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

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ClinicalTrials.gov Identifier: NCT00418782
Recruitment Status : Terminated (Results of interim analysis indicate lack of efficacy when compared to placebo.)
First Posted : January 5, 2007
Last Update Posted : March 3, 2008
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: naproxen Drug: CE-224535 Drug: placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2007
Estimated Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. 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) ]
  2. Patient's Global Impression of Change (PGIC) at Week 2; [ Time Frame: Week 2 ]
  3. 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 ]
  4. The change from Baseline to Week 1 (Day 7) in the WOMAC Pain domain score; [ Time Frame: Day 7 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. The change from Baseline to Weeks 1 and 2 in the Patient's Assessment of Arthritis Pain (VAS) [ Time Frame: Weeks 1 and 2 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00418782

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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00418782     History of Changes
Other Study ID Numbers: A6341008
First Posted: January 5, 2007    Key Record Dates
Last Update Posted: March 3, 2008
Last Verified: February 2008

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