Phase 2
N=41
A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale
Osteoarthritis, Knee
Bottom Line
View on ClinicalTrials.gov: NCT03570554 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Sum of Change in Brief Arthritis Stiffness Scale (BASS) Scores Over the 4-day Treatment Period — -12.6; -13.6; -11.7; -2.3 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Naproxen Sodium (Aleve, BAY117031) (Drug); Acetaminophen ER (Drug); Celecoxib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum of Change in Brief Arthritis Stiffness Scale (BASS) Scores Over the 4-day Treatment Period |
-12.6; -13.6; -11.7; -2.3 | — |
| SECONDARY Absolute Brief Arthritis Stiffness Scale (BASS) Score at Each Time Point |
23.0; 23.3; 24.6; 22.6; 20.8; 19.7 | — |
| SECONDARY Change From Baseline in Brief Arthritis Stiffness Scale (BASS) Score at Day 4 |
-5.2; -5.3; -4.8; -1.3 | — |
Summary
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03570554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.