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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: naproxen
* Drug: CE-224535
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | ongoing | 
| The primary endpoint is the change from Baseline (Day 1) to Week 2 (Day 14) in the WOMAC Pain domain score. |  | Day 1-14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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; |  | (Days 1 to 6) | 
| Patient's Global Impression of Change (PGIC) at Week 2; |  | Week 2 | 
| The change from Baseline to Weeks 1 and 2 in the Patient's Global Assessment of Arthritic Condition; |  | Baseline to Weeks 1 and 2 | 
| The change from Baseline to Week 1 (Day 7) in the WOMAC Pain domain score; |  | Day 7 | 
| The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Stiffness domain score; |  | Days 7 and 14 | 
| The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Physical Function domain score; |  | 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; |  | Days 7 and 14 | 
| The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Importance Weighted Total Score; |  | Days 7 and 14 | 
| The change from Baseline to Weeks 1 and 2 in the Patient's Assessment of Arthritis Pain (VAS) |  | Weeks 1 and 2 |