A Randomised Open Label Exploratory, Safety and Tolerability Study with PP100-01 in Patients Treated with the 12-hour Regimen of N-Acetylcysteine for Paracetamol/Acetaminophen Overdose Image To investigate how safe and well tolerated a new drug ‘PP100-01’ is when used together with the normal treatment for paracetamol overdose N-Acetylcysteine (NAC). Chief Investigator: Dr James Dear Number and location of participating sites (by region/ country): Single Centre - Royal infirmary Edinburgh EudraCT number: 2017-000246-21 Clinicaltrials.gov - NCT03177395 Funder: Pledpharma AB Start and End date of grant award: 04/01/2017-04/07/2018 Start and End date of recruitment: 08/06/2017-31/12/2017 Current status: Published https://www.ncbi.nlm.nih.gov/pubmed/31311721?dopt=Abstract UK GDPR Privacy Statement: If you have participated in this study and would like to read how it complies with UK GDPR, please read this document. Document ECTU POP GDPR privacy statement (93.41 KB / PDF) Sponsor: PledPharma AB, Grev Turegatan 11C, SE-114 46 Stockholm, Sweden Chief Investigator: Dr James Dear, University of Edinburgh, Queen’s Medical Research Institute, 47 Little France Crescent, Edinburgh EH16 4TJ, Scotland; Tel: +44 0131 242 9214; Email: james.dear@ed.ac.uk Trial Manager: Kat Oatey, Edinburgh Clinical Trials Unit, Usher Institute Level 2, Nine Edinburgh BioQuarter, 9 Little France Road, Edinburgh, EH16 4UX; Tel: +44 0131 651 9913, Email: k.oatey@ed.ac.uk Research Nurse: Bernadette Gallagher: Emergency Department, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh EH16 4SA Tel: 0131 242 2167; Email: Bernadette.Gallagher@nhslothian.scot.nhs.uk ECTU Involvement: Trial management / Statistics / Data base/ Data Management/ Monitoring This article was published on 2024-09-24
