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
Overview
- Phase
- Phase 2
- Intervention
- NPC-06
- Conditions
- Acute Pain in Herpes Zoster
- Sponsor
- Nobelpharma
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- The improvement of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
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 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
- •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).
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 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.
Arms & Interventions
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.
Intervention: NPC-06
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
Intervention: NPC-06
NPC-06 (placebo)
Infuse NPC-06 (placebo) over 12 minutes or 18 minutes
Intervention: NPC-06
Outcomes
Primary Outcomes
The improvement of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score
Time Frame: 120 minutes after first administration
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.
Secondary Outcomes
- 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)