A randomized, parallel group, multi-center study of a fentanyl nasal spray compared with placebo nasal spray for postoperative pain management and prolonged open treatment over up to 120 hours postoperatively compared with intravenous patient-controlled analgesia using morphine
interventional
N/A
2 countries
12
The primary objective of the present trial is the assessment of the efficacy of Fentanyl Nasal Spray in combination with an applicator as compared to placebo for the management of postoperative pain. Pain caused by orthopedic surgery will serve as a model for postoperative pain. Evidence from the literature will be used to bridge analgesic effectiveness of nasal fentanyl from pain primarily caused by activation of nociceptors to visceral pain (e.g. caused by abdominal surgery).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 17, 2024
Actual (reported)Survival distribution in the period from start of treatment with the first dose of the study medication until terminating the trial due to inadequate analgesia as required by the patient or felt necessary by the investigator within the first 24 hours after start of treatment with non-terminating patients censored at 24 hours.
sum of ratings of pain intensity on a 11-point numeric rating scale at pre-defined points in time: at hours 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 after start of treatment (TotPaR)
sum of pain intensity difference ratings on a 11-point numeric rating scale comparing the pain rating before start of treatment (0) and ratings at pre-defined points in time (SPID): at hours 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120 after start of treatment (Patients will not be woken up for a postoperative measurement. The last observation carried forward method will be used to replace a missing value
percentage of patients who terminate the study due to inadequate analgesia during the 24-hours treatment period
percentage of patients who terminate the study due to any reason during the 24-hours treatment period
number of actuations administered
Acibadem Citi Clinic UMHAT Tokuda
Sofia, 1407, Bulgaria
MHAT „Dr. Ivan Seliminski” AD
Sliven, 8800, Bulgaria
Multiprofile Hospital For Active Treatment - Shumen AD
Shumen, 9705, Bulgaria
Project Manager
Managing Director: Dr. rer. med. Stefan Nardi-Hiebl
First Submitted
December 17, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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MHAT „Serdica“ EOOD
Sofia, 1303, Bulgaria
Umbal - Prof. D-R Stoyan Kirkovich AD
Stara Zagora, 6003, Bulgaria
University Multiprofile Hospital For Active Treatment Sofiamed OOD
Sofiya, 1797, Bulgaria
UMHAT "Medica Ruse" OOD
Ruse, 7013, Bulgaria
MHAT Skin systems, Base Doganovo
Elin Pelin, 2115, Bulgaria
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD
Gabrovo, 5300, Bulgaria
University Multiprofile Hospital For Active Treatment Pulmed Ltd.
Plovdiv, 4002, Bulgaria
MHAT "Lyulin" EAD
Sofia, 1336, Bulgaria
UKGM - University Hospital Marburg
Marburg, 35033, Germany