Duloxetine for PHN

Postherpetic Neuralgia Clinical Trial

Official title:

Prophylactic Duloxetine Administration During Acute Herpes Zoster Prevents Postherpetic Neuralgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04313335
• Other study ID #: KY 2020-009-02
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: May 16, 2023

Study information

• Verified date: January 2024
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: May 16, 2023
• Est. primary completion date: May 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (18)

Lead Sponsor

Collaborator

Beijing Tiantan Hospital

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

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

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