A trial to learn how a naproxen gel affects the level of pain and soreness and how safe it is compared to both a diclofenac diethylamine gel and a placebo in participants who have an injury to muscles, ligaments, or tendons in their legs or feet
- Conditions
- acute strains, sprains or bruises of the lower extremities following blunt traumaTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2020-004343-92-DE
- Lead Sponsor
- Bayer Healthcare LLC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
1. Participant must be 18 to 60 years of age inclusive, at the time of signing the informed consent.
2. 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.
3. Participants with a baseline algometric measurement values on the injured site of =50% of the respective value at the contralateral site.
4. Participants with a baseline (POM) of =50 mm on a visual analog scale (VAS) (0–100 mm).
5. Participant’s absolute sensitivity to tenderness on the contralateral site is at least 2.5 N/cm² as measured by algometry.
6. Participant’s size of trauma is between 25 and 150 cm²
7. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Heart surgery within 2 weeks of enrollment in the study.
2. Suspected bone fracture or torn ligaments related to the injury.
3. Open wounds to the area to be treated.
4. Current skin disorders or localized infection in the area to be treated.
5. Injured area is too hairy for proper assessments.
6. Suspected head injury.
7. History of blood coagulation disorders.
8. Current or past history of gastrointestinal ulceration, gastrointestinal bleeding or
other bleeding disorder(s).
9. Relevant concomitant disease such as asthma (exercise induced asthma is
permitted).
10. 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.
11. 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.
12. Significant ongoing painful condition other than that associated with the sportrelated injury/contusion.
13. Any ongoing condition that might interfere with the absorption, distribution,
metabolism, or excretion of the study medication.
14. Females who are planning to become pregnant, are pregnant or lactating.
15. Ice and compression are prohibited from the time of injury through the final
evaluation.
16. Physical therapy or other comfort measures, or herbal preparations for bruises from the time of injury through the final evaluation.
17. 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).
18. 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.
19. 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.
20. 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.
21. 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.
22. Use of any over the counter (OTC) or prescription medications with which the administration of naproxen, acetaminophen, any other NSAID, is contraindicated.
23. 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).
24. More than low-risk alcohol consumption (>24 g
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method