NPC-06 to Pain Associated With Acute Herpes Zoster

NCT ID: NCT05480553

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-05
• Study Completion Date: 2023-08-23

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.

Detailed Description

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

Conditions

Acute Pain in Herpes Zoster

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NPC-06

Group Type: EXPERIMENTAL

NPC-06

Intervention Type: 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.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients aged 18 years or older at the time of informed consent.

2. Patients who are male or female.

3. Patients who are inpatient or outpatient.

4. Patients who are diagnosed with herpes zoster and have acute pain.

5. Patients who are within 28 days after the onset of herpes zoster.

6. 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.

Exclusion Criteria

1. Patients who are suspected to be increased intracranial pressure.

2. Patients who are complicated with epilepsy, serious mental or neuropsychiatric disorders (including dementia, Parkinson's disease, or schizophrenia) or consciousness disturbance.

3. 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.

4. 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.

5. Patients who are being treated for idiopathic trigeminal neuralgia.

6. Patients who have other severe pain that may affect the assessment of pain associated with acute herpes zoster.

7. 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.

8. 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).

9. Patients who have sinus bradycardia or advanced conduction disturbance.

10. Patients who have a history of hypersensitivity to hydantoin.

11. Patients who are receiving drugs that are contraindicated in the package insert for fosphenytoin.

12. Patients who have received amenamevir during the period from 24 hours before the study drug administration to immediately before the study drug administration.

13. Patients who are complicated with meningitis or have symptoms of meningeal irritation.

14. Patients who have serious cardiac disease, respiratory disorder, or hepatic or renal dysfunction (as a guide, seriousness corresponding to Grade 3 of "Standards for Classification of Seriousness of Adverse Drug Reactions (Notification No. 80 of the Pharmaceutical Safety Notification ").

15. Patients who are receiving fosphenytoin, phenytoin, ethotoin, or a combination of these drugs or have received these drugs as adjuvant analgesics.

16. Patients who have participated in other clinical study within 3 months of the date of the screening test.

17. Pregnant women, lactating women or patients of childbearing potential during the study period.

18. Patients who are unable to give appropriate contraception in accordance with the instructions of the investigator or sub-investigator (hereafter, the investigators) during the period from after obtaining informed consent to the end of the follow-up period.

19. Other patients who are deemed inappropriate for participation in the study by the investigators.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nobelpharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Akemi Dermatology Clinic

Urayasu, Chiba, Japan

Fukuoka Tokushukai Hospital

Kasuga, Fukuoka, Japan

Chugoku Rosai Hospital

Kure, Hiroshima, Japan

Hakodate Central General Hospital

Hakodate, Hokkaido, Japan

Japanese Red Cross Society Himeji Hospital

Himeji, Hyōgo, Japan

Koga General Hospital

Koga, Ibaraki, Japan

Shonan Fujisawa Tokushukai Hospital

Fujisawa, Kanagawa, Japan

Toyama Dermatologic Clinic

Nichinan, Miyazaki, Japan

Yoshikawa Skin Clinic

Takatsuki, Osaka, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Sumi Clinic Dermatology Allergology

Meguro City, Tokyo, Japan

Kurobe City Hospital

Kurobe-shi, Toyama, Japan

University of Yamanashi Hospital

Chūō, Yamanashi, Japan

Fukuoka Kinen Hospital

Fukuoka, , Japan

Hakata Pain Clinic

Fukuoka, , Japan

Matsuda Tomoko Dermatological Clinic

Fukuoka, , Japan

National Hospital Organization Kanazawa Medical Center

Kanazawa, , Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, , Japan

Kawasaki Medical School General Medical Center

Okayama, , Japan

Shizuoka City Shizuoka Hospital

Shizuoka, , Japan

Countries

Japan

Other Identifiers

NPC-06-6

Identifier Type: -

Identifier Source: org_study_id