Skip to main content
OpenTrials
Completed

NCT Number: NCT04313335

Duloxetine for PHN

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Duloxetine

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.

Primary outcomes

  1. Preventive efficacy of Postherpetic neuralgia

    Time frame: 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 outcomes

  1. Averaged weekly VAS score

    Time frame: up to 12 weeks

    Averaged weekly VAS score of each participant

  2. Averaged weekly analgesic consumption

    Time frame: up to 12 weeks

    Averaged weekly consumption per analgesic of each participant

  3. Patients' overall quality of life

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

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

  4. Sleep quality

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

    Pittsburgh Sleep Quality Index (PSQI) self-rated questionnaire

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Baoding First Central Hospital
  • Beijing Tsinghua Chang Gung Hospital
  • Cangzhou Central Hospital
  • China-Japan Friendship Hospital
  • First Hospital of China Medical University
  • Fujian Provincial Hospital
  • Linfen Fourth People's Hospital
  • Peking University International Hospital
  • Qingdao Municipal Hospital (Group)
  • Second Affiliated Hospital of Zhengzhou University
  • Shandong Provincial Hospital
  • Taiyuan Central Hospital of Shanxi Medical University
  • The People's Hospital of Fujian Province
  • The Second People's Hospital of Huai'an
  • Tianjin First Central Hospital
  • Tianjin Huanhu Hospital
  • Tianjin Medical University Second Hospital

Registry information

Official study title

Prophylactic Duloxetine Administration During Acute Herpes Zoster Prevents Postherpetic Neuralgia

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 18, 2020
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.