NPC-06 to Acute Pain in Herpes Zoster

Last updated: June 29, 2021
Sponsor: Nobelpharma
Overall Status: Terminated

Phase

2

Condition

Shingles

Chickenpox (Varicella Zoster Infection)

Herpes Simplex Infections

Treatment

N/A

Clinical Study ID

NCT04139330
NPC-06-5
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thefirst administration.
  4. Patients who are administrated antiviral drug for herpes zoster at the time of thefirst administration.
  5. Patients who are administrated non-opioid analgesics(acetaminophen, NSAIDs) for herpeszoster 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.
  1. Patients who the therapeutic effect of non-opioid analgesics for herpes zoster hasbeen insufficient.
  2. Patients who can admit to hospital for the all assessment duration from firstadministration until next day (including hospitalized patient).
  3. Patients or his/her guardian who give a written informed consent in understanding andwillingness after having received enough explanation regarding the studyparticipation.

Exclusion

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 ofrecurrence under treatment) or patients who are under treatment for HIV or patientswho 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 herpeticpain.
  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 vacciniavirus, 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 functiondisorder or renal function disorder which severity are considered by investigator asgrade 3 or more severe with reference to ''Concerning classification criteria forseriousness of adverse drug reactions of medical agents'' .
  15. Patients who are receiving fosphenytoin, phenytoin or ethotoin and combination drugincluding these or have taken these drugs as adjuvant therapy for pain .

Study Design

Total Participants: 16
Study Start date:
November 21, 2019
Estimated Completion Date:
February 28, 2021

Study 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.

Connect with a study center

  • Kawasaki Hospital

    Okayama city, Okayama 700-8505
    Japan

    Site Not Available

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