A Phase II study of M528101 for postherpetic neuralgia

JRCT ID: jRCT2031220415

Registered date:27/10/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Postherpetic neuralgia
• Date of first enrollment: 11/11/2022
• Target sample size: 18
• Study type: Interventional
• Intervention(s): Apply an appropriate amount of M5281 to the affected area

Outcome(s)

• Primary Outcome: Numerical Rating Scale (NRS)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Postherpetic neuralgia patients aged 18 years and older

Exclude criteria

(1)Patients with herpes zoster skin symptoms (edematous erythema, blisters, erosions, crusts) or other epidermal abrasions (erosions, ulcers, fissures) at the drug administration site (postherpetic neuralgia expression site)
(2)Patients with symptoms or treatment history (including neurodestructive drugs and radiofrequency thermocoagulation) that the investigator (subinvestigator) judges may affect the pain NRS evaluation of postherpetic neuralgia
(3)Patients who have or are currently undergoing drug treatment with opioids for postherpetic neuralgia

Related Information

• Primary Sponsor: Tomoyuki Nishiura