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Duloxetine for PHN

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ClinicalTrials.gov Identifier: NCT04313335
Recruitment Status : Recruiting
First Posted : March 18, 2020
Last Update Posted : March 24, 2021
Sponsor:
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)
Huai'an Second People's Hospital
First Hospital of China Medical University
The 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
Information provided by (Responsible Party):
Fang Luo, Beijing Tiantan Hospital

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.

Condition or disease Intervention/treatment Phase
Postherpetic Neuralgia Drug: Duloxetine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Primary Purpose: Prevention
Official Title: Prophylactic Duloxetine Administration During Acute Herpes Zoster Prevents Postherpetic Neuralgia
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles
MedlinePlus related topics: Shingles

Arm Intervention/treatment
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
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.

No Intervention: Control
Participants will be given the standard treatment during the acute herpes zoster period.



Primary Outcome Measures :
  1. Preventive efficacy of Postherpetic neuralgia [ Time Frame: 12 weeks after the reactivation of acute herpes zoster ]
    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 :
  1. Averaged weekly VAS score [ Time Frame: up to 12 weeks ]
    Averaged weekly VAS score of each participant

  2. Averaged weekly analgesic consumption [ Time Frame: up to 12 weeks ]
    Averaged weekly consumption per analgesic of each participant

  3. Patients' overall quality of life [ Time Frame: At the end of Weeks 4, 8, and 12 ]
    12-item Short-Form Health Survey (SF-12)

  4. Sleep quality [ Time Frame: At the end of Weeks 4, 8, and 12 ]
    Pittsburgh Sleep Quality Index (PSQI) self-rated questionnaire



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04313335


Contacts
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Contact: Fang Luo, M.D. +86 13611326978 13611326978@163.com

Locations
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China, Beijing
Beijing Tiantan Hospital Recruiting
Beijing, Beijing, China, 100050
Contact: Fang Luo, M.D.    +86 13611326978    13211326978@163.com   
Principal Investigator: Fang Luo, M.D.         
Sponsors and Collaborators
Beijing Tiantan Hospital
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)
Huai'an Second People's Hospital
First Hospital of China Medical University
The 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
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fang Luo, Professor, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT04313335    
Other Study ID Numbers: KY 2020-009-02
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fang Luo, Beijing Tiantan Hospital:
Postherpetic Neuralgia, Duloxetine
Additional relevant MeSH terms:
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Neuralgia
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents