EUCTR2007-004155-11-GB进行中（未招募）不适用
A double blind, placebo controlled trial to investigate the efficacy and safety of two concentrations of Juvidex in accelerating the healing of split thickness skin graft donor sites using different dosing regimes - Juvidex - SGDS
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Renovo Ltd
- 入组人数
- 195
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. Subjects aged 18-85 years who have given written informed consent
- •2. A body mass index between 18-35 calculated using Quetelets index
- •3. Subjects with, in the opinion of the investigator, clinically acceptable results for the laboratory tests and ECG as specified in the trial protocol. All laboratory tests must be performed within 28 days of the first trial dose administration
- •4. Female patients of child bearing potential who are using a highly effective method(s) of contraception and agree to do so from at least screening visit until 1 month after administration of the final study dose. For the purposes of the protocol, highly effective method(s) of contraception will be defined as consistently and correctly used implants, injectables, combined oral contraceptives, sexual abstinence or a vasectomised partner.
- •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. Subjects who on direct questioning and physical examination have history or evidence of hypertrophic or keloid scarring
- •2. Subjects with tattoos, birthmarks, moles or previous scars within 3cm of the area to be investigated during the trial
- •3. Afro-carribean subjects because of their increased susceptibility to hypertrophic and keloid scarring
- •4. Subjects who have had surgery in the area to be investigated within 1 year of the first dosing day
- •5. Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in the trial
- •6.Subjects with any clinically significant medical condition or history of any condition that would impair wound healing, including:
- •(a) subjects with renal impairment (CLcr < 80/ml/min)
- •(b) significant hepatic impairment (LFTs>3 times upper limit of normal)
- •(c) Congestive heart failure with a classification of >2 (NYHA classification)
- •(d) History of myocardial infarction, ischaemic heart disease (or presenting with symptoms or signs compatibile with ischaemic heart disease), coronary vasospasm or peripheral vascular disease
- •(e) Subjects with significant cerebrovascular disease including a history of stroke, transient ischaemic attacks or haemorrhage
- •(f) Malignancy (unless treated and disease-free for 5 years)
- •(g) Autoimmune disease (including active rheumatoid arthritis), immunosupression (oral corticosteroids) or chemotherapy within the last 12 months
- •(h) uncontrolled hypertension SBP>180mmHg, DBP>95mmHG
- •(i) Diabetes (except diet controlled)
- •(j) significant respiratory disease
- •(7) subjects with a history of clinically relevant allergy, hypersensitivity, angioedema or anaphylaxis
- •(8) Subjects with a progressive neurological condition including Parkinson's disease, Alzheimer's disease and uncontrolled epilepsy
- •(9) Subjects with a history of chronic viral infection (Hepatitis, HIV) or ongoing active infection
- •(10) Subjects with bleeding disorders including haemophilia, purpura or thrombocytopenia or receiving anticoagulants (e.g. warfarin, coumadin)
- •(11) Subjects who have taken any investigational product in the 12 months prior to first trial dose administration
- •(12) Subjects undergoing investigations or changes in management for an exisiting medical condition
- •(13) Subjects with a history of substance abuse or dedpendency (history of recreational use of cannabis is acceptable assuming a negative urine test for cannabis at screen). Subjects who have had a history of alcohol abuse but have been dependency free for 12 months will still be eligible.
- •(14) Subjects with any condition or serious illness which in the opinion of the investigator would intefere with study participation
- •(15) Subjects with ongoing psychiatric condition requiring treatment or psychosis
- •(16) Female subjects who are breast feeding or intending to become pregnanct or breast feed during the study
- •(17) Femal subjects who have had any change in their oral contraceptive medication in the 2 months prior to day 0, or anticipate any change during study participation
研究者
相似试验
进行中（未招募）
1 期
A double blind, placebo controlled study to investigate the role of NMDA receptor NR2B subunit selective antagonism on cognitive functions and neurophysiology in healthy subjects as measured with MRI - The effects of a novel NMDA NR2B-subtype selective antagonist, EVT 101, on brain functioEUCTR2007-000986-40-GBEvotec NeurosciencesGmbH20
进行中（未招募）
1 期
A Double Blind, Placebo Controlled Trial to Investigate the Efficacy of Zesteem in Accelerating the Healing of Split Thickness Skin Graft Donor Sites - Zesteem in accelerating the healing of split thickness skin graft donor sites.Wound HealingMedDRA version: 8.1 Level: LLT Classification code 10036892 Term: Promotion of wound healingEUCTR2006-005049-12-GBRenovo Ltd296
进行中（未招募）
不适用
A Double Blind, Placebo Controlled Trial to Investigate the Efficacy of Zesteem in Accelerating the Healing of Split Thickness Skin Graft Donor Sites - Zesteem in accelerating the healing of split thickness skin graft donor sites.Wound HealingMedDRA version: 8.1Level: LLTClassification code 10036892Term: Promotion of wound healingEUCTR2006-005049-12-LVRenovo Ltd296
进行中（未招募）
不适用
A Double Blind, Placebo Controlled Trial to Investigate the Efficacy of Zesteem in Accelerating the Healing of Split Thickness Skin Graft Donor Sites - Zesteem in accelerating the healing of split thickness skin graft donor sites.Wound HealingMedDRA version: 8.1Level: LLTClassification code 10036892Term: Promotion of wound healingEUCTR2006-005049-12-DERenovo Ltd296
进行中（未招募）
1 期
A clinical trial investigating the effect of the anti-depressant fluoxetine on learning and memory in people with epilepsy.Mesial Temporal Lobe EpilepsyMedDRA version: 18.0 Level: PT Classification code 10043209 Term: Temporal lobe epilepsy System Organ Class: 10029205 - Nervous system disordersEUCTR2014-005088-34-GBCardiff University60