Active surveillance of overdose with a prolonged-release formulation of tramadol/paracetamol. The PICS study.

Study identification

• EU PAS number:
  EUPAS39805
• Study ID:
  45995
• Official title and acronym:
  Active surveillance of overdose with a prolonged-release formulation of tramadol/paracetamol. The PICS study.
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  Hungary

  Poland

  Portugal

  Romania

  Slovakia

  Slovenia
• Study description:
  This is an observational, non-comparative, non-interventional and international, multicentre, prospective, single arm post-authorisation safety study carried out to monitor actively the safety of the product in terms of acute single intake overdose cases. Multiple clinical sites including Poison Information Centres and other designated clinical institutions will participate in countries where the product is on the market. Overdose cases will be followed during a single hospital stay of the subjects. Primary collection of data will be carried out during entire period of hospitalization. The follow up period is going to be approximately two years after the start of the study in the country with the latest start of the data collection.
• Study status:
  Ongoing

Research institutions and networks

Institutions

University Medical Centre Ljubljana

Department of Occupational Medicine First Faculty of Medicine, Charles University Toxicological Information Centre / 4th internal clinic, General University Hospital in Prague Prague, Czech Republic, Department of Emergency Medicine and Clinical Toxicology Budapest, Hungary, Hospital Curry Cabral – Unidade de Cuidados Intensivos Lisabon, Portugal, Childrens Hospital Grigore Alexandrescu Bucharest, Romania, II. Interna klinika SZU Dept Internal Med II.HEGITO div Hepatology, Gastroenterologty and Liver transplantation SZU slovak Medical University, FNsP F.D.Roosevelt Univ. Hospital Banska Bystrica, Slovakia, Pomeranian Center of Toxicology Gdansk, Poland

Study timelines

Date when funding contract was signed

Planned:31/03/2021

Actual:28/05/2021

Study start date

Planned:20/06/2021

Actual:15/07/2021

Data analysis start date

Planned:30/08/2023

Date of interim report, if expected

Planned:30/10/2023

Date of final study report

Planned:31/07/2025

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Krka, d. d. Novo mesto, Contractual partner, Tecnimede

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)