NPC-06 to Acute Pain in Herpes Zoster

NCT04139330 | Terminated Phase 2

• 1 other identifier: NPC-06-5
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Pain in Herpes Zoster

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  120 minutes after first administration

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

  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

  7 days

Study Arms (3)

NPC-06 (high dose)

EXPERIMENTAL

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

NPC-06 (low dose)

EXPERIMENTAL

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

NPC-06 (placebo)

PLACEBO COMPARATOR

Infuse NPC-06 (placebo) over 12 minutes or 18 minutes

Drug: NPC-06

Interventions

NPC-06 DRUG

Infuse NPC-06 intravenously

NPC-06 (high dose); NPC-06 (low dose); NPC-06 (placebo)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or over at the time of informed consent.
• Both genders.
• 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.
• Patients who are administrated antiviral drug for herpes zoster at the time of the first administration.
• Patients who are administrated non-opioid analgesics(acetaminophen, NSAIDs) for herpes zoster at the time of the first administration.
• Patients who the NRS score at the time of below evaluation point is higher than 4.
• minutes before the start of infusion.
• Just before the start of infusion.
• Patients who the therapeutic effect of non-opioid analgesics for herpes zoster has been insufficient.
• Patients who can admit to hospital for the all assessment duration from first administration until next day (including hospitalized patient).
• Patients or his/her guardian who give a written informed consent in understanding and willingness after having received enough explanation regarding the study participation.

You may not qualify if:

• Patients who cannot evaluate NRS by themselves.
• Patients who are suspected to intracranial pressure increase.
• Patients who have epilepsy, serious psychiatric or serious neurological disease (i. e. dementia, Parkinson disease and schizophrenic disorder) or consciousness disorder.
• 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.
• Patients who have complicated idiopathic trigeminal neuralgia.
• Patients who have other serious pain which may affect the evaluation of acute herpetic pain.
• Patients who are receiving opioids or steroids(systemic).
• Patients who have sinus bradycardia or serious disturbance of conduction system.
• Patients who have history of hypersensitivity against hydantoin compound.
• Patients who are receiving tadalafil (for pulmonary hypertension), rilpivirine, asunaprevir, daclatasvir, vaniprevir, macitentan or sofosbuvir.
• 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.
• Patients who are receiving amenamevir.
• Patients who have meningitis or meningeal irritation signs.
• 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'' .
• Patients who are receiving fosphenytoin, phenytoin or ethotoin and combination drug including these or have taken these drugs as adjuvant therapy for pain .

Sponsors & Collaborators

• Nobelpharma: lead

Study Sites (1)

Kawasaki Hospital

Okayama, Okayama-ken, 700-8505, Japan

Location

Related Publications (1)

• Iseki M, Yamamoto T, Ogawa Y, Majima Y, Abe Y, Watanabe D, Amaya F, Hasegawa T, Inafuku K, Kosugi T, Nomura Y, Deguchi T, Hamada T, Shimizu K, Arai S, Takahashi M, Hamada I, Ishikawa Y, Kawashima M. Efficacy and safety of intravenous fosphenytoin for patients with acute herpes zoster-associated pain: A placebo-controlled randomized trial. J Dermatol. 2024 Feb;51(2):234-242. doi: 10.1111/1346-8138.17054. Epub 2023 Dec 27.

  PMID: 38149403 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 25, 2019
• Study Start: November 21, 2019
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: July 1, 2021

Record last verified: 2020-06

Locations

JP (1)