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Completed

NCT Number: NCT03570554

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Radiant Research, Inc., Chandler, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Naproxen Sodium (Aleve, BAY117031)

Drug

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

Acetaminophen ER

Drug

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

Celecoxib

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Sum of Change in Brief Arthritis Stiffness Scale (BASS) Scores Over the 4-day Treatment Period

    Time frame: 4 days

    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.

Secondary outcomes

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

    Time frame: 4 days

    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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 27, 2018
Registry last updated
Jun 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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