An observational evaluation of the off-label prescribing and safety of glycopyrronium bromide for symptomatic treatment of severe sialorrhoea (drooling) and/or hyperhidrosis (excessive sweating) (Glycopyrronium Bromide)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27309
• EU PAS number:
  EUPAS26094
• Study ID:
  27309
• Official title and acronym:
  An observational evaluation of the off-label prescribing and safety of glycopyrronium bromide for symptomatic treatment of severe sialorrhoea (drooling) and/or hyperhidrosis (excessive sweating) (Glycopyrronium Bromide)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The proposed study will characterise real-world prescribing of GLY for the symptomatic treatment of severe sialorrhoea and/or excessive sweating. The study will then evaluate safety in patients prescribed GLY for sialorrhoea and/or excessive sweating compared to those not prescribed treatment. Data from this study will provide evidence towards a license evaluation for the use of GLY in the treatment of sialorrhoea and/or excessive sweating in adults in the UK.
• Study status:
  Finalised

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 20/08/2018

Actual: 20/08/2018

Study start date

Planned: 17/09/2018

Actual: 17/09/2018

Date of final study report

Planned: 30/11/2018

Actual: 29/10/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Morningside Healthcare

Regulatory

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