Status:
TERMINATED
NPC-06 to Acute Pain in Herpes Zoster
Lead Sponsor:
Nobelpharma
Conditions:
Acute Pain in Herpes Zoster
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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 a...
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.
Eligibility Criteria
Inclusion
- 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 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.
- 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 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.
Exclusion
- 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 .
Key Trial Info
Start Date :
November 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04139330
Start Date
November 21 2019
End Date
February 28 2021
Last Update
July 1 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kawasaki Hospital
Okayama, Okayama-ken, Japan, 700-8505