A Study of ONO-1110 in Patients With Postherpetic Neuralgia
A Phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-center Trial to Evaluate the Efficacy and Safety of ONO-1110 in Patients With Postherpetic Neuralgia
2 other identifiers
interventional
140
1 country
31
Brief Summary
To evaluate the efficacy and safety of ONO-1110 in Japanese patients with postherpetic neuralgia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2025
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2024
CompletedFirst Posted
Study publicly available on registry
November 27, 2024
CompletedStudy Start
First participant enrolled
February 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
March 2, 2026
February 1, 2026
1.4 years
November 24, 2024
February 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in weekly mean of average pain score (last 7-day mean of past 24-hour average pain scores [NRS] in the pain diary) from baseline to Week 8 of the treatment period
Up to 15 weeks
Adverse Events
Up to 15 weeks
Secondary Outcomes (9)
Change in weekly mean of average pain score from baseline to each week
Up to 15 weeks
30%- and 50%-responder rates based on the weekly mean of average pain score (proportions of participants whose weekly mean of average pain score has decreased by 30% and 50% from baseline, respectively)
Up to 15 weeks
Change in weekly mean of worst pain score (last 7-day mean of past 24-hour worst pain scores [NRS] in the pain diary) from baseline to each week
Up to 15 weeks
30%- and 50%-responder rates based on the weekly mean of worst pain score (proportions of participants whose weekly mean of worst pain score has decreased by 30% and 50% from baseline, respectively)
Up to 15 weeks
Change in Brief pain inventory-short form (BPI-SF) score from baseline
Up to 15 weeks
- +4 more secondary outcomes
Study Arms (2)
ONO-1110
EXPERIMENTALONO-1110 tablets once a day
Placebo
PLACEBO COMPARATORPlacebo tablets once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Kamezawa Clinic
Aichi, Japan
Kimura Clinic
Aichi, Japan
Fukuoka Tokushukai Hospital
Fukuoka, Japan
Southern Tohoku General Hospital
Fukushima, Japan
Central Japan International Medical Center
Gifu, Japan
National Hospital Organization Kure Medical Center
Hiroshima, Japan
National Hospital Organization Hokkaido Medical Center
Hokkaido, Japan
Nishinomiya Municipal Central Hospital
Hyōgo, Japan
Mito Saiseikai General Hospital
Ibaraki, Japan
Kawasaki Municipal Hospital
Kanagawa, Japan
Konan Hidamari Pain Clinic
Kanagawa, Japan
Nomura Dermatology Clinic
Kanagawa, Japan
Tai Clinic
Kanagawa, Japan
Yokohama City Minato Red Cross Hospital
Kanagawa, Japan
Junwakai Memorial Hospital
Miyazaki, Japan
Medical Corporation Toyama Dermatology
Miyazaki, Japan
Yuaikai Tomishiro Chuo Hospital
Okinawa, Japan
Morimoto Clinic
Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
Osaka, Japan
Osaka Metropolitan University Hospital
Osaka, Japan
Medical Corporation Fujigaki Clinic
Ōita, Japan
Chutoen General Medical Center
Shizuoka, Japan
Shizuoka Rehabili Pain Clinic
Shizuoka, Japan
Fukuuchi Pain Clinic
Tokyo, Japan
Fukuwa Clinic
Tokyo, Japan
Futaki Skin Care Clinic
Tokyo, Japan
Juntendo University Hospital
Tokyo, Japan
Mitaka Pain Clinic
Tokyo, Japan
Nishiogi Pain Clinic
Tokyo, Japan
Tokyo-Eki Center-Building Clinic
Tokyo, Japan
Yamanashi Prefectural Central Hospital
Yamanashi, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Project Leader
Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2024
First Posted
November 27, 2024
Study Start
February 12, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
March 2, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share