Incidence and pattern description of gastrointestinal, skin, genital, corneal, and mucosal erosions, ulcerations, perforations, haemorrhages, fistulas, abscesses, delayed wound healing and death among patients treated with nicorandil with and without diverticular disease

Study identification

• EU PAS number:
  EUPAS13205
• Study ID:
  23413
• Official title and acronym:
  Incidence and pattern description of gastrointestinal, skin, genital, corneal, and mucosal erosions, ulcerations, perforations, haemorrhages, fistulas, abscesses, delayed wound healing and death among patients treated with nicorandil with and without diverticular disease
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study is to quantify the time-related risk (i.e., the incidence) and patterns of erosions, ulcerations, perforations, haemorrhages, abscesses, fistulae, delayed wound healing in patients treated with nicorandil (including but not restricted to gastrointestinal, skin, ocular, mucosal, anal, alone or in multiple locations), and death in a real world setting, together with the exploration of high risk subgroups (including patients with diverticular disease), other risk factors, and a dose & time effect assessment.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck Healthcare KGaA

Germany

Study timelines

Date when funding contract was signed

Planned: 01/12/2015

Actual: 02/12/2015

Study start date

Planned: 01/05/2016

Actual: 15/08/2016

Date of final study report

Planned: 01/12/2016

Actual: 20/03/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck KGaA, - Chugai Pharmaceutical Co. Ltd and Sanofi-Aventis

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)