NCT05480553

NPC-06 to Pain Associated With Acute Herpes Zoster

A Phase 3, Placebo-Controlled, Double-Blind Controlled Study of NPC-06 in Patients With Pain Associated With Acute Herpes Zoster

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Nobelpharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To confirm the pain relief effect and the safety of NPC-06 (fosphenytoin sodium hydrate) in patients with pain associated with acute herpes zoster in a placebo-controlled, double-blind, parallel-group, comparative manner.

Detailed description

The eligible patients will be randomized into two groups, and will receive NPC-06 or placebo.

Conditions

• Acute Pain in Herpes Zoster

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-05
• Primary completion: 2023-05-29
• Completion: 2023-08-23
• First posted: 2022-07-29
• Last updated: 2023-09-28

Locations

20 sites across 1 country: Japan