Duloxetine for PHN

Beijing Tiantan Hospital750 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

750

Conditions

Postherpetic Neuralgia

Interventions

DuloxetineDRUG

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.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Preventive efficacy of Postherpetic neuralgia

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)

Time frame: 12 weeks after the reactivation of acute herpes zoster

Secondary Outcomes

Averaged weekly VAS score

Averaged weekly VAS score of each participant

Time frame: up to 12 weeks

Averaged weekly analgesic consumption

Averaged weekly consumption per analgesic of each participant

Time frame: up to 12 weeks

Patients' overall quality of life

12-item Short-Form Health Survey (SF-12)

Time frame: At the end of Weeks 4, 8, and 12

Sleep quality

Pittsburgh Sleep Quality Index (PSQI) self-rated questionnaire

Time frame: At the end of Weeks 4, 8, and 12

Data from ClinicalTrials.gov

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