Trials / Completed
CompletedNCT03556787
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 89 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Male
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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. 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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BPI 1000013 (Dr Scholls Insole) | Full length foam insole |
Timeline
- Start date
- 2018-06-04
- Primary completion
- 2018-11-08
- Completion
- 2018-11-08
- First posted
- 2018-06-14
- Last updated
- 2018-11-23
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03556787. Inclusion in this directory is not an endorsement.