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

This study has been terminated.
(Results of interim analysis indicate lack of efficacy when compared to placebo.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00418782
First received: January 4, 2007
Last updated: February 29, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Drug: naproxen
Drug: CE-224535
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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 [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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; [ Time Frame: (Days 1 to 6) ] [ Designated as safety issue: No ]
  • Patient's Global Impression of Change (PGIC) at Week 2; [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The change from Baseline to Week 1 (Day 7) in the WOMAC Pain domain score; [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The change from Baseline to Weeks 1 and 2 in the Patient's Assessment of Arthritis Pain (VAS) [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]

Estimated Enrollment: 212
Study Start Date: January 2007
Estimated Study Completion Date: August 2007
Arms Assigned Interventions
Active Comparator: 1 Drug: naproxen
Experimental: 2 Drug: CE-224535
Placebo Comparator: 3 Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418782

  Show 46 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00418782     History of Changes
Other Study ID Numbers: A6341008
Study First Received: January 4, 2007
Last Updated: February 29, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014