Status: Finalised First registered on: 17/03/2016
Last updated on: 11/03/2020
1. Study identification
EU PAS Register NumberEUPAS12839
Official titleLinaclotide Utilisation Study in Selected European Populations
Study title acronym
Study typeObservational study
Brief description of the studyThis study plans to describe the characteristics of patients newly prescribed linaclotide, especially in certain population subgroups for which the use of linaclotide was not sufficiently documented in the clinical programme (including the elderly, males, pregnant or breast-feeding women, and patients with specific comorbidities or taking other medications), and in groups with potential off-label use and patients with potential for abuse/excessive use. Linaclotide treatment patterns will be also described.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableEVM-13108 CMO-EPI-GI-0567
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsEvidera
Department/Research groupReal World Evidence
Organisation/affiliationEvidera
Website/Homepagewww.evidera.com
Details of (Primary) lead investigator
Title Dr
Last name Cid
First name Javier
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2

IDIAPJGol
Countries in which this study is being conducted
International study

Spain
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed27/03/2015
Start date of data collection13/05/2013
Start date of data analysis08/05/201701/08/2018
Date of interim report, if expected
Date of final study report31/12/201830/09/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAllergan100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Cid
First name Javier
Address line 1Metro Building 6th Floor
Address line 21 Butterwick 
Address line 3 
CityLondon 
PostcodeW6 8DL 
CountryUnited Kingdom
Phone number (incl. country code)34932213441 
Alternative phone number4407769275683 
Fax number (incl. country code) 
Email address javier.cid@evidera.com
Public Enquiries
Title Dr 
Last name Cid 
First name Javier 
Address line 1Metro Building 6th Floor 
Address line 21 Butterwick 
Address line 3 
CityLondon 
PostcodeW6 8DL 
CountryUnited Kingdom 
Phone number (incl. country code)34932213441 
Alternative phone number4407769275683 
Fax number (incl. country code) 
Email address javier.cid@evidera.com 
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