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 range18 Years

SexALL

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.
✕. 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.

What they're measuring

The change of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score

Timeframe: 120 minutes after first administration

Trial details

NCT IDNCT05480553

SponsorNobelpharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-29

View on ClinicalTrials.gov More Acute Pain in Herpes Zoster trials