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

Study 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 will assess the effects of naproxen sodium, acetaminophen and celecoxib on stiffness in subjects with osteoarthritis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age between 40 and 80 years - Body Mass Index (BMI) between 18 and <40 kg/m2 - Unilateral or bilateral osteoarthritis of the knee - Diagnostic quality radiograph of the target knee performed no more than 1 year prior to baseline showing evidence of OA with Kellgren and Lawrence grade of II or III - Joint Stiffness Severity score ≥3 on a 0-10 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03570554
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bayer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Knee
Additional Details

The primary objective of the study is to assess the responsiveness of the Brief Arthritis Stiffness Scale (BASS) for detecting treatment effects of common OTC analgesics and a common prescription analgesic in subjects with knee osteoarthritis.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Radiant Research, Inc., Chandler, Arizona

Status

Recruiting

Address

Radiant Research, Inc.

Chandler, Arizona, 85224

Radiant Research, Inc., Pinellas Park, Florida

Status

Recruiting

Address

Radiant Research, Inc.

Pinellas Park, Florida, 33781

Radiant Research, Inc., Chicago, Illinois

Status

Recruiting

Address

Radiant Research, Inc.

Chicago, Illinois, 60602

Radiant Research, Inc., Cincinnati, Ohio

Status

Recruiting

Address

Radiant Research, Inc.

Cincinnati, Ohio, 45236

Radiant Research, Inc., San Antonio, Texas

Status

Completed

Address

Radiant Research, Inc.

San Antonio, Texas, 78229