POP
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
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
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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