A Clinical Trial to Compare Safety and Effectiveness for Relieving Tenderness of 10% Naproxen Gel vs. a 2.32% Diclofenac Diethylamine Gel in the Treatment of Strains and Bruises of the Legs.

Summary

Researchers are looking for a different way to treat people who have an injury to their muscles, ligaments, or tendons in their legs or feet. This is known as a "soft tissue" injury. Before a treatment is available to all patients, researchers study it in trials to better understand its safety and how well it works.

People with soft tissue injuries can have pain, swelling, and bruising.

In this trial, the researchers want to learn more about the trial treatment, BAYH006689, in participants with a soft tissue injury to their legs or feet. BAYH006689 is a naproxen gel that is used for the temporary relief of minor aches and pains of muscles and joints. The researchers will learn more about how BAYH006689 works and how safe it is in these participants.

The trial will include about 100 male and female participants between the ages of 18 and 60. All the participants will have a soft tissue injury to their legs or feet that was caused by playing sports. The injury will have happened within 3 hours of joining the trial.

The researchers will use a computer program to randomly choose what treatment each participant will receive. This will help make sure the treatments are chosen fairly and that comparing the results of the treatments is as accurate as possible. The participants will be randomly chosen to be in 1 of 3 groups:

* Group 1: BAYH006689
* Group 2: diclofenac diethylamine gel
* Group 3: placebo

A placebo looks like a treatment but does not have any medicine in it. Diclofenac diethylamine gel is a treatment already available for doctors to be recommended to people with soft tissue injuries. The participants will receive their treatment once in the evening on Day 1 and then 2 times a day for 4 days. The participants will receive their final dose in the morning of Day 6. The doctors will apply the treatment to the participants' skin where the injury is.

The participants must be present at the clinic site 11 times over six days: once on Day 1 and twice daily on Days 2-6. During the trial, the doctors will:

* check the participants' overall health and ask if they have any medical problems
* do physical examinations to check the participants' injuries
* use a device to see how tender and sore the participants' injuries are

In this trial, the researchers will study how tender the participants' injuries are after 3 days and at other time points over the 6 day follow-up period. They will also study how many participants have medical problems during the trial.

Conditions

• Soft Tissue Injury

Interventions

DRUG

Naproxen gel

10%, bid for 5 days (final application on morning of Day 6)

DRUG

Diclofenac gel

2.32% bid for 5 days (final application on morning of Day 6)

DRUG

Placebo gel

bid for 5 days (final application on morning of Day 6)

Sponsors & Collaborators

• Deutsche Sporthochschule Köln

  collaborator OTHER

• Bayer

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-08

Primary Completion

2021-12-20

Completion

2021-12-20

FDA Drug

Yes

Countries

• Germany

Study Locations