Soft Tissue InjuryPhase 2NCT05026320
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.
A Phase 2 study testing Naproxen gel and Diclofenac gel in people with Soft Tissue Injury, run by Bayer at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Soft Tissue Injury
- What is being tested?
- Naproxen gel and Diclofenac gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteGermany
- Study dates
- 8 Aug 2021to 20 Dec 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
- History of significant disease deemed by the investigator to render the patient unsuitable for inclusion, including evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hypertension and cardiac arrhythmia), hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years.
- 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.
- Use of any medications within 5 days of enrollment until discharge from the study site (except oral contraceptives, prophylactic antibiotics, synthetic thyroid hormones, methylphenidate or medications to treat benign conditions such as antibiotics to treat acne).
- Any other treatment or medication (oral or topical), that could interfere with the trial (e.g. corticosteroids) up to 3 days prior to the trial.
- Participants with the following medical conditions may be eligible at the discretion of the investigator: ADHD on a stable dose regimen of methylphenidate/(dextro) amphetamine for at least 6 months; participants with hypothyroidism on a stable dose of synthetic thyroid hormone for at least 6 months.
- Have received any form of treatment in the form of medication for depression in the past 6 months or any form of psychotropic agent (including selective serotonin uptake inhibitors [SSRI] but excluding ADHD medications described above) within the last 6 months.
- Any previous history of allergy or known intolerance to naproxen, diclofenac, paracetamol or any of the drugs or formulation constituents which, in the investigator's opinion, might preclude use of an NSAID, including aspirin-sensitive asthma or a previous allergic response to a NSAID, including bronchospasm, urticaria, angioedema, and rhinitis; participation in a clinical trial in the previous 30 days.
- Use of any over the counter (OTC) or prescription medications with which the administration of naproxen, acetaminophen, any other NSAID, is contraindicated.
- Habituation to analgesic drugs including opioids (i.e., routine use of oral analgesics 5 or more times per week for greater than 3 weeks within the past 2 years).
- Other Exclusions
- More than low-risk alcohol consumption (>24 g (males) or ˃12 g (females) of alcohol regularly per day). Amount corresponds to 0.6 L of beer/day or 0.24 L of wine/day or 3 glasses (at 2 cL) of liquor/day for males and 0.3 L of beer/day or 0.12 L of wine/day or 1 glass (at 2 cL) of liquor/day for females.
- Self-reported drug abuse within two years prior to screening.
- Member or first-degree relative of study staff or the Sponsor directly involved in the study.
- Unwilling or unable to comply with all requirements outlined in the protocol.
- Previous enrollment in this study.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Deutsche Sporthochschule Köln (DSHS)
Cologne, North Rhine-Westphalia, 50933
About this study
Official title: Randomized, Controlled, Double-blind, Placebo-controlled, Multi-center Hypothesis-finding Trial to Compare the Efficacy and Safety of a 10% Naproxen Gel vs. a 2.32% Diclofenac Diethylamine Gel and Placebo in the Treatment of Acute Soft Tissue Injuries of the Lower Extremities
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.
Read more
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
- Being tested
- Naproxen gel, Diclofenac gel, Placebo gel
- Medical subject headings
- Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen gelDrug
10%, bid for 5 days (final application on morning of Day 6)
Diclofenac gelDrug
2.32% bid for 5 days (final application on morning of Day 6)
Placebo gelDrug
bid for 5 days (final application on morning of Day 6)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to the initial 72 hours post dose
Secondary outcomes (2)
Percentage of Participants With at Least One Treatment Emergent Adverse Event After Treatment
An AE is any untoward medical occurrence in a clinical study participant, associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: 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
An AE is any untoward medical occurrence in a clinical study participant, associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: After first treatment on Day 1 until follow-up visit (Day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start8 Aug 2021
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Soft Tissue InjuryStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Deutsche Sporthochschule Köln
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026320
- Sponsor's protocol ID
- 21559
- Other IDs
- 2020-004343-92
- Status last verified
- Jan 2025
- First submitted
- 12 Jul 2021
- Last updated
- 22 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There are no current plans to share data. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Double-blind, Placebo-controlled, Multi-center Hypothesis-finding Trial to Compare the Efficacy and Safety of a 10% Naproxen Gel vs. a 2.32% Diclofenac Diethylamine Gel and Placebo in the Treatment of Acute Soft Tissue Injuries of the Lower Extremities
- ClinicalTrials.gov ID
- NCT05026320
- Acronym / sponsor ID
- 21559
- Conditions
- Soft Tissue Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Deutsche Sporthochschule Köln
- Study start
- 8 Aug 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Posted 22 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Naproxen Topical Gel (BAYH006689) | Experimental | Drug: Naproxen gelUI 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). |
| Diclofenac Diethylamine Gel | Active comparator | Drug: Diclofenac gelUI 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). |
| Placebo Gel | Placebo comparator | Drug: Placebo gelUI 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naproxen gel10%, bid for 5 days (final application on morning of Day 6) | Drug | Naproxen Topical Gel (BAYH006689) |
| Diclofenac gel2.32% bid for 5 days (final application on morning of Day 6) | Drug | Diclofenac Diethylamine Gel |
| Placebo gelbid for 5 days (final application on morning of Day 6) | Drug | Placebo Gel |
Primary outcome
Tenderness (Algometry) Over the Initial 72 Hours
Time frame: Up to the initial 72 hours post dose
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.
2 secondary outcomes
Percentage of Participants With at Least One Treatment Emergent Adverse Event After Treatment
Time frame: 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
Time frame: After first treatment on Day 1 until follow-up visit (Day 30)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There are no current plans to share data. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naproxen gel and Diclofenac gel in people with Soft Tissue Injury, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tenderness (Algometry) Over the Initial 72 Hours (time frame: Up to the initial 72 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025; AzTrials last refreshed its copy on 26 Oct 2026.