A Study of ONO-1110 in Patients With Postherpetic Neuralgia

Ono Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Postherpetic Neuralgia

Treatments: Drug: ONO-1110; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06708416

ONO-1110-04

jRCT2031240504 (Registry Identifier)

Details and patient eligibility

About

To evaluate the efficacy and safety of ONO-1110 in Japanese patients with postherpetic neuralgia

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese (both sexes)
• Age (at the time of informed consent): 18 years and older
• Outpatient
• Patients with persistent pain ≥3 months (90 days) after the onset of herpes zoster
• Patients who are considered capable of understanding the study procedures and completing the pain diary and questionnaires appropriately by the investigator (sub-investigator)

Exclusion criteria

• Patients who previously underwent neurodestruction or neurosurgical therapy for PHN
• Patients with pain other than PHN that may affect assessments in this study
• Patients with any skin condition related to the site of herpes zoster that may affect assessments in this study
• Patients with a past history of or concurrent neurologic diseases that may affect assessments in this study
• Patients with concurrent psychiatric diseases that may affect assessments in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups, including a placebo group

ONO-1110

Experimental group

Description:

ONO-1110 tablets once a day

Treatment:

Drug: ONO-1110

Placebo

Placebo Comparator group

Description:

Placebo tablets once daily

Treatment:

Drug: Placebo