NPC-06 to Acute Pain in Herpes Zoster (NCT04139330) | Clinical Trial Compass
TerminatedPhase 2
NPC-06 to Acute Pain in Herpes Zoster
Stopped: Low recruitment
Japan16 participantsStarted 2019-11-21
Plain-language 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.
Who can participate
Age range20 Years
SexALL
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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 4.
✓. 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.
✕
What they're measuring
1
The improvement of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score
. 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.