Non-interventional study to investigate patterns of use of Selincro®
Research type
Research Study
Full title
Non-interventional multi-country prospective cohort study to investigate patterns of use of Selincro® and frequency of adverse drug reactions in routine clinical practice
IRAS ID
157450
Contact name
Jonathan D. Chick
Contact email
Sponsor organisation
Lundbeck SAS
Clinicaltrials.gov Identifier
ENCEPP/SDPP/5678, EU PAS register number
Duration of Study in the UK
2 years, 9 months, 1 days
Research summary
Selincro® has received a positive opinion from the European Commission. A Post-Authorisation Safety Study (PASS) has been proposed to investigate patterns of use of Selincro® and frequency of Adverse Drug Reactions (ADRs) of special interest in patients treated with Selincro® in routine clinical practice. The PASS will take into account the important risks and missing information documented in the Risk Management Plan (RMP) in order to inform and potentially refine pharmacovigilance planning and risk management for Selincro® and to assess the compliance to the Summary of Product Characteristics (SmPC).
The main objectives are consequently to describe:
- the patterns of use of Selincro® in routine clinical practice, taking into account the important risks and missing information documented in the Selincro® RMP,
- the frequency of Adverse Drug Reactions of special interest in patients treated with Selincro® in routine clinical practice in the entire study population and in the subpopulations of interest.The study will enrol 2000 patients in approximately 10 countries. These patients are those diagnosed with alcohol dependence who have a high drinking risk level, without physical withdrawal symptoms and who do not require immediate detoxification.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
14/YH/1186
Date of REC Opinion
11 Dec 2014
REC opinion
Further Information Favourable Opinion