acute strains, sprains or bruises of the lower extremities following blunt trauma
Conditions
Interventions
Product Name: Naproxen Gel
Pharmaceutical Form: Gel
INN or Proposed INN: Naproxen Gel 0,1g/g
Other descriptive name: NAPROXEN
Concentration unit: g gram(s)
Concentration type: equal
Concentration numb
Sponsors
Bayer Healthcare LLC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effectivenss of a naproxen gel 10%,diclofenac diethylamine gel 2.32% and placebo for relieving tenderness to pressure in subjects with acute soft tissue injuries of the lower extremities. ;Secondary Objective: 1. To assess the safety of a naproxen gel 10%,diclofenac diethylamine gel 2.32% and placebo during a 5 day treatment period. 2. To assess adverse events.;Primary end point(s): Tenderness (Algometry) over the initial 72 hours (Algometry AUC 0-72);Timepoint(s) of evaluation of this end point: Tenderness over 72h from start of study medication | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety (percentage of subjects with at least one treatment emergent adverse event); Incidence of adverse events.;Timepoint(s) of evaluation of this end point: from study start treatment to study end treatment (0h-120h) | — |
Countries
Germany
Contacts
Public ContactBruno Gianetti
Clinsearch GmbH
Outcome results
None listed