Trial Condition(s):

Osteoarthritis, Knee

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

Bayer Identifier:

20244

ClinicalTrials.gov Identifier:

NCT03556787

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- 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.
Exclusion Criteria
- Subjects with knee pain which is due to a recent injury

Trial Summary

Enrollment Goal
89
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
BPI 1000013
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

The Wolf Group

Cincinnati, United States, 45242

Status
Completed
 
Locations

Focus & Testing, Inc.

Calabasas, United States, 91302

Status
Completed
 

Trial Design