A Study of ONO-1110 in Patients With Postherpetic Neuralgia

NCT ID: NCT06708416

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-12

Study Completion Date

2026-08-31

Brief Summary

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

Detailed Description

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Conditions

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Postherpetic Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ONO-1110

ONO-1110 tablets once a day

Group Type EXPERIMENTAL

ONO-1110

Intervention Type DRUG

ONO-1110 tablets once a day

Placebo

Placebo tablets once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets once daily

Interventions

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ONO-1110

ONO-1110 tablets once a day

Intervention Type DRUG

Placebo

Placebo tablets once daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Project Leader

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

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Kamezawa Clinic

Aichi, , Japan

Site Status RECRUITING

Kimura Clinic

Aichi, , Japan

Site Status RECRUITING

Fukuoka Tokushukai Hospital

Fukuoka, , Japan

Site Status RECRUITING

Southern Tohoku General Hospital

Fukushima, , Japan

Site Status RECRUITING

Central Japan International Medical Center

Gifu, , Japan

Site Status RECRUITING

National Hospital Organization Kure Medical Center

Hiroshima, , Japan

Site Status RECRUITING

National Hospital Organization Hokkaido Medical Center

Hokkaido, , Japan

Site Status RECRUITING

Nishinomiya Municipal Central Hospital

Hyōgo, , Japan

Site Status RECRUITING

Mito Saiseikai General Hospital

Ibaraki, , Japan

Site Status RECRUITING

Kawasaki Municipal Hospital

Kanagawa, , Japan

Site Status RECRUITING

Konan Hidamari Pain Clinic

Kanagawa, , Japan

Site Status RECRUITING

Tai Clinic

Kanagawa, , Japan

Site Status RECRUITING

Yokohama City Minato Red Cross Hospital

Kanagawa, , Japan

Site Status RECRUITING

Junwakai Memorial Hospital

Miyazaki, , Japan

Site Status RECRUITING

Medical Corporation Toyama Dermatology

Miyazaki, , Japan

Site Status RECRUITING

Yuaikai Tomishiro Chuo Hospital

Okinawa, , Japan

Site Status RECRUITING

Morimoto Clinic

Osaka, , Japan

Site Status RECRUITING

Osaka Metropolitan University Hospital

Osaka, , Japan

Site Status RECRUITING

Medical Corporation Fujigaki Clinic

Ōita, , Japan

Site Status RECRUITING

Shizuoka Rehabili Pain Clinic

Shizuoka, , Japan

Site Status RECRUITING

Fukuuchi Pain Clinic

Tokyo, , Japan

Site Status RECRUITING

Fukuwa Clinic

Tokyo, , Japan

Site Status RECRUITING

Futaki Skin Care Clinic

Tokyo, , Japan

Site Status RECRUITING

Juntendo University Hospital

Tokyo, , Japan

Site Status RECRUITING

Mitaka Pain Clinic

Tokyo, , Japan

Site Status RECRUITING

Nishiogi Pain Clinic

Tokyo, , Japan

Site Status RECRUITING

Tokyo-Eki Center-Building Clinic

Tokyo, , Japan

Site Status RECRUITING

Yamanashi Prefectural Central Hospital

Yamanashi, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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North America Clinical Trial Support Desk

Role: CONTACT

+18665877745(Toll-Free)

International Clinical Trial Support Desk

Role: CONTACT

+17162141777(Standard)

Other Identifiers

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jRCT2031240504

Identifier Type: REGISTRY

Identifier Source: secondary_id

ONO-1110-04

Identifier Type: -

Identifier Source: org_study_id

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