A multicentre, non-interventional, prospective observational study of the use of the sufentanil sublingual tablet system (Zalviso®) for the management of acute postoperative pain in a hospital setting (ZAS)

Study identification

• EU PAS number:
  EUPAS16829
• Study ID:
  29857
• Official title and acronym:
  A multicentre, non-interventional, prospective observational study of the use of the sufentanil sublingual tablet system (Zalviso®) for the management of acute postoperative pain in a hospital setting (ZAS)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  This postmarketing surveillance study pursues two aims. Firstly, the demographic and surgical characteristics of patient-controlled analgesia with Zalviso® will be studied in French patients with acute postoperative pain. Secondly, the efficacy, safety, tolerability and quality of life data will be reviewed under routine conditions of everyday clinical practice. The study will be conducted in the routine medical setting.
• Study status:
  Finalised

Research institutions and networks

Institutions

Grünenthal GmbH

Multiple centres: 11 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:30/09/2016

Actual:03/04/2017

Study start date

Planned:30/09/2016

Actual:10/04/2017

Data analysis start date

Planned:22/12/2017

Actual:08/08/2018

Date of final study report

Planned:28/09/2018

Actual:20/12/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Grünenthal GmbH

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable