Back to resultsAn 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
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BPI 1000013 (Dr Scholls Insole)
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
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
Sites / Locations
- Focus & Testing, Inc.
- The Wolf Group
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with knee pain
Arm Description
Adults patients suffering from osteoarthritis pain or general knee pain
Outcomes
Primary Outcome Measures
Osteoarthritis knee pain according to Visual Analog Scale
100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible
General anterior knee pain according to Visual Analog Scale
100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible
Secondary Outcome Measures
Foot Comfort according to Likert scale
7-point Comfort/ Discomfort Likert scale, ranging from 1 = Extreme Discomfort to 7 = Extreme Comfort
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
Number of subjects with adverse events
Number of subjects with serious adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03556787
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
November 8, 2018 (Actual)
Study Completion Date
November 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with knee pain
Arm Type
Experimental
Arm Description
Adults patients suffering from osteoarthritis pain or general knee pain
Intervention Type
Device
Intervention Name(s)
BPI 1000013 (Dr Scholls Insole)
Intervention Description
Full length foam insole
Primary Outcome Measure Information:
Title
Osteoarthritis knee pain according to Visual Analog Scale
Description
100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible
Time Frame
Up to 4 weeks
Title
General anterior knee pain according to Visual Analog Scale
Description
100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
Foot Comfort according to Likert scale
Description
7-point Comfort/ Discomfort Likert scale, ranging from 1 = Extreme Discomfort to 7 = Extreme Comfort
Time Frame
Up to 4 weeks
Title
Shoe Fit according to Likert scale
Description
7-point Comfort/ Discomfort Likert scale, ranging from -3 = Much too loose fit to 3 = Much too tight fit
Time Frame
Up to 4 weeks
Title
Number of subjects with adverse events
Time Frame
Up to 4 weeks
Title
Number of subjects with serious adverse events
Time Frame
Up to 4 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Focus & Testing, Inc.
City
Calabasas
State/Province
California
ZIP/Postal Code
91302
Country
United States
Facility Name
The Wolf Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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