PRO/GLY/004 12 May 2017 V2.0
Research type
Research Study
Full title
Drug Utilization Study on the Risk Minimilisation Tools for Sialanar
IRAS ID
229639
Contact name
Katherine Martin
Contact email
Sponsor organisation
Proveca Ltd
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
The company sponsoring this project is Proveca Ltd, who are the Marketing Authorisation Holder of a drug called Sialanar. They have been asked by the regulatory authority to monitor and assess the effectiveness of the written documents that are provided with Sialanar.
Sialanar is a treatment for drooling; a condition where there is a loss of saliva from the mouth and it ranges quite widely from a mild form of drooling to quite severe where saliva spills onto clothes and the immediate environment. The research project will test the understanding of the information that is provided with Sialanar and that patient’s carers understand how Sialanar is used, how to change the dose and when to change the dose if the patient experiences side effects.
This research project is not requiring any changes to a child’s care; it is just collecting data for a one year period.The study data that is is being recorded is to assess whether the action that should be followed following any anticholinergic side effects (e.g. patient experienced constipation - temporary cessation of treatment or down titration) has been followed as per the information in the SPC, PIL, Educational Material for Physicians, Reminder Card for Carers. This is also appropriate for when patients are experiencing more drooling they can be up titrated but again if any anticholinergic side effects seen the appropriate action is taken based on information in the documents that accompany Sialanar.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
17/WM/0281
Date of REC Opinion
29 Aug 2017
REC opinion
Further Information Favourable Opinion