Duloxetine for PHN

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    750
  • sponsor
    Beijing Tiantan Hospital
Updated on 2 April 2021

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.

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.

Details
Condition Postherpetic neuralgia, Postherpetic neuralgia, post-herpetic neuralgia
Treatment Duloxetine
Clinical Study IdentifierNCT04313335
SponsorBeijing Tiantan Hospital
Last Modified on2 April 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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