The Analgesic Efficacy and Safety of Oral Medications (Desvenlafaxine) in Patients With Herpes Zoster
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 750
- Locations
- 1
- Primary Endpoint
- the average numeric rating scale score over the past 24 hours, rated each morning upon awakening and average over 7 days.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
- •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. 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;
- •5. Pregnancy or breastfeeding;
- •6. Suffering from acute or chronic pain disorders other than HZ.
Arms & Interventions
Desvenlafaxine combined with conventional therapy group
Intervention: Desvenlafaxine combined conventional therapy (Drug)
Conventional therapy group
Intervention: Conventional therapy (Drug)
Outcomes
Primary Outcomes
the average numeric rating scale score over the past 24 hours, rated each morning upon awakening and average over 7 days.
Time Frame: At week 4 after experimental drug medication
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.
Secondary Outcomes
- The worst numeric rating scale score(at weeks 1, 2, 4, 8, and 12 after experimental drug medication)
- Proportion of Patients Achieving Pain Reduction(at weeks 1, 2, 4, 8, and 12 after experimental drug medication)
- Proportion of patients developing postherpetic neuralgia(at week 12 after experimental drug medication)
- The type of analgesics and average weekly consumption per analgesics(at weeks 4, 8, and 12 after experimental drug medication)
- The 12-item Short-Form Health Survey (SF-12) score(at weeks 4, 8, and 12 after experimental drug medication)
- The Medical Outcomes Study Sleep Scale (MOS)(at weeks 4, 8, and 12 after experimental drug medication)
- Adverse events(Through study completion, an average of 12 weeks)
Investigators
Fang Luo
Director, Department of Pain Management, Principal Investigator, Clinical Professor
Beijing Tiantan Hospital