Duloxetine for PHN

Not Applicable

Completed

• Conditions: Postherpetic Neuralgia
• Interventions: Drug: Duloxetine

• Registration Number: NCT04313335
• Lead Sponsor: Beijing Tiantan Hospital

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.

Study Timeline

• Study First Submitted: 2020-03-07
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-18
• Study Start: 2021-03-01
• Primary Completion: 2023-05-16
• Study Completion: 2023-05-16
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-07
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Duloxetine	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China