Linaclotide Safety Study for the Assessment of Diarrhoea—Complications and Associated Risk Factors in Selected European Populations with IBS-C

20/09/2016
15/07/2025
EU PAS number:
EUPAS15353
Study
Finalised
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Study identification

EU PAS number

EUPAS15353

Study ID

40556

Official title and acronym

Linaclotide Safety Study for the Assessment of Diarrhoea—Complications and Associated Risk Factors in Selected European Populations with IBS-C

DARWIN EU® study

No

Study countries

Spain
Sweden
United Kingdom

Study description

This 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.

Study status

Finalised
Research institutions and networks

Institutions

PPD Evidera
Sweden
United Kingdom
United States
First published:
22/09/2025
Institution Laboratory/Research/Testing facility Non-Pharmaceutical company ENCePP partner

Contact details

Javier Cid

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AbbVie
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)