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

• ClinicalTrials.gov Identifier: NCT03570554
• Recruitment Status: Completed
• First Posted: June 27, 2018
• Results First Posted: June 19, 2020
• Last Update Posted: June 19, 2020
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis, Knee	Drug: Naproxen Sodium (Aleve, BAY117031); Drug: Acetaminophen ER; Drug: Celecoxib; Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale
• Actual Study Start Date: June 29, 2018
• Actual Primary Completion Date: June 14, 2019
• Actual Study Completion Date: June 14, 2019

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

United States, Arizona

Radiant Research, Inc.

Chandler, Arizona, United States, 85224

United States, Florida

Radiant Research, Inc.

Pinellas Park, Florida, United States, 33781

United States, Illinois

Radiant Research, Inc.

Chicago, Illinois, United States, 60602

United States, Ohio

Radiant Research, Inc.

Cincinnati, Ohio, United States, 45236

United States, Texas

Radiant Research, Inc.

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Bayer

  Study Documents (Full-Text)

Documents provided by Bayer:

Study Protocol  [PDF] September 11, 2018

Statistical Analysis Plan  [PDF] September 25, 2019

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03570554
• Other Study ID Numbers: 19783
• First Posted: June 27, 2018
• Results First Posted: June 19, 2020
• Last Update Posted: June 19, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

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.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Acetaminophen; Celecoxib; Naproxen; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Gout Suppressants