Postherpetic Neuralgia
Conditions
Keywords
ONO-1110, ONO-1110-04, Postherpetic Neuralgia, PHN
Brief summary
To evaluate the efficacy and safety of ONO-1110 in Japanese patients with postherpetic neuralgia
Interventions
DRUGONO-1110
ONO-1110 tablets once a day
DRUGPlacebo
Placebo tablets once daily
Sponsors
Ono Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Change in Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) score from baseline | Up to 15 weeks |
| Patient Global Impression of Change (PGIC) score | Up to 15 weeks |
| Change in Hospital Anxiety and Depression Scale (HADS) score from baseline | Up to 15 weeks |
| Plasma ONO-1110 concentrations | Up to 15 weeks |
Countries
Japan
Contacts
STUDY_DIRECTORProject Leader
Ono Pharmaceutical Co., Ltd.
Outcome results
None listed