NCT04313335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2023

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

2.2 years

First QC Date

March 7, 2020

Last Update Submit

January 7, 2024

Conditions

Postherpetic Neuralgia

Keywords

Postherpetic Neuralgia, Duloxetine

Outcome Measures

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)

    12 weeks after the reactivation of acute herpes zoster

Secondary Outcomes (4)

  • Averaged weekly VAS score

    up to 12 weeks

  • Averaged weekly analgesic consumption

    up to 12 weeks

  • Patients' overall quality of life

    At the end of Weeks 4, 8, and 12

  • Sleep quality

    At the end of Weeks 4, 8, and 12

Study Arms (2)

Duloxetine

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

DuloxetineDRUG

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.

Duloxetine

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (7)

  • 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.

    PMID: 20434957BACKGROUND

  • 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.

    PMID: 25317872BACKGROUND

  • 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.

    PMID: 29025327BACKGROUND

  • 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.

    PMID: 31166976BACKGROUND

  • 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.

    PMID: 30718068BACKGROUND

  • Zhao C, Zhang T, Zhu Q, Chen Z, Ren H, Shrestha N, Meng L, Shen Y, Luo F. PROCESS Trial: Effect of Duloxetine Premedication for Postherpetic Neuralgia Within 72 Hours of Herpes Zoster Reactivation-A Randomized Controlled Trial. Clin Infect Dis. 2024 Apr 10;78(4):880-888. doi: 10.1093/cid/ciad714.

    PMID: 38015658DERIVED

  • 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.

    PMID: 33298154DERIVED

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

NeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome of the study will be assessed by a third-party organization who will be blinded to the study allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 7, 2020

First Posted

March 18, 2020

Study Start

March 1, 2021

Primary Completion

May 16, 2023

Study Completion

May 16, 2023

Last Updated

January 9, 2024

Record last verified: 2024-01

Locations

CN(1)