Postherpetic Neuralgia
Conditions
Keywords
Postherpetic Neuralgia, Duloxetine
Brief summary
In this study, the investigators aim to investigate the preventive efficacy of prophylactic oral duloxetine during acute herpes zoster on postherpetic neuralgia and its safety.
Detailed description
Postherpetic neuralgia is a common complication of herpes zoster. Several interventions have been investigated for the treatment of postherpetic neuralgia, however, there is a lack of preventive intervention on postherpetic neuralgia. A recent retrospective study revealed that the administration of gabapentin during the acute herpes zoster period significantly decreased the incidence of postherpetic neuralgia. In the present study, the investigators aim to conduct a prospective, randomized, open-label, endpoint blinded study to investigate the preventive efficacy of prophylactic use of duloxetine on postherpetic neuralgia.
Interventions
DRUGDuloxetine
Oral Duloxetine (up to 60 mg per day) will be given, titrated, tapered in accordance with the pain intensity during the acute herpes zoster period.
Sponsors
China-Japan Friendship Hospital
Tianjin Medical University Second Hospital
Taiyuan Central Hospital of Shanxi Medical University
Linfen Fourth People's Hospital
Shandong Provincial Hospital
Qingdao Municipal Hospital (Group)
The Second People's Hospital of Huai'an
First Hospital of China Medical University
Second Affiliated Hospital of Zhengzhou University
Fujian Provincial Hospital
Cangzhou Central Hospital
The People's Hospital of Fujian Province
Beijing Tsinghua Chang Gung Hospital
Peking University International Hospital
Tianjin First Central Hospital
Tianjin Huanhu Hospital
Baoding First Central Hospital
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome of the study will be assessed by a third-party organization who will be blinded to the study allocation.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ages more than 50 years; * diagnosed with uncomplicated acute herpes zoster; * presents with vesicles within 72 hours; * has an average pain score of at least 40/100 mm on a visual analog scale (VAS, 0 = no pain, 100 = worst possible pain, at opposite ends of a 100-mm line).
Exclusion criteria
* refuses to participate or to provide written informed consent; * Zung Self-Rating Depression Scale raw score of more than 50 points; * herpes zoster that involves with head, neck, ocular, mucous membrane, cranial nerve, or central nervous system; * has hemorrhagic or necrotizing lesions, satellite lesions, abnormal vesicles or acute retinal necrosis; * has been on immunosuppressive therapy or mono- or multi-pharmacotherapy that involves any tricyclic antidepressant, valacyclovir, duloxetine or cytotoxic medications before acute HZ onset; * has been diagnosed with hepatic, renal or immune dysfunction; * during pregnancy or breastfeeding at the time; * hypersensitivity to the study drugs; * has contraindications to valacyclovir or duloxetine; * HZ vaccinated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preventive efficacy of Postherpetic neuralgia | 12 weeks after the reactivation of acute herpes zoster | The proportion of participants in the Interventional Arm who gain a 0 score in a 100 mm visual analgue scale (0 mm = no pain, 100 mm = the most imaginable pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Averaged weekly VAS score | up to 12 weeks | Averaged weekly VAS score of each participant |
| Averaged weekly analgesic consumption | up to 12 weeks | Averaged weekly consumption per analgesic of each participant |
| Patients' overall quality of life | At the end of Weeks 4, 8, and 12 | 12-item Short-Form Health Survey (SF-12) |
| Sleep quality | At the end of Weeks 4, 8, and 12 | Pittsburgh Sleep Quality Index (PSQI) self-rated questionnaire |
Countries
China
Outcome results
None listed