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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: Naproxen Sodium (Aleve, BAY117031); Drug: Acetaminophen ER; Drug: Celecoxib; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Radiant Research, Inc.
  • Florida
    • Pinellas Park, Florida, United States, 33781
      • Radiant Research, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60602
      • Radiant Research, Inc.
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Radiant Research, Inc.
  • Texas
    • San Antonio, Texas, United States, 78229
      • Radiant Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment A-D-C-B; Participants received naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by placebo for 4 days; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days.	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)
EXPERIMENTAL: Treatment B-C-D-A; Participants received acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by placebo for 4 days; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days.	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)
EXPERIMENTAL: Treatment C-A-B-D; Participants received celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by placebo for 4 days. Treatment periods were separated by a washout period of 3 to 7 days.	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)
EXPERIMENTAL: Treatment D-B-A-C; Participants received placebo for 4 days; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 29, 2018
• Primary Completion (ACTUAL): June 14, 2019
• Study Completion (ACTUAL): June 14, 2019

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (ACTUAL): June 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 19, 2020
• Last Update Submitted That Met QC Criteria: June 3, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Cyclooxygenase 2 Inhibitors; Gout Suppressants; Celecoxib; Acetaminophen; Naproxen
• Other Study ID Numbers: 19783

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No