Duloxetine for PHN

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-05-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postherpetic Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

The outcome of the study will be assessed by a third-party organization who will be blinded to the study allocation.

Study Groups

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Duloxetine

Apart from the standard treatment, participants in the Duloxetine Arm will be administered with oral duloxetine (up to 60 mg per day) in the acute herpes zoster period.

Group Type EXPERIMENTAL

Duloxetine

Intervention Type DRUG

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.

Control

Participants will be given the standard treatment during the acute herpes zoster period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Duloxetine

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No