EUCTR2004-004670-88-DK进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of ALGRX 4975 in Subjects after Inguinal Hernia Repair - Acute Hernia Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- Male
入选标准
- •1.The subject is male and aged 18 - 70 years.
- •2.The subject has a primary hernia and will undergo hernia repair by standard Lichtenstein mesh repair.
- •3.The subject is willing and able to understand the study procedures and the use of pain scales, and to communicate meaningfully with the study personnel.
- •4.The subject is in good health, with no unstable or uncontrolled medical conditions, as determined by the investigator on the basis of medical history, physical examination, and screening laboratory results.
- •5.The subject has signed the Informed Consent approved by the IRB/Ethics Committee.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.The subject has undergone a lower abdomen surgical procedure in the past.
- •2.The use of capsaicin, bupivacaine, tramadol, ibuprofen, or paracetamol is contraindicated in this subject (e.g., significant history of allergic reactions or intolerance to these or related substances).
- •3.The subject has a presence of any medical condition or instability that in the Investigator’s opinion could adversely impact their participation in the study or the collection of data, including chronic conditions that are likely to alter the rate of healing or are likely to result in safety complications unrelated to the study drug, such as uncontrolled diabetes mellitus (HbA1c > 9%).
- •4.The subject has a systolic blood pressure greater than 150 or diastolic blood pressure greater than 95 mm Hg, respectively.
- •5.The subject has personal or familial contraindications in undergoing general anesthesia.
- •6.The subject is taking digoxin, antiarrhythmics except beta blockers, warfarin, theophylline preparations, aminoglycosides, anticonvulsants except benzodiazepines, or lithium.
- •7.The subject has a medical condition, other than the one being studied that requires the use of a pain medication or CNS active drugs for pain such as tricyclic antidepressants. The use of low dose aspirin for cardiovascular prophylaxis is permitted.
- •8.The subject is currently scheduled to undergo bilateral inguinal hernia repair.
- •9.The subject has a history of drug or alcohol abuse within the past 2 years.
- •10.The subject is taking an antihypertensive agent that has not been at a stable dose for at least 4 weeks, or an antidepressant or psychotropic that has not been stable for at least 2 months. The subject is using an antidepressant as an analgesic.
- •11.The subject has taken an investigational medication within 3 months prior to the administration of study drug (Visit 2), or is scheduled to receive an investigational drug other than ALGRX 4975 while participating in the study.
- •12.The subject has previously participated in a clinical study with ALGRX 4975.
研究者
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