Linaclotide Utilisation Study in the UK - Extended Feasibility Counts

Date of Approval
Application Number
16_145
Technical Summary

IBS is a chronic, relapsing gastrointestinal condition characterised by abdominal pain, bloating and changes in bowel habits, categorised according to Rome III criteria based on the stool's characteristics into IBS-D, IBS-C and IBS-M. The prevalence of IBS varies depending on the diagnostic criteria used, ranging from 9.5% to 22.0% in the UK. Linaclotide is the first medicine authorised for the symptomatic treatment of moderate-to-severe IBS-C in adults in the EU. Use of linaclotide in certain population groups is not considered to be sufficiently documented in the linaclotide clinical development programme and the EMA has requested a drug utilisation study to be conducted in selected European countries, amongst them the UK. The aim of this study is to obtain counts of patients using linaclotide, especially in the population subgroups for which the use of linaclotide was not sufficiently documented in the clinical programme, which includes those under 18 years of age, the elderly, and patients with specific conditions. These will be used to inform on the feasibility of conducting a detailed post-authorisation safety study to describe the use of linaclotide in the UK.

Health Outcomes to be Measured

The primary outcome of this study is the number of patients receiving linaclotide, overall, by subgroup of interest.

Collaborators

Javier Cid - Chief Investigator - Evidera, Inc
Mireia Raluy Callado - Corresponding Applicant - Evidera, Inc
Selin Cooper - Collaborator - Evidera, Inc
Yan Bai - Collaborator - Allergan, Inc