Last updated: June 29, 2021
Sponsor: Nobelpharma
Overall Status: Terminated
Phase
2
Condition
Shingles
Chickenpox (Varicella Zoster Infection)
Herpes Simplex Infections
Treatment
N/AClinical Study ID
NCT04139330
NPC-06-5
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 20 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 thefirst administration.
- Patients who are administrated antiviral drug for herpes zoster at the time of thefirst administration.
- Patients who are administrated non-opioid analgesics(acetaminophen, NSAIDs) for herpeszoster at the time of the first administration.
- 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.
- Patients who the therapeutic effect of non-opioid analgesics for herpes zoster hasbeen insufficient.
- Patients who can admit to hospital for the all assessment duration from firstadministration until next day (including hospitalized patient).
- 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:
- 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 ofrecurrence under treatment) or patients who are under treatment for HIV or patientswho are receiving immunosuppressant.
- Patients who have complicated idiopathic trigeminal neuralgia.
- Patients who have other serious pain which may affect the evaluation of acute herpeticpain.
- 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 vacciniavirus, 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 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'' .
- 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
Connect with a study center
Kawasaki Hospital
Okayama city, Okayama 700-8505
JapanSite Not Available

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