Duloxetine for PHN

Prophylactic Duloxetine Administration During Acute Herpes Zoster Prevents Postherpetic Neuralgia

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.

Study Overview

• Status: Completed
• Conditions: Postherpetic Neuralgia
• Intervention / Treatment: Drug: Duloxetine

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 Type: Interventional
• Enrollment (Actual): 750
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
No Intervention: Control; Participants will be given the standard treatment during the acute herpes zoster period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 weeks after the reactivation of acute herpes zoster

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Averaged weekly VAS score	Averaged weekly VAS score of each participant	up to 12 weeks
Averaged weekly analgesic consumption	Averaged weekly consumption per analgesic of each participant	up to 12 weeks
Patients' overall quality of life	12-item Short-Form Health Survey (SF-12)	At the end of Weeks 4, 8, and 12
Sleep quality	Pittsburgh Sleep Quality Index (PSQI) self-rated questionnaire	At the end of Weeks 4, 8, and 12

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Johnson RW, Rice AS. Clinical practice. Postherpetic neuralgia. N Engl J Med. 2014 Oct 16;371(16):1526-33. doi: 10.1056/NEJMcp1403062. No abstract available.
• Drolet M, Brisson M, Schmader K, Levin M, Johnson R, Oxman M, Patrick D, Camden S, Mansi JA. Predictors of postherpetic neuralgia among patients with herpes zoster: a prospective study. J Pain. 2010 Nov;11(11):1211-21. doi: 10.1016/j.jpain.2010.02.020.
• Schutzer-Weissmann J, Farquhar-Smith P. Post-herpetic neuralgia - a review of current management and future directions. Expert Opin Pharmacother. 2017 Nov;18(16):1739-1750. doi: 10.1080/14656566.2017.1392508. Epub 2017 Oct 26.
• Bulilete O, Leiva A, Rullan M, Roca A, Llobera J; PHN Group. Efficacy of gabapentin for the prevention of postherpetic neuralgia in patients with acute herpes zoster: A double blind, randomized controlled trial. PLoS One. 2019 Jun 5;14(6):e0217335. doi: 10.1371/journal.pone.0217335. eCollection 2019.
• Ghanavatian S, Wie CS, Low RS, Zhang N, Montoya JM, Dhaliwal GS, Swanson DL. Premedication With Gabapentin Significantly Reduces the Risk of Postherpetic Neuralgia in Patients With Neuropathy. Mayo Clin Proc. 2019 Mar;94(3):484-489. doi: 10.1016/j.mayocp.2018.11.004. Epub 2019 Feb 2.
• Chen Z, Shrestha N, Zhao C, Fan B, Luo F. Effect of duloxetine premedication for postherpetic neuralgia within 72 h of herpes zoster reactivation [PROCESS]: a study protocol for a randomized controlled trial. Trials. 2020 Dec 9;21(1):1012. doi: 10.1186/s13063-020-04919-6.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): May 16, 2023
• Study Completion (Actual): May 16, 2023

Study Registration Dates

• First Submitted: March 7, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Postherpetic Neuralgia, Duloxetine
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: KY 2020-009-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No