Trial Condition(s):

Osteoarthritis, Knee

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

Bayer Identifier:

19783

ClinicalTrials.gov Identifier:

NCT03570554

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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 assessed the effects of naproxen sodium, acetaminophen and celecoxib on stiffness in subjects with osteoarthritis.

Inclusion Criteria
- Age between 40 and 80 years
 - Body Mass Index (BMI) between 18 and <40 kg/m^2
 - Unilateral or bilateral osteoarthritis of the knee
 - Diagnostic quality radiography of the target knee performed no more than 1 year prior to baseline showing evidence of osteoarthritis (OA) with Kellgren and Lawrence grade of II or III
 - Joint Stiffness Severity score ≥3.0 on a 0-10 numerical rating scale (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)

Trial Summary

Enrollment Goal
41
Trial Dates
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Phase
2
Could I receive a placebo?
Yes
Products
Aleve (Naproxen Sodium, BAY117031)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Radiant Research, Inc.

San Antonio, United States, 78229

Status
Completed
 
Locations

Radiant Research, Inc.

Chicago, United States, 60602

Status
Completed
 
Locations

Radiant Research, Inc.

Pinellas Park, United States, 33781

Status
Completed
 
Locations

Radiant Research, Inc.

Cincinnati, United States, 45236

Status
Completed
 
Locations

Radiant Research, Inc.

Chandler, United States, 85224

Status
Completed
 

Trial Design