Evaluating ONO-1110 for treating 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
This study is testing a new medication called ONO-1110 to see if it can help Japanese patients with long-lasting pain from shingles feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ono Pharmaceutical Co. Ltd Industry-sponsored |
| Locations | 1 site (Ōita) |
| Trial ID | NCT06708416 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy and safety of ONO-1110 in Japanese patients suffering from postherpetic neuralgia, a condition characterized by persistent pain following herpes zoster. Participants will be randomly assigned to receive either ONO-1110 or a placebo, with the primary focus on measuring pain relief and overall improvement in quality of life. The study will include patients aged 18 and older who have experienced pain for at least three months after the onset of herpes zoster. The trial will involve regular assessments through pain diaries and questionnaires to evaluate treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are Japanese adults aged 18 and older with persistent pain for at least three months following herpes zoster.
Not a fit: Patients with other pain conditions or those who have undergone previous neurosurgical therapies for postherpetic neuralgia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate chronic pain for patients suffering from postherpetic neuralgia.
How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in treating chronic pain conditions with novel therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ōita
- Medical Corporation Fujigaki Clinic — Ōita, Japan (Recruiting)
Study contacts
- Study coordinator: Ono Pharmaceutical Co., Ltd.
- Email: clinical_trial@ono-pharma.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.