NPC-06 to Pain Associated With Acute Herpes Zoster

PHASE3CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

August 5, 2022

Primary Completion Date

May 29, 2023

Study Completion Date

August 23, 2023

Conditions
Acute Pain in Herpes Zoster
Interventions
DRUG

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."

DRUG

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."

Trial Locations (20)

Unknown

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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Nobelpharma

INDUSTRY

NCT05480553 - NPC-06 to Pain Associated With Acute Herpes Zoster | Biotech Hunter | Biotech Hunter