Osteoarthritis, KneePhase 2NCT03570554

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

A Phase 2 study testing Naproxen Sodium (Aleve, BAY117031), Acetaminophen ER and Celecoxib in people with Osteoarthritis, Knee, run by Bayer at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: Naproxen Sodium (Aleve, BAY117031), Acetaminophen ER and Celecoxib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 41 participants
Where: 5 sitesUnited States
Study dates: 29 Jun 2018to 14 Jun 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

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

Other trials in United States

About this study

Read the 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.

Conditions: Osteoarthritis, Knee
Being tested: Naproxen Sodium (Aleve, BAY117031), Acetaminophen ER, Celecoxib, Placebo
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Naproxen Sodium (Aleve, BAY117031)Drug
660 mg daily for 3 days, 440 mg on the fourth day, over-encapsulated tablet, oral (Treatment A)
Acetaminophen ERDrug
3900 mg daily for 3 days, 1300 mg on the fourth day, over-encapsulated extended release (ER) tablet, oral (Treatment B)
CelecoxibDrug
200 mg daily for 3 days, 100 mg on the fourth day, over-encapsulated capsule, oral (Treatment C)
PlaceboDrug
Over-encapsulation capsule, 4 days, oral (Treatment D)

Study groups in NCT03570554
Study group	Role	What they receive
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. Receives: Drug: Naproxen Sodium (Aleve, BAY117031); Drug: Acetaminophen ER; Drug: Celecoxib; Drug: Placebo
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. Receives: Drug: Naproxen Sodium (Aleve, BAY117031); Drug: Acetaminophen ER; Drug: Celecoxib; Drug: Placebo
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. Receives: Drug: Naproxen Sodium (Aleve, BAY117031); Drug: Acetaminophen ER; Drug: Celecoxib; Drug: Placebo
Treatment D-B-A-C	Experimental	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 Receives: Drug: Naproxen Sodium (Aleve, BAY117031); Drug: Acetaminophen ER; Drug: Celecoxib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 4 days

Secondary outcomes (2)

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.
Measured: 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.
Measured: Day 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jun 201814 Jun 2019

First posted27 Jun 2018
Study start29 Jun 2018
Primary completion14 Jun 2019
Study completion14 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03570554
Sponsor's protocol ID: 19783
Status last verified: Jun 2020
First submitted: 18 Jun 2018
Last updated: 19 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale
ClinicalTrials.gov ID: NCT03570554
Acronym / sponsor ID: 19783
Conditions: Osteoarthritis, Knee
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 29 Jun 2018 (actual)
Primary completion: 14 Jun 2019 (actual)
Study completion: 14 Jun 2019 (actual)
First posted: 27 Jun 2018 (actual)
Results: Posted 19 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Treatment A-D-C-B	Experimental	Drug: Naproxen Sodium (Aleve, BAY117031), Drug: Acetaminophen ER, Drug: Celecoxib, Drug: PlaceboParticipants 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	Drug: Naproxen Sodium (Aleve, BAY117031), Drug: Acetaminophen ER, Drug: Celecoxib, Drug: PlaceboParticipants 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	Drug: Naproxen Sodium (Aleve, BAY117031), Drug: Acetaminophen ER, Drug: Celecoxib, Drug: PlaceboParticipants 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	Drug: Naproxen Sodium (Aleve, BAY117031), Drug: Acetaminophen ER, Drug: Celecoxib, Drug: PlaceboParticipants 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

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Naproxen Sodium (Aleve, BAY117031)660 mg daily for 3 days, 440 mg on the fourth day, over-encapsulated tablet, oral (Treatment A)	Drug	Treatment A-D-C-B, Treatment B-C-D-A, Treatment C-A-B-D, Treatment D-B-A-C
Acetaminophen ER3900 mg daily for 3 days, 1300 mg on the fourth day, over-encapsulated extended release (ER) tablet, oral (Treatment B)	Drug	Treatment A-D-C-B, Treatment B-C-D-A, Treatment C-A-B-D, Treatment D-B-A-C
Celecoxib200 mg daily for 3 days, 100 mg on the fourth day, over-encapsulated capsule, oral (Treatment C)	Drug	Treatment A-D-C-B, Treatment B-C-D-A, Treatment C-A-B-D, Treatment D-B-A-C
PlaceboOver-encapsulation capsule, 4 days, oral (Treatment D)	Drug	Treatment A-D-C-B, Treatment B-C-D-A, Treatment C-A-B-D, Treatment D-B-A-C

Primary outcome

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.

2 secondary outcomes

Absolute Brief Arthritis Stiffness Scale (BASS) Score at Each Time Point
Time frame: 4 days
Change From Baseline in Brief Arthritis Stiffness Scale (BASS) Score at Day 4
Time frame: Day 4

Results and safety

Results posted to the registry on 19 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A-D-C-B	10	10
Treatment B-C-D-A	10	10
Treatment C-A-B-D	11	10
Treatment D-B-A-C	10	9

Primary outcome: Sum of Change in Brief Arthritis Stiffness Scale (BASS) Scores Over the 4-day Treatment Period

Time frame: 4 days. Least squares mean (Standard Error). Unit: Scores on a scale

Measure	Naproxen n = 37	Acetaminophen ER n = 37	Celecoxib n = 37	Placebo n = 36
Value	-12.6 (5.46)	-13.6 (5.46)	-11.7 (5.46)	-2.3 (5.47)

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: After the first dose of the investigational medicinal product (IMP) until the end of the treatment phase, up to 37 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Naproxen	0 of 39 (0%)	5 of 39 (12.8%)	0 of 39
Acetaminophen ER	0 of 40 (0%)	8 of 40 (20%)	0 of 40
Celecoxib	0 of 40 (0%)	10 of 40 (25%)	0 of 40
Placebo	0 of 39 (0%)	3 of 39 (7.7%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. 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.

Related trials for Osteoarthritis, Knee

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Naproxen Sodium (Aleve, BAY117031), Acetaminophen ER and Celecoxib in people with Osteoarthritis, Knee, run by Bayer at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sum of Change in Brief Arthritis Stiffness Scale (BASS) Scores Over the 4-day Treatment Period (time frame: 4 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03570554.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2020.