Study identification

PURI

https://redirect.ema.europa.eu/resource/40556

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

Ongoing
Research institution and networks

Institutions

Evidera
United Kingdom
First published:
07/03/2024
Institution
Laboratory/Research/Testing facilityNon-Pharmaceutical companyENCePP partner

Contact details

Javier Cid

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AbbVie
Study protocol
Initial protocol

P21-481-Protocol v13.1_abstract_Redacted (1)

English (430.95 KB - PDF)View document
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)