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CompletedNCT04313335Updated Jan 9, 2024

Duloxetine for PHN

An interventional study of Duloxetine in Postherpetic Neuralgia, sponsored by Beijing Tiantan Hospital. Completed at 1 site in China. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-01-09.

Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
750
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Postherpetic Neuralgia

Keywords

  • Postherpetic Neuralgia, Duloxetine
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 750 is above the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
750 participants (actual)

Study arms

  • 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

  • No intervention
    Control

    Participants will be given the standard treatment during the acute herpes zoster period.

Interventions

  • DrugDuloxetine

    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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 12 weeks after the reactivation of acute herpes zoster

Secondary outcomes

  1. Averaged weekly VAS score

    Averaged weekly VAS score of each participant

    Time frame: up to 12 weeks

  2. Averaged weekly analgesic consumption

    Averaged weekly consumption per analgesic of each participant

    Time frame: up to 12 weeks

  3. Patients' overall quality of life

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

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

  4. Sleep quality

    Pittsburgh Sleep Quality Index (PSQI) self-rated questionnaire

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

07

Study locations

1 site
  • Beijing Tiantan Hospital
    Beijing, Beijing 100050, China
08

References and documents

Publications

  • 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. PubMed 20434957 ↗
  • 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. PubMed 25317872 ↗
  • 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. PubMed 29025327 ↗
  • 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. PubMed 31166976 ↗
  • 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. PubMed 30718068 ↗
  • 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. PubMed 33298154 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04313335
Lead sponsor
Beijing Tiantan Hospital
Collaborators
China-Japan Friendship Hospital, Tianjin Medical University Second Hospital, Taiyuan Central Hospital of Shanxi Medical University, Linfen Fourth People's Hospital, Shandong Provincial Hospital, Qingdao Municipal Hospital (Group), The Second People's Hospital of Huai'an, First Hospital of China Medical University, Second Affiliated Hospital of Zhengzhou University, Fujian Provincial Hospital, Cangzhou Central Hospital, The People's Hospital of Fujian Province, Beijing Tsinghua Chang Gung Hospital, Peking University International Hospital, Tianjin First Central Hospital, Tianjin Huanhu Hospital, Baoding First Central Hospital
Responsible party
Fang Luo (Professor, Beijing Tiantan Hospital) — Principal investigator
First posted
Mar 18, 2020
Start date
Mar 1, 2021
Primary completion
May 16, 2023
Completion
May 16, 2023
Last update
Jan 9, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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