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

NCT03570554 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2020-06-19

Study results available
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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.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Naproxen Sodium (Aleve, BAY117031)

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

DRUG

Acetaminophen ER

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

DRUG

Celecoxib

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

DRUG

Placebo

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-29
Primary Completion
2019-06-14
Completion
2019-06-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03570554 on ClinicalTrials.gov