Comparison of Ivermectin alone with Albendazole (ALB) plus Ivermectin (IVM) in their efficacy against Onchocerciasis: a randomised open label trial

Case Western Reserve University (USA)0 个研究点目标入组 272 人开始时间: 2012年10月18日最近更新: 2021年1月5日

适应症

试验速览

•Current inclusion criteria as of 11/11/2013, as stated in the 2nd protocol amendment:
•1. Men and women 18-60 years residing in Ashanti and Central Regions of Ghana
•2. =1 accessible nodules
•3. Any Mf based on skin snips
•Previous inclusion criteria:
•1. Men and women 18-60 years residing in Central Region of Ghana
•2. =1 accessible nodules
•3. =5 Mf/mg based on skin snips

•Current exclusion criteria as of 11/11/2013, as stated in the 2nd protocol amendment:
•1. Last IVM treatment <7 months
•2. Pregnant (do pregnancy test) or breastfeeding
•3. Permanent disability, serious medical illnesses such as a stroke, advanced heart disease, uncontrolled diabetes, emphysema, etc. that prevents or impedes study participation and/or comprehension
•4. Weight of <40kg suggesting malnourishment
•5. AST/ALT, gamma-glutamyltranspeptidase (?-GT) > 1.5 upper limit of normal
•6. Significant glycosuria or proteinuria (2+ or 3+ protein or glucose)
•Previous exclusion criteria:
•1. Last IVM treatment <1 year
•2. Pregnant (do pregnancy test) or breastfeeding
•3. Permanent disability, serious medical illnesses such as a stroke, advanced heart disease, uncontrolled diabetes, emphysema, etc. that prevents or impedes study participation and/or comprehension
•4. Weight of <40kg suggesting malnourishment
•5. AST/ALT, gamma-glutamyltranspeptidase (?-GT) > 1.5 upper limit of normal
•6. Significant glycosuria or proteinuria (2+ or 3+ protein or glucose)

发起方

Case Western Reserve University (USA)