A Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia
Primary Purpose
Shingles, Herpes Zoster, Postherpetic Neuralgia
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
FV-100
valacyclovir
Sponsored by
About this trial
This is an interventional prevention trial for Shingles
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
Sites / Locations
- TX
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
FV-100 400 mg QD
FV-100 400mg BID
valacyclovir
Arm Description
FV-100 400mg QD
FV-100 400mg BID(total daily dose of 800mg)
valacyclovir 1000mg TID
Outcomes
Primary Outcome Measures
The incidence of post-herpetic neuralgia(PHN) following treatment with 2 dose regimens of FV-100 compared to valacyclovir.
efficacy measure
Secondary Outcome Measures
Acute herpes zoster associated pain, as measured by Zoster Brief Pain Inventory(ZBPI)
efficacy measure
The effect on lesion formation and healing of 2 dose regimens of FV-100 compared to valacyclovir
efficacy measure
The number and classification of adverse events in 2 dosing regimens of FV-100
Safety measure
The pharmacokinetic profile of the active metabolite of FV-100 after 7 days of dosing at 400mg QD versus compared with 400mg BID
Pharmacokinetic
Full Information
NCT ID
NCT02412917
First Posted
March 23, 2015
Last Updated
December 20, 2017
Sponsor
ContraVir Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02412917
Brief Title
A Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Study Start Date
June 2015 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ContraVir Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shingles, Herpes Zoster, Postherpetic Neuralgia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
237 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FV-100 400 mg QD
Arm Type
Experimental
Arm Description
FV-100 400mg QD
Arm Title
FV-100 400mg BID
Arm Type
Experimental
Arm Description
FV-100 400mg BID(total daily dose of 800mg)
Arm Title
valacyclovir
Arm Type
Active Comparator
Arm Description
valacyclovir 1000mg TID
Intervention Type
Drug
Intervention Name(s)
FV-100
Other Intervention Name(s)
antiviral nucleoside analog
Intervention Description
antiviral nucleoside analog
Intervention Type
Drug
Intervention Name(s)
valacyclovir
Other Intervention Name(s)
valtrex
Intervention Description
antiviral nucleoside analog
Primary Outcome Measure Information:
Title
The incidence of post-herpetic neuralgia(PHN) following treatment with 2 dose regimens of FV-100 compared to valacyclovir.
Description
efficacy measure
Time Frame
Day 1 to Day 120
Secondary Outcome Measure Information:
Title
Acute herpes zoster associated pain, as measured by Zoster Brief Pain Inventory(ZBPI)
Description
efficacy measure
Time Frame
Day 1 to Day 120
Title
The effect on lesion formation and healing of 2 dose regimens of FV-100 compared to valacyclovir
Description
efficacy measure
Time Frame
Day 1 to Day 120
Title
The number and classification of adverse events in 2 dosing regimens of FV-100
Description
Safety measure
Time Frame
Day 1 to Day 120
Title
The pharmacokinetic profile of the active metabolite of FV-100 after 7 days of dosing at 400mg QD versus compared with 400mg BID
Description
Pharmacokinetic
Time Frame
Day 1 to Day 120
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Sullivan-Bolyai
Organizational Affiliation
CMO
Official's Role
Study Director
Facility Information:
Facility Name
TX
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia
We'll reach out to this number within 24 hrs