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

December 3, 2018 updated by: Pfizer

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pfizer Investigational Site
      • Bayou La Batre, Alabama, United States, 36509
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35209
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35242
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35216
        • Pfizer Investigational Site
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Pfizer Investigational Site
    • California
      • Northridge, California, United States, 91325
        • Pfizer Investigational Site
      • Sacramento, California, United States, 95825
        • Pfizer Investigational Site
      • Tarzana, California, United States, 91356
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80206
        • Pfizer Investigational Site
      • Denver, Colorado, United States, 80204
        • Pfizer Investigational Site
      • Westminster, Colorado, United States, 80030
        • Pfizer Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33761
        • Pfizer Investigational Site
      • DeFuniak Springs, Florida, United States, 32435
        • Pfizer Investigational Site
      • Destin, Florida, United States, 32541
        • Pfizer Investigational Site
      • Pensacola, Florida, United States, 32503
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60053
        • Pfizer Investigational Site
      • Gurnee, Illinois, United States, 60031
        • Pfizer Investigational Site
    • Indiana
      • Avon, Indiana, United States, 46123
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46250
        • Pfizer Investigational Site
    • Louisiana
      • Gretna, Louisiana, United States, 70056
        • Pfizer Investigational Site
      • Kenner, Louisiana, United States, 70065
        • Pfizer Investigational Site
      • Metairie, Louisiana, United States, 70002
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Pfizer Investigational Site
      • Frederick, Maryland, United States, 21702
        • Pfizer Investigational Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Pfizer Investigational Site
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Pfizer Investigational Site
      • Kansas City, Missouri, United States, 64114
        • Pfizer Investigational Site
    • Montana
      • Missoula, Montana, United States, 59802
        • Pfizer Investigational Site
    • New Jersey
      • Trenton, New Jersey, United States, 08611
        • Pfizer Investigational Site
    • Ohio
      • Beavercreek, Ohio, United States, 45440
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45242
        • Pfizer Investigational Site
      • Kettering, Ohio, United States, 45429
        • Pfizer Investigational Site
    • Oregon
      • Ashland, Oregon, United States, 97520
        • Pfizer Investigational Site
      • Eugene, Oregon, United States, 97404
        • Pfizer Investigational Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Pfizer Investigational Site
    • South Carolina
      • Summerville, South Carolina, United States, 29485
        • Pfizer Investigational Site
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • Pfizer Investigational Site
      • Knoxville, Tennessee, United States, 37909-1900
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38104
        • Pfizer Investigational Site
    • Texas
      • Bryan, Texas, United States, 77802
        • Pfizer Investigational Site
      • Longview, Texas, United States, 75605
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78213
        • Pfizer Investigational Site
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Pfizer Investigational Site
    • Washington
      • Spokane, Washington, United States, 99216
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: CE-224535
Active Comparator: 1
Drug: naproxen
Placebo Comparator: 3
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
ongoing
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
Day 1-14

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
(Days 1 to 6)
Patient's Global Impression of Change (PGIC) at Week 2;
Time Frame: Week 2
Week 2
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
Baseline to Weeks 1 and 2
The change from Baseline to Week 1 (Day 7) in the WOMAC Pain domain score;
Time Frame: Day 7
Day 7
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
Days 7 and 14
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
Days 7 and 14
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
Days 7 and 14
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
Days 7 and 14
The change from Baseline to Weeks 1 and 2 in the Patient's Assessment of Arthritis Pain (VAS)
Time Frame: Weeks 1 and 2
Weeks 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

January 4, 2007

First Submitted That Met QC Criteria

January 4, 2007

First Posted (Estimate)

January 5, 2007

Study Record Updates

Last Update Posted (Actual)

December 5, 2018

Last Update Submitted That Met QC Criteria

December 3, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6341008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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