Drug utilisation and incident rates of adverse events in children with sialorrhoea who are treated with glycopyrronium (Glyco Sialorrhoea)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49596
• EU PAS number:
  EUPAS48222
• Study ID:
  49596
• Official title and acronym:
  Drug utilisation and incident rates of adverse events in children with sialorrhoea who are treated with glycopyrronium (Glyco Sialorrhoea)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study will evaluate evidence of medical use of glycopyrronium for sialorrhoea in children with (a) specific focus on drug utilization, including underlying demographics, associated indications or underlying disease conditions, and (b) treatment emergent adverse events in patients started on glycopyrronium. This is a retrospective cohort study focusing on specific evidence on safety, with particular attention on the unknown frequency of cardiovascular events, urinary retention, and respiratory infections that may or may not be associated with glycopyrronium therapy
• Study status:
  Finalised

Research institutions and networks

Institutions

University of East Anglia

Study timelines

Date when funding contract was signed

Planned: 28/06/2022

Actual: 15/07/2022

Study start date

Planned: 29/07/2022

Actual: 09/08/2022

Data analysis start date

Planned: 30/08/2022

Date of final study report

Planned: 01/10/2022

Actual: 31/10/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Syri Ltd.

Regulatory

• Was the study required by a regulatory body?:
  Unknown
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable