A Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia

Last updated: December 20, 2017
Sponsor: ContraVir Pharmaceuticals, Inc.
Overall Status: Terminated

Phase

3

Condition

Shingles

Postherpetic Neuralgia

Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT02412917
CTRV-FV-2-007
  • Ages > 30
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Receive a clinical diagnosis of uncomplicated AHZ as evidenced by a unilateraldermatomal rash

  • Have zoster-related pain

  • Are able to be randomized and receive their first dose within approximately 120 hoursfrom appearance of rash

Exclusion

Exclusion Criteria:

  • Have multidermal or disseminated AHZ

  • Have facial, ophthalmologic or oral manifestations

  • Have received Zostavax

Study Design

Total Participants: 237
Study Start date:
June 01, 2015
Estimated Completion Date:
November 30, 2017

Study 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.

Connect with a study center

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    Birmingham, Alabama
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    Gulf Shores, Alabama
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    Chandler, Arizona
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    Mesa, Arizona
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    Phoenix, Arizona
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    Tempe, Arizona
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    Tuscon, Arizona
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    Fountain Valley, California
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    La Mesa, California
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    Lomita, California
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    Los Angeles, California
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    Martinez, California
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    Oakland, California
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    San Diego, California
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    Tustin, California
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    Vista, California
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    Boulder, Colorado
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    Centennial, Colorado
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    Denver, Colorado
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    Littleton, Colorado
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    Boynton Beach, Florida
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    Doral, Florida
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    Ft. Myers, Florida
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    Largo, Florida
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    Miami, Florida
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    North Miami Beach, Florida
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    Tampa, Florida
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    Perry, Georgia
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    Sandy Springs, Georgia
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    Evansville, Indiana
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    Council Bluffs, Iowa
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    Paducah, Kentucky
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    Eunice, Louisiana
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    New Bedford, Massachusetts
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    Stevensville, Michigan
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    Troy, Michigan
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    Olive Branch, Mississippi
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    Elkhorn, Nebraska
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    Fremont, Nebraska
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    Henderson, Nevada
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    Las Vegas, Nevada
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    Berlin, New Jersey
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    Forrest Hills, New York
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    Hickory, North Carolina
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    North Myrtle Beach, North Carolina
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    Wilmington, North Carolina
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    Fargo, North Dakota
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    Columbus, Ohio
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    Dayton, Ohio
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    Wadsworth, Ohio
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    Edmond, Oklahoma
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    Oklahoma City, Oklahoma
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    Harleysville, Pennsylvania
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    Lansdale, Pennsylvania
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    Anderson, South Carolina
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    Fort Mill, South Carolina
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    Greer, South Carolina
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    Simpsonville, South Carolina
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    Arlington, Texas
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    Baytown, Texas
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    Carrolton, Texas
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    Houston, Texas
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    San Antonio, Texas
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    Sugar Land, Texas
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    Webster, Texas 77598
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    Salt Lake City, Utah
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    Alexandria, Virginia
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    Walla Walla, Washington
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