DRKS00000361已完成1 期
Double-blind, block-randomised, placebo-controlled prospective trial with intraindividual comparison to assess the efficacy and safety of hyaluronidase (Hylase® Dessau) vs. placebo as adjuvant to local anaesthesia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 40 Years（—）
- 性别
- All
入选标准
- •1.male and female healthy volunteers, aged 18-40 years
- •2.Caucasian origin
- •3.written informed consent given by volunteer after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug
- •4.female subjects of childbearing potential willing to use contraception during the study period (i.e. abstinence, oral contraception, intrauterine device, diaphragm, condom, spermicide, implant contraception, systemic contraception) or have secondary infertility or whose partner had a vasectomy, or female subjects of non childbearing potential (i.e. had hysterectomy, bilateral ovariectomy, tubal ligation) or are post-menopausal defined as absence of menstrual bleeding for 1 year, or 6 month if laboratory confirmation of hormonal status
排除标准
- •1.atopic dermatitis or other skin diseases at the designated test areas (forearms)
- •2.known structure dysfunction of the skin with and without blister formation
- •3.incompatibility against local anaesthesia or any ingredient of the study medication
- •4.vegetarians and vegans
- •5.patch incompatibility
- •6.known deficiencies (i.e. iron, vitamin B12)
- •7.excessive hair growth on the forearms
- •8.concomitant procedures which would interfere with trial medication (as massaging injection area)
- •9.volunteers with collapse, shock, severe electrolyte disturbance or major dehydration
- •10.volunteers with increased risk of pulmonary congestion or oedema, severe congestive heart failure
- •11.known hypersensitivity to hyaluronidase or bovine proteins
- •12.congenital cardiac defect, venous congestion or shock symptoms
- •13.infections
- •14.volunteers with any type of cancer
- •15.General:
- •16.known contraindication for study medication
- •17.unreliability and/ or lack of cooperation, evidence of non-compliance
- •18.current or previous participation in another clinical trial within prior 12 weeks
- •19.pregnancy or lactation in female volunteers
- •20.signs of clinically relevant illness or mental illness up to four weeks prior to entry into the study
- •21.history of or current alcohol or drug abuse
- •22.other objections which avoid the participation in the study in the opinion of the investigator
- •23.legal incapacity and/or other circumstances rendering the volunteer able to understand the nature, scope and possible consequences of the study
研究者
相似试验
进行中（未招募）
1 期
Double-blind, randomised, placebo-controlled trial of nicotine replacement therapy in pregnancy - Smoking, Nicotine and Pregnancy (SNAP) TrialSmoking during pregnancy Specifically smoking 5 or more cigarettes currently (i.e. whilst pregnant) and having smoked 10 or more cigarettes prior to pregnancy.EUCTR2004-002621-46-GBniversity of Nottingham1,050
尚未招募
不适用
ESMAVAC - 1MalariaPACTR201712002879427Centre de Recherches Médicale de Lambaréné
已完成
不适用
Randomized, double-blind, placebo-controlled, three way crossover, double dummy, single centre study evaluating the effect of haloperidol 2 mg and lorazepam 1 mg on posturography and underlying systems involved in standing balance in 12 healthy elderly subjects.evenwichtsproblemenBalance disordersNL-OMON40805Centre for Human Drug Research12
进行中（未招募）
1 期
Clinical trial to investigate the effects of clonazepam on patients with ARID1B-related intellectual disability.ARID1B-related intellectual disabilityEUCTR2019-003558-98-NLCentre for Human Drug Research40
已完成
4 期
Randomized, double-blind, placebo-controlled, two way crossover, single centre study evaluating the acute and chronic effect of clonazepam on cognitive tests and patient-reported outcome measures in patients with ARID1B-related intellectual disabilityNL-OMON52899Centre for Human Drug Research40