Herpes Zoster
Conditions
Keywords
Herpes Zoster, Brivudine, pain, treatment
Brief summary
This multicenter RCT aims to compare the efficacy and safety of Brivudine versus Famciclovir in treating acute herpes zoster. Primary objective: Evaluate pain reduction via Numeric Pain Rating Scale (NPRS) at Day 30. Secondary objectives: Compare NPRS at Day 3/Day 7/Day 14/Day 90, time to lesion resolution, Postherpetic Neuralgia (PHN) incidence, and safety.
Detailed description
A randomized controlled trial enrolling 140 participants from 5 centers in China. Patients receive either Brivudine (125mg/day) or Famciclovir (dose-adjusted by creatinine clearance) for 7 days. Follow-ups occur at Day 3, Day 7, Day 14, Day 30, Day 90. Primary endpoint: Numeric Pain Rating Scale (NPRS) at Day 30; secondary endpoints: NPRS at other timepoints, lesion healing time, Postherpetic Neuralgia (PHN) rate, and adverse events.
Interventions
DRUGBrivudine
brivudine 125 mg per dose, once daily, 7 days
DRUGFamciclovir
orally receive famciclovir at doses adjusted based on creatinine clearance (CrCl), 7 days
Sponsors
Peking University First Hospital
Air Force Military Medical University, China
Beijing Hospital of Traditional Chinese Medicine
Xuanwu Hospital, Beijing
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Blinded Investigator conduct the follow-ups.
Intervention model description
Participants receive either Brivudine (125mg/day) or Famciclovir (dose-adjusted by creatinine clearance) for 7 days.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years, regardless of gender; 2. Signed Informed Consent Form; 3. Female subjects must not plan for pregnancy or oocyte donation from screening until 1 week after the last dose and must voluntarily adopt highly effective physical contraception; male subjects must not plan for fertility or sperm donation during the same period and must voluntarily adopt highly effective physical contraception. Methods include: * Barrier methods: Condom or barrier cap (diaphragm or cervical cap); * Intrauterine device (IUD) or intrauterine system (IUS); * Surgical sterilization (bilateral oophorectomy with/without hysterectomy, total hysterectomy, bilateral tubal ligation, or vasectomy) performed ≥6 months prior to the first dose in the subject or their partner; * Other investigator-confirmed highly effective physical contraception.
Exclusion criteria
1. Allergy to brivudine, famciclovir, or penciclovir; 2. Current use of fluorouracil agents (e.g., 5-fluorouracil, capecitabine, tegafur, flucytosine); 3. Cancer patients currently undergoing chemotherapy; 4. Pregnant or lactating women; 5. Parkinson's disease; 6. Any condition deemed inappropriate for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Day 30 numeric pain rating scale (NPRS) | Day 30 | Scores range from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of PHN | Day 90 | Incidence of Postherpetic Neuralgia |
| skin lesion on Day 3, Day 7, Day 14, Day 30, Day 90 | Day 3, Day 7, Day 14, Day 30, Day 90 | whether the presence of hemorrhagic bullae, bullae, erosions, or ulcers |
| Lesion area on Day 3, Day 7, Day 14, Day 30 and Day 90 | Day 3, Day 7, Day 14, Day 30 and Day 90 | Percentage of body surface area (BSA%) affected by lesions on Day 3, Day 7, Day 14, Day 30 and Day 90 |
| numeric pain rating scale (NPRS) on Day 3, Day 7, Day 14, Day 90 | Day 3, Day 7, Day 14, Day 90 | Scores range from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity. |
| complete crusting of all lesions | Day 3, Day 7, Day 14, Day 30 and Day 90 | whether complete crusting of all lesions Day 3, Day 7, Day 14, Day 30 and Day 90 |
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | From baseline to Day 30 | Adverse Events (AEs) and Serious Adverse Events (SAEs) in 30 days |
| cessation of new lesion formation | Day 3, Day 7, Day 14, Day 30 and Day 90 | whether cessation of new papule/vesicle formation on Day 3, Day 7, Day 14, Day 30 and Day 90 |
Countries
China
Contacts
Primary ContactJin-Zhu Guo, M.D.
Outcome results
None listed