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.

NCT05026320 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 215592020-004343-92
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Tenderness (Algometry) Over the Initial 72 Hours

  Algometry area under the curve (AUC) from zero to the initial 72h post dose. The 72h AUC algometry data was an aggregate of all measurements from timepoints and data including the 72h timepoint. The average data of all participants was reported.

  Up to the initial 72 hours post dose

Secondary Outcomes (2)

• Percentage of Participants With at Least One Treatment Emergent Adverse Event After Treatment

  After first treatment on Day 1 until follow-up visit (Day 30)

• Number of Participants With at Least One Treatment Emergent Adverse Event After Treatment

  After first treatment on Day 1 until follow-up visit (Day 30)

Study Arms (3)

Naproxen Topical Gel (BAYH006689)

EXPERIMENTAL

UI Number: 1614000-268; Subjects will be randomized into one of the three treatment groups in a 2:2:1 (active:active:placebo) allocation. Treatment consists of a twice daily (bid) application (approximately 12 hours apart) of the assigned topical gel over 5 consecutive days, beginning on the evening of Day 1 and ending (last application) on the morning of Day 6 (total of 10 applications). In order to assure adequate representation of different types of soft tissue injuries, at least 25 randomized subjects must enter the study with a lower extremity sprain/strain injury (cohort) and at least 50 randomized subjects with a lower extremity contusion injury (cohort).

Drug: Naproxen gel

Diclofenac Diethylamine Gel

ACTIVE COMPARATOR

UI Number: Not applicable; Subjects will be randomized into one of the three treatment groups in a 2:2:1 (active:active:placebo) allocation. Treatment consists of a twice daily (bid) application (approximately 12 hours apart) of the assigned topical gel over 5 consecutive days, beginning on the evening of Day 1 and ending (last application) on the morning of Day 6 (total of 10 applications). In order to assure adequate representation of different types of soft tissue injuries, at least 25 randomized subjects must enter the study with a lower extremity sprain/strain injury (cohort) and at least 50 randomized subjects with a lower extremity contusion injury (cohort).

Drug: Diclofenac gel

Placebo Gel

PLACEBO COMPARATOR

UI Number: 1614000-272; Subjects will be randomized into one of the three treatment groups in a 2:2:1 (active:active:placebo) allocation. Treatment consists of a twice daily (bid) application (approximately 12 hours apart) of the assigned topical gel over 5 consecutive days, beginning on the evening of Day 1 and ending (last application) on the morning of Day 6 (total of 10 applications). In order to assure adequate representation of different types of soft tissue injuries, at least 25 randomized subjects must enter the study with a lower extremity sprain/strain injury (cohort) and at least 50 randomized subjects with a lower extremity contusion injury (cohort).

Drug: Placebo gel

Interventions

Naproxen gel DRUG

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

Naproxen Topical Gel (BAYH006689)

Diclofenac gel DRUG

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

Diclofenac Diethylamine Gel

Placebo gel DRUG

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

Placebo Gel

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participant must be 18 to 60 years of age inclusive, at the time of signing the informed consent.
• Participants with a primary diagnosis of acute sports-related acute soft tissue injuries of the lower extremities that do not require hospitalization and that occurred within 3 hours of enrollment.
• Participants with a baseline algometric measurement values on the injured site of ≤50% of the respective value at the contralateral site.
• Participants with a baseline pain on movement (POM) of ≥50 mm on a visual analog scale (VAS) (0-100 mm).
• Participant's absolute sensitivity to tenderness on the contralateral site is at least 2.5 N/cm2 as measured by algometry.
• Participant's size of trauma is between 25 and 150 cm\^2.

You may not qualify if:

• Heart surgery within 2 weeks of enrollment in the study.
• Suspected bone fracture or torn ligaments related to the injury.
• Open wounds to the area to be treated.
• Current skin disorders or localized infection in the area to be treated.
• Injured area is too hairy for proper assessments.
• Suspected head injury.
• History of blood coagulation disorders.
• Current or past history of gastrointestinal ulceration, gastrointestinal bleeding or other bleeding disorder(s).
• Relevant concomitant disease such as asthma (exercise induced asthma is permitted).
• Participants with a medical disorder, condition, or history of such that could impair the participant's ability to participate or complete this trial in the opinion of the investigator.
• Significant ongoing painful condition other than that associated with the sports-related injury/contusion.
• Any ongoing condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.
• Females who are planning to become pregnant, are pregnant or lactating. Prior/Concomitant Therapy
• Ice and compression are prohibited from the time of injury through the final evaluation.
• Physical therapy or other comfort measures, or herbal preparations for bruises from the time of injury through the final evaluation.

Sponsors & Collaborators

• Bayer: lead
• Deutsche Sporthochschule Köln: collaborator

Study Sites (1)

Deutsche Sporthochschule Köln (DSHS)

Cologne, North Rhine-Westphalia, 50933, Germany

Location

Related Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

MeSH Terms

Conditions

Soft Tissue Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

(+) 1-888-8422937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 30, 2021
• Study Start: August 8, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: January 22, 2025
• Results First Posted: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)