51
Participants
Start Date
August 5, 2022
Primary Completion Date
May 29, 2023
Study Completion Date
August 23, 2023
NPC-06
"1. Initial dose (Day 1) \<Dose\> An 18 mg/kg of NPC-06 will be injected by intravenous drip infusion once daily. The maximum dose of the test drug should not exceed 1,200 mg as fosphenytoin sodium.~ \<Administration method\> Dilute the study drug 3 to 4-fold using physiological saline for intravenous infusion and then administer the solution over 18 minutes.~2. Maintenance dose(Day 2~7) Maintenance dose on the next day (Day 2) after the initial dose will be mandatory, and will be dosed up to 6 days. Maintenance dose on Day 3 and thereafter will follow the transition criteria for maintenance dose.~\<Dose\> A 7.5 mg/kg of NPC-06 will be injected as needed by intravenous drip infusion once daily. The maximum dose of NPC-06 should not exceed 500 mg as fosphenytoin sodium.~\<Administration method\> Dilute the study drug 3-to 4-fold using physiological saline for intravenous infusion and then administer the solution over 7 minutes and 30 seconds."
Placebo
"1. Initial dose (Day 1) \<Dose\> A placebo will be injected by intravenous drip infusion once daily. \<Administration method\> Dilute the study drug 3 to 4-fold using physiological saline for intravenous infusion and then administer the solution over 18 minutes.~2. Maintenance dose(Day 2~7) Maintenance dose on the next day (Day 2) after the initial dose will be mandatory, and will be dosed up to 6 days. Maintenance dose on Day 3 and thereafter will follow the transition criteria for maintenance dose.~\<Dose\> A placebo will be injected as needed by intravenous drip infusion once daily. Dilute the study drug 3-to 4-fold using physiological saline for intravenous infusion and then administer the solution over 7 minutes and 30 seconds."
Akemi Dermatology Clinic, Urayasu
Fukuoka Tokushukai Hospital, Kasuga
Chugoku Rosai Hospital, Kure
Hakodate Central General Hospital, Hakodate
Japanese Red Cross Society Himeji Hospital, Himeji
Koga General Hospital, Koga
Shonan Fujisawa Tokushukai Hospital, Fujisawa
Toyama Dermatologic Clinic, Nichinan
Yoshikawa Skin Clinic, Takatsuki
Juntendo University Hospital, Bunkyo-ku
Sumi Clinic Dermatology Allergology, Meguro City
Kurobe City Hospital, Kurobe-shi
University of Yamanashi Hospital, Chūō
Fukuoka Kinen Hospital, Fukuoka
Hakata Pain Clinic, Fukuoka
Matsuda Tomoko Dermatological Clinic, Fukuoka
National Hospital Organization Kanazawa Medical Center, Kanazawa
University Hospital Kyoto Prefectural University of Medicine, Kyoto
Kawasaki Medical School General Medical Center, Okayama
Shizuoka City Shizuoka Hospital, Shizuoka
Lead Sponsor
Nobelpharma
INDUSTRY