ZEUS - Zalviso in the EU after Surgery
Research type
Research Study
Full title
A multicentre, non-interventional, prospective observational study of the use of the sufentanil self-managed delivery system (Zalviso®) for the management of acute post-operative pain in a hospital setting
IRAS ID
226304
Contact name
Garth Baxter
Contact email
Sponsor organisation
Grünenthal Ltd
Clinicaltrials.gov Identifier
U1111-1177-7356, WHO Universal Trial Number (UTN); EUPAS18378, EU PAS Register
Duration of Study in the UK
0 years, 9 months, 26 days
Research summary
Zalviso is a handheld pre-programmed, non-invasive drug device system, to deliver a single sufentanil 15 micrograms sublingual tablet, on a patient-controlled as needed basis, with a minimum of 20 minutes (lockout interval) between doses, over a period of up to 72 hours.\nThough recently approved for use in the EU, evidence of efficacy and safety for the use of Zalviso is derived from randomised controlled trials conducted in the US. The aim of this multicentre, non-interventional, prospective, observational study is to assess the effectiveness of Zalviso in adult patients with acute moderate-severe post-operative pain treated in UK clinical practice in a hospital setting.\nConsenting adult patients (18 years and older) prescribed Zalviso for the management of acute moderate to severe post-operative pain in accordance with the Zalviso Summary of Product Characteristics are eligible for inclusion in the study.\nIn the UK (and Ireland) three hundred patients will be included in this observational study. Approximately 10 hospitals with appropriate surgical departments will be selected to participate in the study. Thirty patients will be included and documented per site, with eligible, consenting patients being enrolled consecutively.\nThe primary endpoint of the study is the response rate with respect to the Patient Global Assessment (PGA) of Method of Pain Control. Secondary endpoints include; the patients’ assessment of pain intensity on a scale of 0-10 (NRS), quality of sleep, tolerability and assessment of Zalviso from the perspective of the healthcare professional (HCP) and patient. The latter is done with the aid of Patient and Nurse Ease of Care Questionnaires which were specifically developed to assess the usability of PCA systems in patients with post-operative pain. Quality of life will also be recorded by means of EQ-5D and the patient’s mobility/mobilisation will be assessed. \nThe study is sponsored and funded by the licence holder of Zalviso.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
17/NW/0337
Date of REC Opinion
6 Jul 2017
REC opinion
Further Information Favourable Opinion