A Study of ONO-1110 in Patients With Postherpetic Neuralgia

Phase 2CompletedNCT06708416

Ono Pharmaceutical Co., Ltd.142 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

142

Conditions

Postherpetic Neuralgia

Interventions

ONO-1110DRUG

ONO-1110 tablets once a day

PlaceboDRUG

Placebo tablets once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (31)

Kamezawa Clinic

Aichi, Japan

Outcomes

Primary Outcomes

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

Time frame: Up to 15 weeks

Adverse Events

Time frame: Up to 15 weeks

Secondary Outcomes

Change in weekly mean of average pain score from baseline to each week

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: Up to 15 weeks

Change in Brief pain inventory-short form (BPI-SF) score from baseline

Time frame: Up to 15 weeks

Change in Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) score from baseline

Time frame: Up to 15 weeks

Patient Global Impression of Change (PGIC) score

Time frame: Up to 15 weeks

Data from ClinicalTrials.gov

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