A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale

Status:	Recruiting
Conditions:	Arthritis, Osteoarthritis (OA)
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	40 - 80
Updated:	4/6/2019
Start Date:	June 29, 2018
End Date:	May 15, 2019
Contact:	Bayer Clinical Trials Contact
Email:	clinical-trials-contact@bayer.com
Phone:	(+)1-888-84 22937

Osteoarthritis is a common, chronic, progressive, skeletal, degenerative disorder that
frequently affects several joints such as knee, hip, spine and hands.This placebo-controlled
clinical trial will assess the effects of naproxen sodium, acetaminophen and celecoxib on
stiffness in subjects with osteoarthritis.

The primary objective of the study is to assess the responsiveness of the Brief Arthritis
Stiffness Scale (BASS) for detecting treatment effects of common OTC analgesics and a common
prescription analgesic in subjects with knee osteoarthritis.

Inclusion Criteria:

- Age between 40 and 80 years

- Body Mass Index (BMI) between 18 and <40 kg/m2

- Unilateral or bilateral osteoarthritis of the knee

- Diagnostic quality radiograph of the target knee performed no more than 1 year prior
to baseline showing evidence of OA with Kellgren and Lawrence grade of II or III

- Joint Stiffness Severity score ≥3 on a 0-10 NRS at Screening

Exclusion Criteria:

- History of underlying inflammatory arthropathy, rheumatoid arthritis or fibromyalgia

- History of or scheduled for target knee replacement surgery

- Recent injury in target knee (past 4 months)

We found this trial at

sites

Radiant Research, Inc.

Cincinnati, Ohio 45249

from

Cincinnati, OH