NPC-06 to Pain Associated With Acute Herpes Zoster (NCT05480553) | Clinical Trial Compass
CompletedPhase 3
NPC-06 to Pain Associated With Acute Herpes Zoster
Japan51 participantsStarted 2022-08-05
Plain-language summary
To confirm the pain relief effect and the safety of NPC-06 (fosphenytoin sodium hydrate) in patients with pain associated with acute herpes zoster in a placebo-controlled, double-blind, parallel-group, comparative manner.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients aged 18 years or older at the time of informed consent.
. Patients who are male or female.
. Patients who are inpatient or outpatient.
. Patients who are diagnosed with herpes zoster and have acute pain.
. Patients who are within 28 days after the onset of herpes zoster.
. Patients whose mean NRS pain score is 4 or higher despite the use of the following drugs during the period between 24 hours and 120 minutes before the study drug administration. During this period, one or two of the following drugs should have been used, and the same drug should have been used at least twice.
Exclusion criteria
. Patients who are suspected to be increased intracranial pressure.
. Patients who are complicated with epilepsy, serious mental or neuropsychiatric disorders (including dementia, Parkinson's disease, or schizophrenia) or consciousness disturbance.
. Patients who are being treated for malignancy. However, those who do not interfere with daily life and have good general condition may be included in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The change of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score
. Patients who are being treated for HIV infection or those who are receiving immunosuppressant (including biologics). However, those who do not interfere with daily life and have good general condition may be included in the study.
. Patients who are being treated for idiopathic trigeminal neuralgia.
. Patients who have other severe pain that may affect the assessment of pain associated with acute herpes zoster.
. Patients who have received non-opioid analgesics (excluding its sustained release formulations and topical drugs used for other sites than the target site for efficacy), Ca2＋ channel-α2δ ligands (excluding gabapentin), tramadol (excluding its sustained release formulations), or an extract from inflammatory rabbit skin inoculated by vaccinia virus during the period from 120 minutes before the study drug administration to the start of study drug administration.
. Patients who have received the following drugs during the period from 24 hours before the study drug administration to immediately before the study drug administration.