Glycopyrronium Bromide 1mg/5ml Oral Solution Research Study
Research type
Research Study
Full title
A study to assess utilisation and safety of Glycopyrronium Bromide 1mg/5ml Oral Solution as licensed for symptomatic treatment of severe sialorrhoea in children and adolescents aged 3 years and older with chronic neurological disorders in the UK
IRAS ID
292301
Contact name
Sandeep Dhanda
Contact email
Sponsor organisation
Drug Safety Research Unit
Clinicaltrials.gov Identifier
20/WA/0235 Wales REC 4 , ; , ; ,
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
The aim of this study is to assess the utilisation and safety of Glycopyrronium Bromide Oral Solution 1mg/5ml for symptomatic treatment of severe sialorrhoea (drooling) in children and adolescents aged 3 years and older with chronic neurological disorders in the UK.
Paediatric centres/prescribers will be invited to participate in the study, recruited through relevant National Institute for Health Research (NIHR) networks. Paediatric patients (<18 years) resident in the UK who have been prescribed Glycopyrronium Bromide 1mg/5ml Oral Solution (or Glycopyrronium Bromide where the concentration has not been specified) as advised/prescribed by recruited paediatricians will be eligible to take part and invited to participate in the study. Prescribers will be asked to abstract information from patients’ medical notes, that has been recorded as part of routine clinical practice, onto electronic data collection forms over a 12-month observation period. This will be pseudonymised and will contain information about the patient at the time the medication was first prescribed, as well as treatment details and safety outcome information relating to the treatment period. The patient’s General Practitioner (GP) providing follow up care will also be approached for information.
The study aims to recruit a minimum of 100 patients who have been prescribed Glycopyrronium Bromide 1mg/5ml Oral Solution.
REC name
Wales REC 4
REC reference
20/WA/0337
Date of REC Opinion
10 Dec 2020
REC opinion
Unfavourable Opinion