Trial Condition(s):
Osteoarthritis, Knee
A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale
Bayer Identifier:
19783
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Radiant Research, Inc. San Antonio, United States, 78229 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Radiant Research, Inc. Chicago, United States, 60602 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Radiant Research, Inc. Pinellas Park, United States, 33781 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Radiant Research, Inc. Cincinnati, United States, 45236 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Radiant Research, Inc. Chandler, United States, 85224 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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
Primary Outcome
- Sum of change in Brief Arthritis Stiffness Scale (BASS) scores over the 4-day treatment periodBrief 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.Timeframe: 4 days
Secondary Outcome
- Absolute Brief Arthritis Stiffness Scale (BASS) score at each time pointBrief 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.Timeframe: 4 days
- Change from baseline in Brief Arthritis Stiffness Scale (BASS) score at Day 4Brief 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.Timeframe: 4 days
Additional Information
Not Available
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