NPC-06 to Pain Associated With Acute Herpes Zoster

NCT05480553 | Completed Phase 3

• 1 other identifier: NPC-06-6
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Acute Pain in Herpes Zoster

Keywords

Herpes zoster; fosphenytoin; adjuvant analgesic; acute pain; NPC-06

Outcome Measures

Primary Outcomes (1)

• The change of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score

  Change in the NRS pain score from baseline at 120 minutes after the study drug administration.

  120 minutes after first administration

Study Arms (2)

NPC-06

EXPERIMENTAL

Drug: NPC-06

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

NPC-06 DRUG

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.

NPC-06

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or older at the time of informed consent.
• Patients who are male or female.
• Patients who are inpatient or outpatient.
• Patients who are diagnosed with herpes zoster and have acute pain.
• Patients who are within 28 days after the onset of herpes zoster.
• Patients whose mean NRS pain score is 4 or higher despite the use of the following drugs during the period between 24 hours and 120 minutes before the study drug administration. During this period, one or two of the following drugs should have been used, and the same drug should have been used at least twice.
• Non-opioid analgesics (excluding its sustained release formulations and topical drugs used for other sites than the target site for efficacy)
• Ca2＋ channels α2δ ligands (excluding gabapentin)
• Tramadol (excluding its sustained release formulations)
• An extract from inflammatory rabbit skin inoculated by vaccinia virus
• Patients whose NRS pain score immediately before the study drug administration is 4 or higher.
• (8) Patients who are able to perform NRS self-assessment appropriately. (9) Patients who gave written informed consent based on their own free will after receiving adequate explanation and fully understanding the details of the explanation in participating in the study.

You may not qualify if:

• Patients who are suspected to be increased intracranial pressure.
• Patients who are complicated with epilepsy, serious mental or neuropsychiatric disorders (including dementia, Parkinson's disease, or schizophrenia) or consciousness disturbance.
• Patients who are being treated for malignancy. However, those who do not interfere with daily life and have good general condition may be included in the study.
• Patients who are being treated for HIV infection or those who are receiving immunosuppressant (including biologics). However, those who do not interfere with daily life and have good general condition may be included in the study.
• Patients who are being treated for idiopathic trigeminal neuralgia.
• Patients who have other severe pain that may affect the assessment of pain associated with acute herpes zoster.
• Patients who have received non-opioid analgesics (excluding its sustained release formulations and topical drugs used for other sites than the target site for efficacy), Ca2＋ channel-α2δ ligands (excluding gabapentin), tramadol (excluding its sustained release formulations), or an extract from inflammatory rabbit skin inoculated by vaccinia virus during the period from 120 minutes before the study drug administration to the start of study drug administration.
• Patients who have received the following drugs during the period from 24 hours before the study drug administration to immediately before the study drug administration.
• Non-opioid analgesics (its sustained release formulations)
• Gabapentin
• Tramadol (its sustained release formulations)
• Opioid analgesics
• Steroidal anti-inflammatory drugs (systemic) for treatment of herpes zoster and pain associated with acute herpes zoster.
• Antidepressants, antiarrhythmics (excluding those in Vaughan Williams class Ⅱ), NMDA receptor antagonists, centrally acting muscle relaxants, and anesthetics (excluding topical drugs used for other sites than the target site for efficacy).
• Patients who have sinus bradycardia or advanced conduction disturbance.

Sponsors & Collaborators

• Nobelpharma: lead

Study Sites (20)

Akemi Dermatology Clinic

Urayasu, Chiba, Japan

Location

Fukuoka Tokushukai Hospital

Kasuga, Fukuoka, Japan

Location

Chugoku Rosai Hospital

Kure, Hiroshima, Japan

Location

Hakodate Central General Hospital

Hakodate, Hokkaido, Japan

Location

Japanese Red Cross Society Himeji Hospital

Himeji, Hyōgo, Japan

Location

Koga General Hospital

Koga, Ibaraki, Japan

Location

Shonan Fujisawa Tokushukai Hospital

Fujisawa, Kanagawa, Japan

Location

Toyama Dermatologic Clinic

Nichinan, Miyazaki, Japan

Location

Yoshikawa Skin Clinic

Takatsuki, Osaka, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Location

Sumi Clinic Dermatology Allergology

Meguro City, Tokyo, Japan

Location

Kurobe City Hospital

Kurobe-shi, Toyama, Japan

Location

University of Yamanashi Hospital

Chūō, Yamanashi, Japan

Location

Fukuoka Kinen Hospital

Fukuoka, Japan

Location

Hakata Pain Clinic

Fukuoka, Japan

Location

Matsuda Tomoko Dermatological Clinic

Fukuoka, Japan

Location

National Hospital Organization Kanazawa Medical Center

Kanazawa, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Japan

Location

Kawasaki Medical School General Medical Center

Okayama, Japan

Location

Shizuoka City Shizuoka Hospital

Shizuoka, Japan

Location

MeSH Terms

Conditions

Herpes Zoster; Acute Pain

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: July 29, 2022
• Study Start: August 5, 2022
• Primary Completion: May 29, 2023
• Study Completion: August 23, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (20)