Status: Finalised First registered on: 15/10/2018
Last updated on: 21/12/2018
1. Study identification
EU PAS Register NumberEUPAS26094
Official titleAn observational evaluation of the off-label prescribing and safety of glycopyrronium bromide for symptomatic treatment of severe sialorrhoea (drooling) and/or hyperhidrosis (excessive sweating)
Study title acronymGlycopyrronium Bromide
Study typeObservational study
Brief description of the studyThe 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.
Was this study requested by a regulator?Don't know
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsOPRI Pte Ltd
Department/Research groupObservational and Pragmatic Research Institute Pte Ltd
Organisation/affiliationOPRI Pte Ltd
Website/Homepagewww.opri.sg
Details of (Primary) lead investigator
Title Professor
Last name Price
First name David
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed20/08/201820/08/2018
Start date of data collection17/09/201817/09/2018
Start date of data analysis
Date of interim report, if expected
Date of final study report30/11/201829/10/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMorningside Healthcare100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 160 Paya Lebar Road,
Address line 2Paya Lebar Square 
Address line 3Singapore 
City409051 
PostcodeSingapore 
CountrySingapore
Phone number (incl. country code)4401223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@opri.sg
Public Enquiries
Title Professor 
Last name Price 
First name David 
Address line 15a Coles Lane 
Address line 2Oakington 
Address line 3 
CityCambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom 
Phone number (incl. country code)4401223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@opri.sg 
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