A Study of FV-100 Versus Valacyclovir in Patients With Herpes Zoster

Sponsor
Bristol-Myers Squibb
Study ID
NCT00900783
Phase
PHASE2
Status
Completed

Conditions

  • Herpes Zoster
  • Shingles

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • valacyclovir — DRUG
    1 gram, three times a day for seven days
  • FV-100 — DRUG
    400 mg, once daily, for seven days
  • FV-100 — DRUG
    200 mg, once daily, for seven days
  • Valacyclovir placebo — DRUG
    three times a day, for seven days
  • FV-100 placebo — DRUG
    once daily, for seven days

Study Details

The purpose of this study is to compare the safety and efficacy of two doses of FV-100 to valacyclovir in patients with herpes zoster, or shingles. FV-100 has shown to be very potent in cells infected with varicella zoster virus, the virus that causes shingles. The study objectives include: * Compare the safety of FV-100 to valacyclovir * Compare the effect of FV-100, as compared to valacyclovir, on shingles pain * Compare the effect of FV-100, as compared to valacyclovir, on shingles lesions

Key Dates

Start date
May 31, 2009
Status verified
Sep 2015
Primary completion
Nov 30, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
350 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 2
    FV-100, 400 mg once daily AND valacyclovir placebo, three times a day, for seven days
  • Active Comparator: 3
    Valacyclovir, 1 gram, three times a day AND FV-100 placebo, once daily, for seven days
  • Experimental: 1
    FV-100, 200 mg once daily AND valacyclovir placebo, three times a day, for seven days

Primary Outcome Measure

Herpes zoster associated pain, as measured by the Zoster Brief Pain INventory (ZBPI) [ Time Frame: 30 days ]

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