Status:

TERMINATED

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

Lead Sponsor:

Pfizer

Conditions:

Osteoarthritis

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

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 t...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2007

Estimated Enrollment :

212 Patients enrolled

Trial Details

Trial ID

NCT00418782

Start Date

January 1 2007

End Date

August 1 2007

Last Update

December 5 2018

Active Locations (46)

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Page 1 of 12 (46 locations)

1

Pfizer Investigational Site

Anniston, Alabama, United States, 36207

2

Pfizer Investigational Site

Bayou La Batre, Alabama, United States, 36509

3

Pfizer Investigational Site

Birmingham, Alabama, United States, 35209

4

Pfizer Investigational Site

Birmingham, Alabama, United States, 35216