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

Phase 2

Terminated

• Conditions: Osteoarthritis
• Interventions: Drug: naproxen; Drug: placebo; Drug: CE-224535

• Registration Number: NCT00418782
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-04
• Study First Submitted QC: 2007-01-04
• Study First Posted: 2007-01-05
• Study Completion: 2007-08
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-03
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 212

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	naproxen	-
3	placebo	-
2	CE-224535	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 Physical Function domain 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
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 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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Spokane, Washington, United States