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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00418782

Enrollment

212

Registered

2007-01-05

Start date

2007-01-31

Completion date

2007-08-31

Last updated

2018-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

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.

Interventions

DRUGnaproxen

DRUGCE-224535

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Measure	Time frame
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 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)
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
The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Physical Function domain score;	Days 7 and 14
Patient's Global Impression of Change (PGIC) at Week 2;	Week 2

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026