A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale
NCT ID: NCT03570554
Last Updated: 2020-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
41 participants
INTERVENTIONAL
2018-06-29
2019-06-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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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.
Naproxen Sodium (Aleve, BAY117031)
660 mg daily for 3 days, 440 mg on the fourth day, over-encapsulated tablet, oral (Treatment A)
Acetaminophen ER
3900 mg daily for 3 days, 1300 mg on the fourth day, over-encapsulated extended release (ER) tablet, oral (Treatment B)
Celecoxib
200 mg daily for 3 days, 100 mg on the fourth day, over-encapsulated capsule, oral (Treatment C)
Placebo
Over-encapsulation capsule, 4 days, oral (Treatment D)
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.
Naproxen Sodium (Aleve, BAY117031)
660 mg daily for 3 days, 440 mg on the fourth day, over-encapsulated tablet, oral (Treatment A)
Acetaminophen ER
3900 mg daily for 3 days, 1300 mg on the fourth day, over-encapsulated extended release (ER) tablet, oral (Treatment B)
Celecoxib
200 mg daily for 3 days, 100 mg on the fourth day, over-encapsulated capsule, oral (Treatment C)
Placebo
Over-encapsulation capsule, 4 days, oral (Treatment D)
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.
Naproxen Sodium (Aleve, BAY117031)
660 mg daily for 3 days, 440 mg on the fourth day, over-encapsulated tablet, oral (Treatment A)
Acetaminophen ER
3900 mg daily for 3 days, 1300 mg on the fourth day, over-encapsulated extended release (ER) tablet, oral (Treatment B)
Celecoxib
200 mg daily for 3 days, 100 mg on the fourth day, over-encapsulated capsule, oral (Treatment C)
Placebo
Over-encapsulation capsule, 4 days, oral (Treatment D)
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
Naproxen Sodium (Aleve, BAY117031)
660 mg daily for 3 days, 440 mg on the fourth day, over-encapsulated tablet, oral (Treatment A)
Acetaminophen ER
3900 mg daily for 3 days, 1300 mg on the fourth day, over-encapsulated extended release (ER) tablet, oral (Treatment B)
Celecoxib
200 mg daily for 3 days, 100 mg on the fourth day, over-encapsulated capsule, oral (Treatment C)
Placebo
Over-encapsulation capsule, 4 days, oral (Treatment D)
Interventions
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Naproxen Sodium (Aleve, BAY117031)
660 mg daily for 3 days, 440 mg on the fourth day, over-encapsulated tablet, oral (Treatment A)
Acetaminophen ER
3900 mg daily for 3 days, 1300 mg on the fourth day, over-encapsulated extended release (ER) tablet, oral (Treatment B)
Celecoxib
200 mg daily for 3 days, 100 mg on the fourth day, over-encapsulated capsule, oral (Treatment C)
Placebo
Over-encapsulation capsule, 4 days, oral (Treatment D)
Eligibility Criteria
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Inclusion Criteria
* 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 or scheduled for target knee replacement surgery
* Recent injury in target knee (past 4 months)
40 Years
80 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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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
Radiant Research, Inc.
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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19783
Identifier Type: -
Identifier Source: org_study_id
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