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FV-100

Phase 2

Herpes Zoster | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Oct 12, 2015

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment350

FDA Designations

No designations recorded

Clinical trial landscape

FV-100 · 1 trial · 2 indications

Phase 2 1
NCT00900783A Study of FV-100 Versus Valacyclovir in Patients With Herpes ZosterHerpes Zoster
COMPLETED350 Analytics
PHASE2COMPLETED
A Study of FV-100 Versus Valacyclovir in Patients With Herpes Zoster
Herpes ZosterUnlock trial analytics

Study Endpoints

Primary Endpoints

Herpes zoster associated pain, as measured by the Zoster Brief Pain INventory (ZBPI)
30 days

Secondary Endpoints

Herpes zoster associated pain
90 days
Herpes zoster lesion healing
Until healed
Routine clinical labs
30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
2EXPERIMENTALFV-100, 400 mg once daily AND valacyclovir placebo, three times a day, for seven days
3ACTIVE_COMPARATORValacyclovir, 1 gram, three times a day AND FV-100 placebo, once daily, for seven days
1EXPERIMENTALFV-100, 200 mg once daily AND valacyclovir placebo, three times a day, for seven days

Interventions

NameTypeDescription
valacyclovirDRUG1 gram, three times a day for seven days
FV-100DRUG400 mg, once daily, for seven days
Valacyclovir placeboDRUGthree times a day, for seven days
FV-100 placeboDRUGonce daily, for seven days
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Men and women ≥ 50 years of age * Patients with a clinical diagnosis of HZ as evidenced by a unilateral dermatomal rash * Patients with zoster-related pain (ZBPI worst pain score \> 0) * Patients able to be enrolled into the study ≤ 72 hours from appearance of rash (i.e., lesi...

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