A Multicenter, Randomized, Double-Blind, Parallel-Group, Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia and Treatment of Acute Herpes Zoster Associated Pain
Overview
- Phase
- Phase 3
- Intervention
- FV-100
- Conditions
- Shingles
- Sponsor
- ContraVir Pharmaceuticals, Inc.
- Enrollment
- 237
- Locations
- 1
- Primary Endpoint
- The incidence of post-herpetic neuralgia(PHN) following treatment with 2 dose regimens of FV-100 compared to valacyclovir.
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
This is a multicenter, randomized, double-blind, parallel-group, active controlled comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster).
Detailed Description
This is a multicenter, randomized, double-blind, parallel-group, active controlled comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster). Subjects diagnosed with uncomplicated AHZ within 72 hours of lesion appearance and worst pain of 4 or greater at day 1, will be randomized (1:1:1) to one of three treatment groups and will begin study treatment at the Day 1 visit(within 72 hours of AHZ lesion appearance) to either: 1. FV-100 400mg QD, 2. FV-100 400mg BID(total daily dose of 800mg), or 3. Valacyclovir 1000mg 3 times a day for a total daily dose of 3000mg. Subjects will be monitored for adverse events through day 21. Efficacy assessments for lesion status and AHZ pain are captured til day 120.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Receive a clinical diagnosis of uncomplicated AHZ as evidenced by a unilateral dermatomal rash
- •Have zoster-related pain
- •Are able to be randomized and receive their first dose within approximately 120 hours from appearance of rash
Exclusion Criteria
- •Have multidermal or disseminated AHZ
- •Have facial, ophthalmologic or oral manifestations
- •Have received Zostavax
Arms & Interventions
FV-100 400 mg QD
FV-100 400mg QD
Intervention: FV-100
FV-100 400mg BID
FV-100 400mg BID(total daily dose of 800mg)
Intervention: FV-100
valacyclovir
valacyclovir 1000mg TID
Intervention: valacyclovir
Outcomes
Primary Outcomes
The incidence of post-herpetic neuralgia(PHN) following treatment with 2 dose regimens of FV-100 compared to valacyclovir.
Time Frame: Day 1 to Day 120
efficacy measure
Secondary Outcomes
- Acute herpes zoster associated pain, as measured by Zoster Brief Pain Inventory(ZBPI)(Day 1 to Day 120)
- The number and classification of adverse events in 2 dosing regimens of FV-100(Day 1 to Day 120)
- The pharmacokinetic profile of the active metabolite of FV-100 after 7 days of dosing at 400mg QD versus compared with 400mg BID(Day 1 to Day 120)
- The effect on lesion formation and healing of 2 dose regimens of FV-100 compared to valacyclovir(Day 1 to Day 120)