The Analgesic Efficacy and Safety of Desvenlafaxine in Patients With Herpes Zoster

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital

About this trial

Herpes zoster (HZ) is characterized by a painful dermatomal rash and significantly affects quality of life, with acute pain increasing the risk of postherpetic neuralgia. Although early antiviral therapy limits viral replication, its analgesic effect is insufficient, and many patients experience inadequate relief despite stepwise use of non-opioids and opioids. Recent attention has focused on the potential role of antidepressants, which have central antinociceptive property and may offer analgesic benefits by modulating central nervous system pain pathways through increased serotonin and norepinephrine availability. Therefore, investigators hypothesize that desvenlafaxine may effectively reduce the severity of HZ pain without significantly increasing adverse events.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Ages more than 18 years;

2. Patients with onset of HZ rash less than 90 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;

Disqualifiers

1. History of taking desvenlafaxine;

2. Patients with evidence of cutaneous or visceral dissemination of HZ infection (cutaneous dissemination is defined as more than 20 discrete lesions outside adjacent dermatomes) or ocular involvement of HZ;

3. History of intolerance or hypersensitivity to any active components or excipient of the desvenlafaxine;

4. History of systemic immune diseases, organ transplantation, or cancers;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Desvenlafaxine combined conventional therapy

    Drug

    In the desvenlafaxine combined conventional therapy group, venlafaxine will be initiated at 50 mg daily. The maximum recommended dose is 400 mg daily. In addition, the group will contain conventional treatment for HZ, except desvenlafaxine, including NSAIDs, opioids, antiviral drugs and so on.

  • Conventional therapy

    Drug

    In the conventional therapy group, treatments will include NSAIDs, opioids, antiviral drugs and so on.

Treatment groups

750 Participants
are divided into 2 treatment groups
Group A: Desvenlafaxine combined with conventional therapy groupExperimental treatment 1 intervention
Group B: Conventional therapy groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

the average numeric rating scale score over the past 24 hours, rated each morning upon awakening and average over 7 days.

The numeric rating scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain. A higher score indicates more severe pain.

Time frame
At week 4 after experimental drug medication

Secondary outcomes

1

The worst numeric rating scale score

The numeric rating scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain. A higher score indicates more severe pain.

Time frame
at weeks 1, 2, 4, 8, and 12 after experimental drug medication
2

Proportion of Patients Achieving Pain Reduction

The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity

Time frame
at weeks 1, 2, 4, 8, and 12 after experimental drug medication
3

Proportion of patients developing postherpetic neuralgia

Time frame
at week 12 after experimental drug medication
4

The type of analgesics and average weekly consumption per analgesics

Time frame
at weeks 4, 8, and 12 after experimental drug medication

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.