Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00900783 | A Study of FV-100 Versus Valacyclovir in Patients With Herpes Zoster | PHASE2 | COMPLETED | 350 | — | — | May 1, 2009 | Dec 1, 2010 | Oct 12, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| 2 | EXPERIMENTAL | FV-100, 400 mg once daily AND valacyclovir placebo, three times a day, for seven days |
| 3 | ACTIVE_COMPARATOR | Valacyclovir, 1 gram, three times a day AND FV-100 placebo, once daily, for seven days |
| 1 | EXPERIMENTAL | FV-100, 200 mg once daily AND valacyclovir placebo, three times a day, for seven days |
| Name | Type | Description |
|---|---|---|
| valacyclovir | DRUG | 1 gram, three times a day for seven days |
| FV-100 | DRUG | 400 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 |
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...