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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A-D-C-B | Experimental | 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. |
|
| Treatment B-C-D-A | Experimental | 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. |
|
| Treatment C-A-B-D | Experimental | 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. |
|
| Treatment D-B-A-C | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen Sodium (Aleve, BAY117031) | Drug | 660 mg daily for 3 days, 440 mg on the fourth day, over-encapsulated tablet, oral (Treatment A) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research, Inc. | Chandler | Arizona | 85224 | United States | ||
| Radiant Research, Inc. |
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.
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Overall, 209 participants were screened. Of them, 168 participants were screen failures, and 41 subjects were randomized to study treatments.
Study was conducted at multiple centers in the US between 29 June 2018 (first participant first visit) and 14 June 2019 (last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population: all participants who received at least one dose of investigational medicinal product (IMP).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per-protocol (PP) population: all subjects who were randomly assigned and had taken at least one dose of IMP without major protocol violations that could affect the evaluability of the primary efficacy parameter. | Posted | Least Squares Mean | Standard Error | Scores on a scale | 4 days |
|
After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Naproxen | Participants received naproxen 660 mg daily for 3 days and 440 mg on the fourth day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | 1-888-8422937 | clinical-trials-contact@bayer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 11, 2018 | Jun 3, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 25, 2019 | Jun 3, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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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 |
|
| 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) |
|
| 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 |
| 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 |
| Adverse Event |
|
| BG001 |
| 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Brief Arthritis Stiffness Scale (BASS) | 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. | Participants in safety population with evaluable data for this characteristic | Mean | Standard Deviation | Scores on a scale |
|
| OG001 | Acetaminophen ER | Participants received acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day. |
| OG002 | Celecoxib | Participants received celecoxib 200 mg daily for 3 days and 100 mg on the fourth day. |
| OG003 | Placebo | Participants received placebo for 4 days. |
|
|
| Secondary | 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. | Per-protocol (PP) population: all subjects who were randomly assigned and had taken at least one dose of IMP without major protocol violations that could affect the evaluability of the primary efficacy parameter. | Posted | Least Squares Mean | Standard Error | Scores on a scale | 4 days |
|
|
|
| Secondary | 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. | Per-protocol (PP) population: All subjects who were randomly assigned and had taken at least one dose of IMP without major protocol violations that could affect the evaluability of the primary efficacy parameter. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Day 4 |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 5 |
| 39 |
| EG001 | Acetaminophen ER | Participants received acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day | 0 | 40 | 0 | 40 | 8 | 40 |
| EG002 | Celecoxib | Participants received celecoxib 200 mg daily for 3 days and 100 mg on the fourth day | 0 | 40 | 0 | 40 | 10 | 40 |
| EG003 | Placebo | Participants received placebo for 4 days | 0 | 39 | 0 | 39 | 3 | 39 |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA (21.1) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (21.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (21.1) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
|
| Heart rate decreased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
|
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| D012216 |
| Rheumatic Diseases |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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| Day 2 |
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| Day 3 |
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| Day 4 |
|