A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale
1 other identifier
interventional
41
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2018
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2018
CompletedFirst Posted
Study publicly available on registry
June 27, 2018
CompletedStudy Start
First participant enrolled
June 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2019
CompletedResults Posted
Study results publicly available
June 19, 2020
CompletedJune 19, 2020
June 1, 2020
12 months
June 18, 2018
June 3, 2020
June 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Absolute Brief Arthritis Stiffness Scale (BASS) Score at Each Time Point
4 days
Change From Baseline in Brief Arthritis Stiffness Scale (BASS) Score at Day 4
Day 4
Study Arms (4)
Treatment A-D-C-B
EXPERIMENTALParticipants 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.
Treatment B-C-D-A
EXPERIMENTALParticipants 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.
Treatment C-A-B-D
EXPERIMENTALParticipants 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.
Treatment D-B-A-C
EXPERIMENTALParticipants 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
Interventions
660 mg daily for 3 days, 440 mg on the fourth day, over-encapsulated tablet, oral (Treatment A)
3900 mg daily for 3 days, 1300 mg on the fourth day, over-encapsulated extended release (ER) tablet, oral (Treatment B)
200 mg daily for 3 days, 100 mg on the fourth day, over-encapsulated capsule, oral (Treatment C)
Over-encapsulation capsule, 4 days, oral (Treatment D)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (5)
Radiant Research, Inc.
Chandler, Arizona, 85224, United States
Radiant Research, Inc.
Pinellas Park, Florida, 33781, United States
Radiant Research, Inc.
Chicago, Illinois, 60602, United States
Radiant Research, Inc.
Cincinnati, Ohio, 45236, United States
Radiant Research, Inc.
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2018
First Posted
June 27, 2018
Study Start
June 29, 2018
Primary Completion
June 14, 2019
Study Completion
June 14, 2019
Last Updated
June 19, 2020
Results First Posted
June 19, 2020
Record last verified: 2020-06