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FV-100 vs Valacyclovir in Herpes Zoster
NCT00900783Phase 2
Key facts
- Status
- Completed
- Start
- May 2009
- Primary completion
- Nov 2010
- Sponsor
- Bristol Myers Squibb
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Conditions
- herpes zoster (HZ)
01
Overview
Phase 2, randomised, double-blind trial of n-methanocarbathymidine in herpes zoster (HZ) (3 arms), sponsored by Bristol Myers Squibb. Primary endpoint: Zoster Brief Pain Inventory at 30 days. Started May 2009; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
FV-100 200 mg
FV-100 200 mg QD + Valacyclovir placebo
FV-100 400 mg
FV-100 400 mg QD + Valacyclovir placebo
Valacyclovir 1 g
Valacyclovir 1 g TID + FV-100 placebo
03
Who it enrols
Patients >= 50 years with acute herpes zoster (shingles) and pain, presenting within 72 hours of rash onset.
04
Endpoints
Primary
Zoster Brief Pain Inventory
Secondary
Zoster Brief Pain Inventory
Herpes zoster lesion healing
Routine clinical labs
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