Study identification

EU PAS number

EUPAS12839

Study ID

34073

Official title and acronym

Linaclotide Utilisation Study in Selected European Populations

DARWIN EU® study

No

Study countries

Spain
Sweden
United Kingdom

Study description

This 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.

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

Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

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

More details on funding

Allergan
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)