (NRS) from 0-10 on daily pain diary;
Patient's Global Impression of Change (PGIC) at Week 2;
The change from Baseline to Weeks 1 and 2 in the Patient's Global Assessment of Arthritic Condition;
The change from Baseline to Week 1 (Day 7) in the WOMAC Pain domain score;
The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Stiffness domain score;
The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Physical Function domain score;
The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Total Score by simple summation;
The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Importance Weighted Total Score;
The change from Baseline to Weeks 1 and 2 in the Patient's Assessment of Arthritis Pain (VAS)

Full Information

First Posted
January 4, 2007
Last Updated
December 3, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00418782
Brief Title
A Study Of The Effect Of CE-224535 On Knee OA (Osteoarthritis) Pain
Official Title
A 2 Week, Randomized, Double Blind, Placebo And Positive Controlled, Parallel Group, Multicenter Study Of CE-224,535 In Subjects With Osteoarthritic Pain Of The Knee
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Results of interim analysis indicate lack of efficacy when compared to placebo.
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
CE-224535 is a new medication being developed as an analgesic and anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to evaluate the analgesic and anti inflammatory efficacy and safety of CE 224,535 versus placebo and naproxen treatment in patients with OA knee pain.

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
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
naproxen
Intervention Type
Drug
Intervention Name(s)
CE-224535
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
To determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of oral multiple doses of CE 224,535 in subjects with OA of the knee
Time Frame
ongoing
Title
The primary endpoint is the change from Baseline (Day 1) to Week 2 (Day 14) in the WOMAC Pain domain score.
Time Frame
Day 1-14
Secondary Outcome Measure Information:
Title
The change from Baseline to each day (Days 1 to 6) and over the average response in Days 1 to 6 using an 11 point numeric rating scale (NRS) from 0-10 on daily pain diary;
Time Frame
(Days 1 to 6)
Title
Patient's Global Impression of Change (PGIC) at Week 2;
Time Frame
Week 2
Title
The change from Baseline to Weeks 1 and 2 in the Patient's Global Assessment of Arthritic Condition;
Time Frame
Baseline to Weeks 1 and 2
Title
The change from Baseline to Week 1 (Day 7) in the WOMAC Pain domain score;
Time Frame
Day 7
Title
The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Stiffness domain score;
Time Frame
Days 7 and 14
Title
The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Physical Function domain score;
Time Frame
Days 7 and 14
Title
The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Total Score by simple summation;
Time Frame
Days 7 and 14
Title
The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Importance Weighted Total Score;
Time Frame
Days 7 and 14
Title
The change from Baseline to Weeks 1 and 2 in the Patient's Assessment of Arthritis Pain (VAS)
Time Frame
Weeks 1 and 2

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: Is a healthy adult 18 to 75 years of age, inclusive, in general good health and with diagnosis of knee OA, as determined by the American College of Rheumatology (ACR) clinical/radiographic classification criteria for OA of the knee. Women must be of non childbearing potential (amenorrhea for at least 1 year PLUS have a serum follicle stimulating hormone (FSH) level >30 IU/L, bilateral oophorectomy or hysterectomy), and have a confirmed negative serum pregnancy test at the screening visit prior to randomization. Exclusion Criteria: History of other diseases that may involve the study joint, including inflammatory joint diseases, crystalline disease, endocrinopathies, metabolic diseases, infections, neuropathic disorders, avascular necrosis, Paget's disease, or tumors. Women of childbearing potential, or who are pregnant or lactating.
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
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Pfizer Investigational Site
City
Bayou La Batre
State/Province
Alabama
ZIP/Postal Code
36509
Country
United States
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Pfizer Investigational Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Pfizer Investigational Site
City
Northridge
State/Province
California
ZIP/Postal Code
91325
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
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Pfizer Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Pfizer Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Pfizer Investigational Site
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80030
Country
United States
Facility Name
Pfizer Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Pfizer Investigational Site
City
DeFuniak Springs
State/Province
Florida
ZIP/Postal Code
32435
Country
United States
Facility Name
Pfizer Investigational Site
City
Destin
State/Province
Florida
ZIP/Postal Code
32541
Country
United States
Facility Name
Pfizer Investigational Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60053
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
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Pfizer Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Pfizer Investigational Site
City
Gretna
State/Province
Louisiana
ZIP/Postal Code
70056
Country
United States
Facility Name
Pfizer Investigational Site
City
Kenner
State/Province
Louisiana
ZIP/Postal Code
70065
Country
United States
Facility Name
Pfizer Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70002
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Pfizer Investigational Site
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Pfizer Investigational Site
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Pfizer Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Pfizer Investigational Site
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Pfizer Investigational Site
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
Facility Name
Pfizer Investigational Site
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45440
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
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Pfizer Investigational Site
City
Ashland
State/Province
Oregon
ZIP/Postal Code
97520
Country
United States
Facility Name
Pfizer Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Pfizer Investigational Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Pfizer Investigational Site
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Pfizer Investigational Site
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Facility Name
Pfizer Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909-1900
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Pfizer Investigational Site
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Pfizer Investigational Site
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pfizer Investigational Site
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Pfizer Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6341008&StudyName=A%20Study%20Of%20The%20Effect%20Of%20CE-224535%20On%20Knee%20OA%20%28Osteoarthritis%29%20Pain
Description
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A Study Of The Effect Of CE-224535 On Knee OA (Osteoarthritis) Pain

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