Esketamine with Pregabalin and Duloxetine for Pain Relief in Postherpetic Neuralgia
Intravenous Infusion of Esketamine in Combination With Pregabalin and Duloxetine for Postherpetic Neuralgia
This study is testing if combining esketamine with pregabalin and duloxetine can help people with postherpetic neuralgia find faster and better pain relief when pregabalin alone hasn’t worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06896994 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects and safety of esketamine when combined with pregabalin and duloxetine in patients suffering from postherpetic neuralgia (PHN). The goal is to determine if this combination can provide rapid and effective pain relief for patients who have not responded to pregabalin alone. Participants will be monitored over a one-week period to assess pain reduction and any potential side effects. The study aims to offer a new treatment option for those with refractory PHN.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with persistent pain from postherpetic neuralgia lasting more than three months and who have not adequately responded to pregabalin.
Not a fit: Patients with certain medical conditions, such as severe cardiopulmonary issues or a history of drug abuse, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate pain for patients suffering from postherpetic neuralgia.
How similar studies have performed: While the combination of these specific treatments is being explored in this study, similar approaches have shown promise in managing chronic pain conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ages more than 18 years; 2. Pain present for more than 3 months after healing of a herpes zoster skin rash; 3. Has an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0= no pain, 10= worst possible pain)； 4. Failed to respond to or tolerate the effective dose of pregabalin monotherapy. Exclusion Criteria: 1. Obstructive sleep apnoea syndrome; 2. Those who receive interventional treatments; 3. A history of systemic immune diseases, organ transplantation, or cancers; 4. A history of severe cardiopulmonary, hepatic or renal dysfunction; 5. A history of schizophrenia, epilepsy, or myasthenia gravis, delirium; 6. Currently using monoamine oxidase inhibitors (MAOIs); 7. Having untreated angle-closure glaucoma; 8. Those suffering from increased intracranial pressure； 9. Comorbid hyperthyroidism or phaeochromocytoma; 10. Suspected or confirmed history of drug abuse; 11. Having contraindications to esketamine, pregabaline or duloxetine; 12. Communication difficulties; 13. Women who are preparing for pregnancy, in the pregnancy or lactation period.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Fang Luo, M.D. — Beijing Tiantan Hospital
- Study coordinator: Fang Luo, M.D.
- Email: 13611326978@163.com
- Phone: +86 13611326978
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.