EUCTR2020-004343-92-DE进行中（未招募）1 期
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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
- •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
- •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
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