CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
Naproxen Sodium (Aleve, BAY117031) +3 moredrug
Likely dose
Naproxen Sodium (Aleve, BAY117031) 660 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03570554
NCT03570554Phase 2Completed
CompareCT.gov

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

Bayer·interventional·Posted Jun 27, 2018·Updated Jun 19, 2020

In Brief

A Phase 2 clinical trial evaluating Naproxen Sodium (Aleve, BAY117031), Acetaminophen ER, and 2 other interventions for Osteoarthritis, Knee. Completed, enrolled 41 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJun 27, 2018
Enrollment StartJun 29, 2018
Primary CompletionJun 14, 2019
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.0 years ago

Interventions

Naproxen Sodium (Aleve, BAY117031)drug

660 mg daily for 3 days, 440 mg on the fourth day, over-encapsulated tablet, oral (Treatment A)

Acetaminophen ERdrug

3900 mg daily for 3 days, 1300 mg on the fourth day, over-encapsulated extended release (ER) tablet, oral (Treatment B)

Celecoxibdrug

200 mg daily for 3 days, 100 mg on the fourth day, over-encapsulated capsule, oral (Treatment C)

Placebodrug

Over-encapsulation capsule, 4 days, oral (Treatment D)