EUCTR2012-004980-39-GB进行中（未招募）1 期
A double blind randomised controlled trial on neuroprotection of amiloride in optic neuritis - Amiloride Clinical Trial in Optic Neuritis Version 1.0
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
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
入选标准
- •Patients with a first episode of unilateral ON • Participants with an existing diagnosis of relapsing remitting MS and new onset of ON are eligible if they have; Not had a previous episode of ON, A duration of disease of = 10 years An EDSS (Expanded Disability Status Scale) of =3. No immune modulating treatment other than ß-Interferon or Glatiramer Acetate at time of recruitment • Able to be randomised within 28 days of onset of visual symptoms • Visual acuity of =6/9 • Participant is willing and able to give informed consent for participation in the study and able to comply with study visits • Male or Female, aged between18 – 55 years. • Stable dose of current regular medication for at least 4 weeks prior to study entry. • Female participants of child bearing potential must be willing to use two effective methods of contraception (barrier methods, hormonal methods or abstinence) during the initial 5 month treatment period of the study and for one month thereafter. • Participant has clinically acceptable urea and electrolytes and estimated glomerular filtration rate (eGFR) >60 • Able and willing to comply with all study requirements. • Willing to allow his or her General Practitioner to be notified of participation in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 46
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Previous diagnosis of ON • Any concomitant immune suppressing or immune modulating therapy excluding ß-interferon or glatiramer acetate. • Female participants who are pregnant, lactating or planning pregnancy during the course of the study. • Concomitant potassium supplements, angiotensin converting enzyme inhibitors, angiotensin II antagonists, cyclosporine, tacrolimus or lithium • Any contra-indication to MRI – severe claustrophobia, metal implant, pacemaker, etc. • Participant who is terminally ill or is inappropriate for placebo medication • Impaired renal function : eGFR =60, anuria, acute or chronic renal insufficiency and evidence of diabetic nephropathy • Raised serum potassium (K+ >5.5mmol/l) • Diabetes • Significant concomitant eye disease in either eye that may affect diseased or fellow eye results. • Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study. • Participants who have participated in another research study involving an investigational product in the past 12 weeks.
研究者
相似试验
已完成
不适用
A double blinded randomised controlled study on the effect of laparoscopic excision on endometriosisEndometriosis / pelvic painSurgery - Surgical techniquesReproductive Health and Childbirth - Menstruation and menopauseACTRN12611000251921Dr Jason Abbott52
进行中（未招募）
1 期
A double blinded randomised controlled trial of injection of botulinum toxin versus normal saline into the puborectalis muscle in patients with pelvic floor dyssynergia.Obstructed defeacationEUCTR2005-001378-29-GBBradford Teaching Hospitals NHS Foundation Trust20
已完成
不适用
Antibiotic prophylaxis in varicose vein surgerySurgery: Varicose veinSurgeryVaricose veinISRCTN12467340Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)572
已完成
不适用
Calcium supplementation and weight-bearing physical activity: do they have a combined effect on the bone mineral density of pre-pubertal children?Calcium supplementation and bone mineral densityNutritional, Metabolic, EndocrineCalcium supplementationISRCTN84437785Action Medical Research (UK)86
尚未招募
4 期
Study for assessing technique for pain relief in children undergoing cleft lip surgery.CTRI/2023/03/050425SRM