Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster
ConditionHerpes Zoster
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University Third Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years, regardless of gender;
Signed Informed Consent Form;
Barrier methods: Condom or barrier cap (diaphragm or cervical cap);
Intrauterine device (IUD) or intrauterine system (IUS);
Disqualifiers
Allergy to brivudine, famciclovir, or penciclovir;
Current use of fluorouracil agents (e.g., 5-fluorouracil, capecitabine, tegafur, flucytosine);
Cancer patients currently undergoing chemotherapy;
Pregnant or lactating women;
Trial design
Design model
Parallel
Treatments tested in this trial
Brivudine
Drugbrivudine 125 mg per dose, once daily, 7 days
Famciclovir
Drugorally receive famciclovir at doses adjusted based on creatinine clearance (CrCl), 7 days
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Brivudine GroupExperimental treatment 1 intervention
Group B: Famciclovir GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 30Secondary outcomes
1
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.
Time frame
Day 3, Day 7, Day 14, Day 902
Incidence of PHN
Incidence of Postherpetic Neuralgia
Time frame
Day 903
skin lesion on Day 3, Day 7, Day 14, Day 30, Day 90
whether the presence of hemorrhagic bullae, bullae, erosions, or ulcers
Time frame
Day 3, Day 7, Day 14, Day 30, Day 904
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
Time frame
Day 3, Day 7, Day 14, Day 30 and Day 90Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University Third Hospital
Lead sponsor
Peking University First Hospital
Collaborator
Air Force Military Medical University, China
Collaborator
Beijing Hospital of Traditional Chinese Medicine
Collaborator
Xuanwu Hospital, Beijing
Collaborator
Source ClinicalTrials.gov