Adults 40 to 80, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Sum of Change in Brief Arthritis Stiffness Scale (BASS) Scores Over the 4-day Treatment PeriodPrimary· 4 days
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.
Group
Value
95% CI
Naproxen
-12.6
± 5.46
Acetaminophen ER
-13.6
± 5.46
Celecoxib
-11.7
± 5.46
Placebo
-2.3
± 5.47
Absolute Brief Arthritis Stiffness Scale (BASS) Score at Each Time PointSecondary· 4 days
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.
Day 1
Group
Value
95% CI
Naproxen
23.0
± 1.84
Acetaminophen ER
23.3
± 1.84
Celecoxib
24.6
± 1.84
Placebo
22.6
± 1.85
Day 2
Group
Value
95% CI
Naproxen
20.8
± 1.62
Acetaminophen ER
19.7
± 1.62
Celecoxib
20.6
± 1.62
Placebo
23.2
± 1.62
Day 3
Group
Value
95% CI
Naproxen
18.4
± 1.97
Acetaminophen ER
18.4
± 1.97
Celecoxib
18.9
± 1.98
Placebo
22.4
± 1.98
Day 4
Group
Value
95% CI
Naproxen
18.1
± 1.97
Acetaminophen ER
18.0
± 1.97
Celecoxib
18.5
± 1.97
Placebo
22.0
± 1.97
Change From Baseline in Brief Arthritis Stiffness Scale (BASS) Score at Day 4Secondary· 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.
Group
Value
95% CI
Naproxen
-5.2
± 1.97
Acetaminophen ER
-5.3
± 1.97
Celecoxib
-4.8
± 1.97
Placebo
-1.3
± 1.97
Adverse events — posted to ClinicalTrials.gov
Time frame: After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Other trials of Naproxen Sodium (Aleve, BAY117031)
Trials testing the same drug.
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Other recruiting trials for Osteoarthritis, Knee
Currently open trials in the same condition.
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· Phase 3
· recruiting
NCT06488144 — Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans
· Phase 3
· recruiting
NCT07386561 — Virtual Reality Therapy and Non-Sleep Deep Rest Relaxation After Joint Arthroplasty
· NA
· active not recruiting
NCT07514598 — Effect of J-Shaped Incision After Total Knee Arthroplasty (J-TKA)
· NA
· active not recruiting
NCT07058623 — Nurse-Led Telehealth vs In-Person Follow-Up After Total Knee Replacement
· NA
· recruiting
Other Bayer trials
Trials by the same sponsor.
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· not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt
· not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About
· not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child
· Phase 3
· not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo
· Phase 2
· not yet recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 19 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03570554.