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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Air Force Military Medical University, China | OTHER |
| Beijing Hospital of Traditional Chinese Medicine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brivudine Group | Experimental |
| |
| Famciclovir Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brivudine | Drug | brivudine 125 mg per dose, once daily, 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Day 30 numeric pain rating scale (NPRS) | Scores range from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| numeric pain rating scale (NPRS) on 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. | Day 3, Day 7, Day 14, Day 90 |
| Incidence of PHN |
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Inclusion Criteria:
Age ≥18 years, regardless of gender;
Signed Informed Consent Form;
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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin-Zhu Guo, M.D. | Contact | 008613521115717 | guojinzhu_826@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | 100191 | China |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C020235 | brivudine |
| D000077595 | Famciclovir |
| ID | Term |
|---|---|
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Xuanwu Hospital, Beijing |
| OTHER |
Participants receive either Brivudine (125mg/day) or Famciclovir (dose-adjusted by creatinine clearance) for 7 days.
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Blinded Investigator conduct the follow-ups.
| Famciclovir |
| Drug |
orally receive famciclovir at doses adjusted based on creatinine clearance (CrCl), 7 days |
|
Incidence of Postherpetic Neuralgia |
| Day 90 |
| skin lesion on Day 3, Day 7, Day 14, Day 30, Day 90 | whether the presence of hemorrhagic bullae, bullae, erosions, or ulcers | Day 3, Day 7, Day 14, Day 30, Day 90 |
| Lesion area on 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 | Day 3, Day 7, Day 14, Day 30 and Day 90 |
| cessation of new lesion formation | whether cessation of new papule/vesicle formation on Day 3, Day 7, Day 14, Day 30 and Day 90 | Day 3, Day 7, Day 14, Day 30 and Day 90 |
| complete crusting of all lesions | whether complete crusting of all lesions Day 3, Day 7, Day 14, Day 30 and Day 90 | Day 3, Day 7, Day 14, Day 30 and Day 90 |
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse Events (AEs) and Serious Adverse Events (SAEs) in 30 days | From baseline to Day 30 |
| Beijing Hospital of Traditional Chinese Medicine, Capital Medical University | Recruiting | Beijing | China |
|
| Peking University First Hospital | Recruiting | Beijing | China |
|
| Xuanwu Hospital, Capital Medical University | Not yet recruiting | Beijing | China |
|
| D007239 | Infections |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |