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

Bayer41 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Osteoarthritis, Knee

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)

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (5)

Radiant Research, Inc.

Chandler, Arizona, United States

Radiant Research, Inc.

Pinellas Park, Florida, United States

Radiant Research, Inc.

Chicago, Illinois, United States

Radiant Research, Inc.

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: 4 days

Secondary Outcomes

Absolute Brief Arthritis Stiffness Scale (BASS) Score at Each Time Point

Time frame: 4 days

Change From Baseline in Brief Arthritis Stiffness Scale (BASS) Score at Day 4

Time frame: Day 4

Data from ClinicalTrials.gov

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