check_circleStudy Completed

Osteoarthritis, Knee

Bayer Identifier:

19783

ClinicalTrials.gov Identifier:

NCT03570554

EudraCT Number:

Not Available

EU CT Number:

Not Available
A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale

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.

Key Participants Requirements

Sex

All

Age

40 - 80 Years
  • - 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
  • - 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
June 2018 - June 2019
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Aleve (Naproxen Sodium, BAY117031)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Radiant Research, Inc.San Antonio, 78229, United States
Completed
Radiant Research, Inc.Chicago, 60602, United States
Completed
Radiant Research, Inc.Pinellas Park, 33781, United States
Completed
Radiant Research, Inc.Cincinnati, 45236, United States
Completed
Radiant Research, Inc.Chandler, 85224, United States

Primary Outcome

  • Sum of change in Brief Arthritis Stiffness Scale (BASS) scores over the 4-day treatment period
    Brief Arthritis Stiffness Scale (BASS) is a patient-reported outcome (PRO) instrument measuring of the severity of osteoarthritis-related stiffness in the target knee joint. The BASS score ranges from 0 to 40 and a higher score indicates worse stiffness. This endpoint was calculated by summing the changes from baseline (CFB) in BASS scores at Days 2, 3, and 4 of the treatment periods.
    date_rangeTime Frame:
    4 days

Secondary Outcome

  • Absolute Brief Arthritis Stiffness Scale (BASS) score at each time point
    Brief Arthritis Stiffness Scale (BASS) is a patient-reported outcome (PRO) instrument measuring of the severity of osteoarthritis-related stiffness in the target knee joint. The BASS score ranges from 0 to 40 and a higher score indicates worse stiffness.
    date_rangeTime Frame:
    4 days
  • Change from baseline in Brief Arthritis Stiffness Scale (BASS) score at Day 4
    Brief Arthritis Stiffness Scale (BASS) is a patient-reported outcome (PRO) instrument measuring of the severity of osteoarthritis-related stiffness in the target knee joint. The BASS score ranges from 0 to 40 and a higher score indicates worse stiffness.
    date_rangeTime Frame:
    4 days

Trial design

A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
4