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NCT03556787 · ClinicalTrials.gov registry record · NA

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 NA study of Osteoarthritis, Knee, sponsored by Bayer.

Completed
Registry status
NA
Development phase
89
Enrollment target
2
Study locations

NCT03556787 is a NA study of Osteoarthritis, Knee that has completed, run by Bayer. The registered enrollment target is 89 participants, below the 579-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (85% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT03556787, a NA study of Osteoarthritis, Knee, has completed, sponsored by Bayer.

COMPLETED
Registry status
NA
Development phase
89 participants
Enrollment target
2
Study locations

Study 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 Studied

Osteoarthritis, Knee

Interventions

  • DEVICE BPI 1000013 (Dr Scholls Insole)

Study Locations (2)

California

  • Focus & Testing, Inc. - Calabasas

Ohio

  • The Wolf Group - Cincinnati

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2018-06-04
Est. Completion 2018-11-08
Phase NA

Sponsor

Bayer

591 total trials

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What the Registry Record Tells You About NCT03556787

The ClinicalTrials.gov registry entry for NCT03556787 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 579-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (85% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 1 intervention - of which BPI 1000013 (Dr Scholls Insole) is the first listed.

NCT03556787 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Ohio.

Frequently Asked Questions

What is clinical trial NCT03556787 about?

NCT03556787 is a clinical study titled "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". 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 abil...

What is the current status of trial NCT03556787?

This trial is currently completed. It is a NA study. The enrollment target is 89 participants. The study started on 2018-06-04. Estimated completion is 2018-11-08.

What conditions does trial NCT03556787 study?

This clinical trial studies the following conditions: Osteoarthritis, Knee.

What interventions are being tested in trial NCT03556787?

The interventions under investigation include: BPI 1000013 (Dr Scholls Insole) (DEVICE).

Who is sponsoring clinical trial NCT03556787?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03556787 being conducted?

This trial has 2 study locations across California, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.