Phase III study of TH-004 in patients with postherpetic neuralgia

JRCT ID: jRCT2031240211

Registered date:09/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Postherpetic neuralgia
• Date of first enrollment: 05/07/2024
• Target sample size: 160
• Study type: Interventional

Intervention(s)

< TH-004 group >
Generic name: Lidocaine (gel)
Method of administration: Apply to the painful area three times daily

< Comparison group >
Generic name: Placebo (gel)
Method of administration: Apply to the painful area three times daily

Outcome(s)

Primary Outcome

Efficacy:
Analgesic response during the double-blind phase

Secondary Outcome

Efficacy
Safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Japanese patients aged 18 years or older at the time of informed consent.
(2) Patients diagnosed with postherpetic neuralgia (PHN) who continue to have pain at least 3 months after the onset of herpes zoster at the time of informed consent.
(3) closed to the public (NRS score).
(4) Patients who are able to comply with the rules during clinical trial participation, undergo examinations and tests prescribed in the clinical trial procedures, report subjective symptoms, etc., and respond appropriately to the patient diary.
(5) Patients who are fully informed about and understand the purpose and content of the clinical trial, expected drug efficacy, pharmacological effects, and risks and who have given voluntary written consent.

Exclude criteria

(1) closed to the public (NRS score).
(2) Patients who underwent nerve block surgery for PHN (Nerve destruction with chemicals using phenol and ethanol, high-frequency thermocoagulation, etc.) or who have undergone pulse radiofrequency, etc. within 30 days before the start of the screening period. Patients who underwent nerve block surgery, etc. that does not involve nerve destruction.
(3) Patients who used strong opioid analgesics within 30 days before the start of the screening period.
(4) Patients who have had a change in the dosage and administration of drugs with analgesic action (including prescriptions for analgesia) for PHN or neuropathic pain, such as antidepressants, antiepileptics, anxiolytics, antipsychotics, N-methyl-D-aspartate (NMDA) receptor antagonists, corticosteroids, alpha-2-adrenoceptor agonists, NSAIDs, acetaminophen, weak opioids, and Chinese medicines since 2 weeks before the start of the screening period, or patients who are judged to have an impact on the analgesic effect of TH-004 on PHN (excluding topical agents intended for local action).
(5) Patients with other pain not related to PHN at the beginning of the screening period that may affect the assessment of PHN.
(6) Patients with skin symptoms (eczema, ulcers, erosion, etc.) at the PHN site that may affect the assessment of pain or safety.
(7) Patients with cardiac conduction disorders.
(8) Patients who have previously been treated with topical lidocaine and judged ineffective for PHN.
(9) Patients with hypersensitivity to amide-type local anesthetics, including lidocaine.
(10) Patients who had complications and/or a history of cardiovascular disease, hepatic disease, renal disease, endocrine disease, gastrointestinal disease, hematologic disease, respiratory disease, or central/neuropsychiatric disease within 12 months before the start of the screening period, and patients who were judged inappropriate by the investigator (sub investigator).
(11) For non-menopausal women, patients with a positive pregnancy test at screening or those who are breastfeeding.
(12) For women of childbearing potential, or for men with a childbearing partner, who cannot consent to abstinence or the use of effective contraception as part of their lifestyle from the time of informed consent until 28 days after the last dose of study drug.
(13) Patients who are currently participating in another study or who have participated in another study within 30 days of obtaining informed consent.
(14) Other patients judged by the investigator (sub investigator) to be unsuitable for the study.

Related Information

• Primary Sponsor: Arita Kazuhiro