Status: Ongoing First registered on: 19/09/2016
Last updated on: 08/12/2020
1. Study identification
EU PAS Register NumberEUPAS15353
Official titleLinaclotide Safety Study for the Assessment of Diarrhoea—Complications and Associated Risk Factors in Selected European Populations with IBS-C
Study title acronym
Study typeObservational study
Brief description of the studyThis study is planned to assess the safety of linaclotide in terms of the risk of severe complications of diarrhoea (SCD) during treatment and other risk factors among patients with Irritable bowel syndrome (IBS) predominantly with constipation (IBS-C). Linaclotide is the first medicine authorised for the symptomatic treatment of IBS in the European Union.
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-18888 CMO-EPI-GI-0566
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 signed25/08/2016
Start date of data collection13/05/201313/05/2013
Start date of data analysis16/04/2018
Date of interim report, if expected
Date of final study report30/06/2021
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 2 
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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