109
Participants
Start Date
December 16, 2019
Primary Completion Date
September 25, 2024
Study Completion Date
September 25, 2024
Dronabinol in Oral Dosage Form
Titration period for 4 weeks: titration according to tolerability from 2.5 mg (3 x 1 droplet) up to 30 mg (3 x 12 droplets) per day; dose increased by 2.5 mg (3 x 1 droplet) every other day Maintenance period for 12 weeks: individually tolerated maximum dose (up to 30 mg ≙ 3 x 12 droplets) at end of titration period will be continued for maintenance treatment Tapering period for 2 weeks: dose is decreased every other day by 5 mg (3 x 2 droplets) Safety follow-up: 4 weeks after end of treatment
Placebo in Oral Dosage Form
Titration period for 4 weeks: titration according to tolerability from 3 x 1 droplet up to 3 x 12 droplets per day; dose increased by 3 x 1 droplet every other day Maintenance period for 12 weeks: individually tolerated maximum dose (up to 3 x 12 droplets) at end of titration period will be continued for maintenance treatment Tapering period for 2 weeks: dose is decreased every other day by 3 x 2 droplets Safety follow-up: 4 weeks after end of treatment
Hanusch Krankenhaus der Wiener Gebietskrankenkasse, Vienna
Klinikum Wels-Grieskirchen GmbH, Abteilung für Innere Medizin IV, Wels
IIIrd Medical Department, Private Medical University Hospital Salzburg, Salzburg
KH Zams, Innere Medizin, Internistische Onkologie u. Haematologie, Zams
LKH Hochsteiermark - Standort Leoben Abteilung für Innere Medizin und Hämatologie und internistische Onkologie, Leoben
KABEG-Klinikum Klagenfurt am Woerthersee, Abteilung f. Anaesthesie u. Intensivmedizin, Klagenfurt
Krankenhaus d. Barmherzigen Brüder, Abt. f. Innere Medizin, Sankt Veit an der Glan
Universitätsmedizin Göttingen Abt. f. Gastroenterologie, gastrointestinale Onkologie u. Endokrinologie, Göttingen
München Klinik Neuperlach, München
Pyhrn-Eisenwurzen Klinikum Steyr, Interne Medizin II, Steyr
Marienhospital Onkologie, Hämatologie, Palliativmedizin, Stuttgart
Collaborators (1)
Medical University of Graz
OTHER
Unidata Geodesign
UNKNOWN
Bionorica SE
INDUSTRY
Arbeitsgemeinschaft medikamentoese Tumortherapie
OTHER