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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03570554
• Other study ID #: 19783
• Status: Completed
• Phase: Phase 2
• Start date: June 29, 2018
• Est. completion date: June 14, 2019

Study information

• Verified date: June 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 14, 2019
• Est. primary completion date: June 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Naproxen Sodium (Aleve, BAY117031)
660 mg daily for 3 days, 440 mg on the fourth day, over-encapsulated tablet, oral (Treatment A)
• Acetaminophen ER
3900 mg daily for 3 days, 1300 mg on the fourth day, over-encapsulated extended release (ER) tablet, oral (Treatment B)
• Celecoxib
200 mg daily for 3 days, 100 mg on the fourth day, over-encapsulated capsule, oral (Treatment C)
• Placebo
Over-encapsulation capsule, 4 days, oral (Treatment D)

Locations

Country	Name	City	State
United States	Radiant Research, Inc.	Chandler	Arizona
United States	Radiant Research, Inc.	Chicago	Illinois
United States	Radiant Research, Inc.	Cincinnati	Ohio
United States	Radiant Research, Inc.	Pinellas Park	Florida
United States	Radiant Research, Inc.	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of Change in Brief Arthritis Stiffness Scale (BASS) Scores Over the 4-day Treatment Period	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.	4 days
Secondary	Absolute Brief Arthritis Stiffness Scale (BASS) Score at Each Time Point	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.	4 days
Secondary	Change From Baseline in Brief Arthritis Stiffness Scale (BASS) Score at 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.	Day 4