Clinical trial NCT04313335: Duloxetine for PHN
Official title: Prophylactic Duloxetine Administration During Acute Herpes Zoster Prevents Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postherpetic Neuralgia
Keywords: Postherpetic Neuralgia, Duloxetine
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: China-Japan Friendship Hospital
name: Tianjin Medical University Second Hospital
name: Taiyuan Central Hospital of Shanxi Medical University
name: Linfen Fourth People's Hospital
name: Shandong Provincial Hospital
name: Qingdao Municipal Hospital (Group)
name: The Second People's Hospital of Huai'an
name: First Hospital of China Medical University
name: Second Affiliated Hospital of Zhengzhou University
name: Fujian Provincial Hospital
name: Cangzhou Central Hospital
name: The People's Hospital of Fujian Province
name: Beijing Tsinghua Chang Gung Hospital
name: Peking University International Hospital
name: Tianjin First Central Hospital
name: Tianjin Huanhu Hospital
name: Baoding First Central Hospital
First posted: 2020-03-18
Enrollment: 750
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Preventive efficacy of Postherpetic neuralgia
timeFrame: 12 weeks after the reactivation of acute herpes zoster
Secondary outcomes:
measure: Averaged weekly VAS score
timeFrame: up to 12 weeks
measure: Averaged weekly analgesic consumption
timeFrame: up to 12 weeks
measure: Patients' overall quality of life
timeFrame: At the end of Weeks 4, 8, and 12
measure: Sleep quality
timeFrame: At the end of Weeks 4, 8, and 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.