NPC-06 to Acute Pain in Herpes Zoster

A Multicenter, Double-blind, Randomized, Placebo-controlled Parallel Group Trial to Investigate the Proof of Concept of NPC-06 to Acute Pain in Herpes Zoster

The purpose of this trial is to investigate the efficiency of pain relief and the safety of NPC-06 for the acute pain in herpes zoster in the placebo-controlled double-blind parallel group trial, in addition to explore the effective concentration of NPC-06.

Study Overview

• Status: Terminated
• Conditions: Acute Pain in Herpes Zoster
• Intervention / Treatment: Drug: NPC-06

Detailed Description

The eligible patients will be randomized into three groups, and will receive single doses of NPC-06 (high dose and low dose) or placebo.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Okayama
    • Okayama city, Okayama, Japan, 700-8505
      • Kawasaki Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 20 years old or over at the time of informed consent.
2. Both genders.
3. Patients who have acute rash (either erythema or papule or bulla or pustule, or more), except who have crust more than 20% of entire rash at just before the time of the first administration.
4. Patients who are administrated antiviral drug for herpes zoster at the time of the first administration.
5. Patients who are administrated non-opioid analgesics(acetaminophen, NSAIDs) for herpes zoster at the time of the first administration.

6. Patients who the NRS score at the time of below evaluation point is higher than 4.

   • 120 minutes before the start of infusion.
   • Just before the start of infusion.
7. Patients who the therapeutic effect of non-opioid analgesics for herpes zoster has been insufficient.
8. Patients who can admit to hospital for the all assessment duration from first administration until next day (including hospitalized patient).
9. Patients or his/her guardian who give a written informed consent in understanding and willingness after having received enough explanation regarding the study participation.

Exclusion Criteria:

1. Patients who cannot evaluate NRS by themselves.
2. Patients who are suspected to intracranial pressure increase.
3. Patients who have epilepsy, serious psychiatric or serious neurological disease (i. e. dementia, Parkinson disease and schizophrenic disorder) or consciousness disorder.
4. Patients who have malignant tumors (except for patients who have no signs of recurrence under treatment) or patients who are under treatment for HIV or patients who are receiving immunosuppressant.
5. Patients who have complicated idiopathic trigeminal neuralgia.
6. Patients who have other serious pain which may affect the evaluation of acute herpetic pain.
7. Patients who are receiving opioids or steroids(systemic).
8. Patients who have sinus bradycardia or serious disturbance of conduction system.
9. Patients who have history of hypersensitivity against hydantoin compound.
10. Patients who are receiving tadalafil (for pulmonary hypertension), rilpivirine, asunaprevir, daclatasvir, vaniprevir, macitentan or sofosbuvir.
11. Patients who are receiving medications for neuropathic pain, antidepressants, antiarrhythmic drugs, N-methyl-D-aspartate receptor antagonists, muscle relaxants, local anesthetics, an extract from inflammatory rabbit skin inoculated by vaccinia virus, Chinese herbal medications for analgesia, vitamin B12.
12. Patients who are receiving amenamevir.
13. Patients who have meningitis or meningeal irritation signs.
14. Patients who have complications such as serious heart disease, hepatic function disorder or renal function disorder which severity are considered by investigator as grade 3 or more severe with reference to ''Concerning classification criteria for seriousness of adverse drug reactions of medical agents'' .
15. Patients who are receiving fosphenytoin, phenytoin or ethotoin and combination drug including these or have taken these drugs as adjuvant therapy for pain .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: NPC-06 (high dose); Infuse diluted NPC-06 18mg/kg solution with 3 to 4 times volume of saline. Administarate NPC-06 gradually (slowly) over 18 minutes.	Drug: NPC-06; Infuse NPC-06 intravenously
EXPERIMENTAL: NPC-06 (low dose); Infuse diluted NPC-06 12mg/kg solution with 3 to 4 times volume of saline. Administarate NPC-06 gradually (slowly) over 12 minutes	Drug: NPC-06; Infuse NPC-06 intravenously
PLACEBO_COMPARATOR: NPC-06 (placebo); Infuse NPC-06 (placebo) over 12 minutes or 18 minutes	Drug: NPC-06; Infuse NPC-06 intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The improvement of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score	The average change (slope) of NRS score at the time of evaluation, which is measured before the first administration, 30, 60, 90 and 120 minutes after the first administration.	120 minutes after first administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The improvement of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score	The change of NRS score at the time of evaluation compared to baseline.	120 minutes after first administration
The improvement of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score	The ratio of subjects who improve 2 or more points compared to baseline at 120 minutes after first administration.	120 minutes after first administration
The improvement of QOL(EQ-5D-5L, Max 1.000, Min -0.111, higher scores mean a better outcome) score	The change of QOL score at the time of evaluation compared to baseline.	7 days

Collaborators and Investigators

• Sponsor: Nobelpharma

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 21, 2019
• Primary Completion (ACTUAL): February 28, 2021
• Study Completion (ACTUAL): February 28, 2021

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (ACTUAL): October 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Pain; Neurologic Manifestations; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Varicella Zoster Virus Infection; Acute Pain; Herpes Zoster; Herpes Simplex
• Other Study ID Numbers: NPC-06-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No