A Phase 2b Trial of EPB-348 for the Treatment of Herpes Zoster
Part of paid clinical trials in Houston, Texas.
- Sponsor
- Epiphany Biosciences
- Study ID
- NCT00831103
- Phase
- PHASE2
- Status
- Completed
Conditions
- Herpes Zoster
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- EPB-348 — DRUGTreated over seven days
- Valacyclovir — DRUGTreated over seven days
Study Details
The purpose of this study is to determine the pharmacokinetics and dosage of EPB-348 that best balances safety and efficacy among adult immunocompetent patients with an acute episode of herpes zoster.
Key Dates
- Start date
- Nov 30, 2007
- Status verified
- Dec 2013
- Primary completion
- Jun 30, 2009
- Completion
- Jun 30, 2009
Study Design
- Enrollment
- 373 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: EPB-348 1000 mgEPB-348 1000 mg dosed once daily for seven days
- Experimental: EPB-348 2000 mgEPB-348 2000 mg dosed once daily for seven days
- Experimental: EPB-348 3000 mgEPB-348 3000 mg dosed once daily for seven days
- Active Comparator: ValacyclovirValacyclovir 1000 mg dosed three times daily for seven days
Primary Outcome Measure
To compare the time-to-crusting of vesicles on patients in each of the EPB-348 dosing arms versus the valacyclovir dosing arm. [ Time Frame: Daily assessment during the seven days of treament then weekly until Day 28 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Center for Clinical Studies-Medical Center | Houston | Texas | 77030 | - |
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