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Duloxetine for PHN

Primary Purpose

Postherpetic Neuralgia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Duloxetine
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postherpetic Neuralgia focused on measuring Postherpetic Neuralgia, Duloxetine

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Tiantan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Duloxetine

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Averaged weekly VAS score
Averaged weekly VAS score of each participant
Averaged weekly analgesic consumption
Averaged weekly consumption per analgesic of each participant
Patients' overall quality of life
12-item Short-Form Health Survey (SF-12)
Sleep quality
Pittsburgh Sleep Quality Index (PSQI) self-rated questionnaire

Full Information

First Posted
March 7, 2020
Last Updated
March 21, 2021
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
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1. Study Identification

Unique Protocol Identification Number
NCT04313335
Brief Title
Duloxetine for PHN
Official Title
Prophylactic Duloxetine Administration During Acute Herpes Zoster Prevents Postherpetic Neuralgia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia
Keywords
Postherpetic Neuralgia, Duloxetine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcome of the study will be assessed by a third-party organization who will be blinded to the study allocation.
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Duloxetine
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will be given the standard treatment during the acute herpes zoster period.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preventive efficacy of Postherpetic neuralgia
Description
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 Outcome Measure Information:
Title
Averaged weekly VAS score
Description
Averaged weekly VAS score of each participant
Time Frame
up to 12 weeks
Title
Averaged weekly analgesic consumption
Description
Averaged weekly consumption per analgesic of each participant
Time Frame
up to 12 weeks
Title
Patients' overall quality of life
Description
12-item Short-Form Health Survey (SF-12)
Time Frame
At the end of Weeks 4, 8, and 12
Title
Sleep quality
Description
Pittsburgh Sleep Quality Index (PSQI) self-rated questionnaire
Time Frame
At the end of Weeks 4, 8, and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Luo, M.D.
Phone
+86 13611326978
Email
13611326978@163.com
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Luo, M.D.
Phone
+86 13611326978
Email
13211326978@163.com
First Name & Middle Initial & Last Name & Degree
Fang Luo, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20434957
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.
Results Reference
background
PubMed Identifier
25317872
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.
Results Reference
background
PubMed Identifier
29025327
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.
Results Reference
background
PubMed Identifier
31166976
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.
Results Reference
background
PubMed Identifier
30718068
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.
Results Reference
background
PubMed Identifier
33298154
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.
Results Reference
derived

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Duloxetine for PHN

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