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Recruiting NCT07361796

The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster

No phase Interventional Herpes Zoster Pain Postherpetic Neuralgia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Venlafaxine combined conventional therapy, Conventional therapy.
Who it may be relevant to
Registry conditions: Herpes Zoster, Pain, Postherpetic Neuralgia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Analgesic Efficacy and Safety of Oral Medications (Venlafaxine) for Prevention of Postherpetic Neuralgia in Acute Herpes Zoster

Overview

Postherpetic neuralgia (PHN) is the most common complication of herpes zoster (HZ) and represents a major clinical challenge due to its chronicity and impact on quality of life. Current treatments for acute HZ pain have limited efficacy in preventing PHN, highlighting the need for effective preventive strategies targeting early pathophysiological mechanisms. Venlafaxine as a plausible and clinically relevant candidate for early intervention to prevent the transition from acute HZ pain to PHN.

Interventions

  • Drug Venlafaxine combined conventional therapy
    Venlafaxine will be initiated at 75 mg once daily and titrated based on pain response and tolerability before 90 days after rash onset. All participants will receive standardized analgesic management following the World Health Organization pain ladder. In addition, the group will contain conventional treatment for HZ, including NSAIDs, opioids, antiviral drugs and so on. After 90 days from rash onset, treatment will be standardized across both groups. Participants who develop persistent pain con
  • Drug Conventional therapy
    The control group will receive conventional therapy alone before 90 days after rash onset. After 90 days from rash onset, treatment will be standardized across both groups. Participants who develop persistent pain consistent with PHN will receive guideline-based management, including gabapentinoids, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, and topical agents such as lidocaine or capsaicin, as clinically indicated.

Primary outcome measures

  • Incidence of PHN [Time frame: at 90 days after rash onset]
Secondary outcome measures (9)
  • The average daily pain intensity [Time frame: at weeks 1, 2, 4, 8, 12, 24, and 52]
  • The worst numeric rating scale score [Time frame: at weeks 1, 2, 4, 8, 12, 24, and 52]
  • Proportion of Patients Achieving Pain Reduction [Time frame: at weeks 1, 2, 4, 8, 12, 24, and 52]
  • Average weekly consumption of each analgesic class [Time frame: at weeks 4, 8, 12, 24, and 52]
  • Herpes Zoster Severity of Illness Index [Time frame: at weeks 1, 2, 4, 8 and 12]
  • The 12-item Short-Form Health Survey (SF-12) score [Time frame: at weeks 4, 8, 12, 24, and 52]
  • The Medical Outcomes Study Sleep Scale (MOS) [Time frame: at weeks 4, 8, 12, 24, and 52]
  • Neuropathic Pain Scale [Time frame: at or after 90 days following rash onset]
  • Adverse events [Time frame: Through study completion, an average of 52 weeks]

Eligibility criteria

Inclusion criteria

  • 1\. Ages more than 18 years;
  • 2\. Patients with onset of HZ rash less than 30 days;
  • 3\. Experiencing moderate to severe HZ pain with an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10 = worst possible pain);
  • 4\. Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
  • 5\. Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;
  • 6\. Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.

Exclusion criteria

  • 1\. HZ with head, neck, ocular, mucous membrane, cranial nerve, or central nervous system involvement or generalized HZ;
  • 2.Known hypersensitivity to venlafaxine;
  • 3.History of major depressive disorder requiring antidepressant therapy;
  • 4.History of systemic immune diseases, organ transplantation, or cancers;
  • 5.Pregnancy or lactation;
  • 6.Presence of acute or chronic pain disorders other than HZ.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijing

Identifiers

NCT: NCT07361796 · KY2025-369-02-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗