Nasal Fentanyl and Buccal Midazolam for Dying Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 23, 2017

Primary Completion Date

February 28, 2018

Study Completion Date

February 28, 2018

Conditions
Terminal Cancer
Interventions
DRUG

PecFent and Epistatus

"PecFent will be supplied by Archimedes Pharma as two strengths of nasal spray solution at 1000 or 4000 mcg/mL fentanyl (as citrate). One spray contains 100 mcg or 400 mcg fentanyl (as citrate). Each bottle contains 1.55 ml ensuring delivery of 8 sprays of 100 or 400 mcg fentanyl (as citrate). PecFent is a commercially available product and packaging will be in accordance with the manufacturing authorisations (EU/1/10/644/001, EU/1/10/644/002, EU/1/10/644/005, EU/1/10/644/003, EU/1/10/644/004, EU/1/10/644/006).~Epistatus will be supplied by Special Products Ltd. as buccal solution, packed in bottles containing solution for up to 4 x 1 ml doses, as per Specials licence. A pack also includes 4 x oral syringes used to administer the solution to the buccal cavity on either side of the mouth."

DRUG

Standard subcutaneous medication

"Subcutaneous as needed medication will include:~* Opioids for pain or dyspnoea~ * Diamorphine~ * Oxycodone~ * Fentanyl~* Benzodiazepine and / or anti-psychotic for agitation~ * Midazolam~ * Levomepromazine~ * Haloperidol Anti-emetic for nausea~* Cyclizine~* Metoclopramide~* Haloperidol~* Levomepromazine~* Anti-secretory drug for respiratory secretions~* Glycopyrronium~* Hyoscine butylbromide~* Hyoscine hydrobromide"

DRUG

Epistatus Alone

"Epistatus will be supplied by Special Products Ltd. as buccal solution, packed in bottles containing solution for up to 4 x 1 ml doses, as per Specials licence. A pack also includes 4 x oral syringes used to administer the solution to the buccal cavity on either side of the mouth."

Trial Locations (1)

GL53 0QJ

Sue Ryder Leckhampton Court Hospice, Cheltenham

All Listed Sponsors
lead

Gloucestershire Hospitals NHS Foundation Trust

OTHER

NCT02009306 - Nasal Fentanyl and Buccal Midazolam for Dying Patients | Biotech Hunter | Biotech Hunter