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.
Condition: Soft Tissue Injury
MeSH terms: Soft Tissue Injuries
Study type: Interventional
Phase: Phase 2

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: 4 grams (g) of BAYH006689

        -  Group 2: 4 g of a diclofenac diethylamine gel

        -  Group 3: 4 g of a 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.
    


Intervention name(s): Naproxen gel; Diclofenac gel; Placebo gel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10%, bid for 5 days (final application on morning of Day 6); 2.32% bid for 5 days (final application on morning of Day 6); bid for 5 days (final application on morning of Day 6)
Intervention MeSH terms: Diclofenac; Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research