Osteoarthritis, KneeNCT03556787
An Evaluation of a Gender Specific Insole to Provide Relief From Knee Pain Due to Osteoarthritis or General Anterior Knee Pain in Male Subjects When Used in Foot Wear Over a Period of Four Weeks
A study testing BPI 1000013 (Dr Scholls Insole) in people with Osteoarthritis, Knee, run by Bayer at 2 sites in United States.
Trial summary
The primary objective of this trial is to demonstrate the ability of a full length foam insole to provide relief from pain due to osteoarthritis of the knee or general knee pain when used in foot wear for a 4-week period of time. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- BPI 1000013 (Dr Scholls Insole)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Jun 2018to 8 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subjects with age 18 to 70 years and a self-reported foot size between 8 and 14
- Subjects with regular knee pain
- Subjects with a baseline pain level of pain of ≥20 mm to ≤90 mm on 100 mm VAS scale at baseline (Visit 1)
- Subjects must be able to walk unaided by cane or walker.
Who cannot join
- Subjects with knee pain which is due to a recent injury
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Focus & Testing, Inc.
Calabasas, California, 91302
The Wolf Group
Cincinnati, Ohio, 45242
About this study
The primary objective of this trial is to demonstrate the ability of a full length foam insole to provide relief from pain due to osteoarthritis of the knee or general knee pain when used in foot wear for a 4-week period of time.
The secondary objectives comprise the evaluation of the insole's ability to provide appropriate shoe fit and comfort as well as relief from osteoarthritis/ general knee pain after short-term use. The safety and tolerability of the test articles in terms of adverse events (AE) will also be investigated.
- Conditions
- Osteoarthritis, Knee
- Being tested
- BPI 1000013 (Dr Scholls Insole)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPI 1000013 (Dr Scholls Insole)Device
Full length foam insole
| Study group | Role | What they receive |
|---|---|---|
| Patients with knee pain | Experimental | Adults patients suffering from osteoarthritis pain or general knee pain Receives: Device: BPI 1000013 (Dr Scholls Insole) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteoarthritis knee pain according to Visual Analog Scale
100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible
Measured: Up to 4 weeks
General anterior knee pain according to Visual Analog Scale
100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible
Measured: Up to 4 weeks
Secondary outcomes (4)
Foot Comfort according to Likert scale
7-point Comfort/ Discomfort Likert scale, ranging from 1 = Extreme Discomfort to 7 = Extreme Comfort
Measured: Up to 4 weeks
Shoe Fit according to Likert scale
7-point Comfort/ Discomfort Likert scale, ranging from -3 = Much too loose fit to 3 = Much too tight fit
Measured: Up to 4 weeks
Number of subjects with adverse events
Measured: Up to 4 weeks
Number of subjects with serious adverse events
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start4 Jun 2018
- Primary completion8 Nov 2018
- Study completion8 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556787
- Sponsor's protocol ID
- 20244
- Status last verified
- Nov 2018
- First submitted
- 4 Jun 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Gender Specific Insole to Provide Relief From Knee Pain Due to Osteoarthritis or General Anterior Knee Pain in Male Subjects When Used in Foot Wear Over a Period of Four Weeks
- ClinicalTrials.gov ID
- NCT03556787
- Acronym / sponsor ID
- 20244
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 8 Nov 2018 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to demonstrate the ability of a full length foam insole to provide relief from pain due to osteoarthritis of the knee or general knee pain when used in foot wear for a 4-week period of time.
The secondary objectives comprise the evaluation of the insole's ability to provide appropriate shoe fit and comfort as well as relief from osteoarthritis/ general knee pain after short-term use. The safety and tolerability of the test articles in terms of adverse events (AE) will also be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with knee pain | Experimental | Device: BPI 1000013 (Dr Scholls Insole)Adults patients suffering from osteoarthritis pain or general knee pain |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male subjects with age 18 to 70 years and a self-reported foot size between 8 and 14
- Subjects with regular knee pain
- Subjects with a baseline pain level of pain of ≥20 mm to ≤90 mm on 100 mm VAS scale at baseline (Visit 1)
- Subjects must be able to walk unaided by cane or walker.
Key exclusion criteria (1 listed)
- Subjects with knee pain which is due to a recent injury
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 |
|---|---|---|
| BPI 1000013 (Dr Scholls Insole)Full length foam insole | Device | Patients with knee pain |
Primary outcome
Osteoarthritis knee pain according to Visual Analog Scale
Time frame: Up to 4 weeks
100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible
General anterior knee pain according to Visual Analog Scale
Time frame: Up to 4 weeks
100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible
4 secondary outcomes
Foot Comfort according to Likert scale
Time frame: Up to 4 weeks
Shoe Fit according to Likert scale
Time frame: Up to 4 weeks
Number of subjects with adverse events
Time frame: Up to 4 weeks
Number of subjects with serious adverse events
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BPI 1000013 (Dr Scholls Insole) in people with Osteoarthritis, Knee, run by Bayer at 2 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 4 inclusion and 1 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 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Osteoarthritis knee pain according to Visual Analog Scale (time frame: Up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2018.