Linaclotide Utilisation Study in Selected European Populations

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/34073
• 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 institution and networks

Institutions

Evidera

United Kingdom

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

Contact details

Javier Cid

Study contact

[e-mail]

Javier Cid

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual: 27/03/2015

Data collection

Actual: 13/05/2013

Start date of data analysis

Planned: 08/05/2017

Actual: 01/08/2018

Date of final study report

Planned: 31/12/2018

Actual: 30/09/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Allergan

Study protocol

Initial protocol

Linaclotide_DUS_protocol_v4.2_26Jan17_Final_Redacted

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)

Other study registration identification numbers and links

EVM-13108CMO-EPI-GI-0567