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.
The eligible patients will be randomized into three groups, and will receive single doses of NPC-06 (high dose and low dose) or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
16
Infuse NPC-06 intravenously
Kawasaki Hospital
Okayama, Okayama-ken, Japan
The improvement of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score
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.
Time frame: 120 minutes after first administration
The improvement of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score
The change of NRS score at the time of evaluation compared to baseline.
Time frame: 120 minutes after first administration
The improvement of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score
The ratio of subjects who improve 2 or more points compared to baseline at 120 minutes after first administration.
Time frame: 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
The change of QOL score at the time of evaluation compared to baseline.
Time frame: 7 days
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