NCT00831103

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
373

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

December 5, 2013

Status Verified

December 1, 2013

Enrollment Period

1.6 years

First QC Date

January 26, 2009

Last Update Submit

December 3, 2013

Conditions

Herpes Zoster

Keywords

EPB348Valomaciclovir StearateValacyclovirHerpes ZosterShingles

Outcome Measures

Primary Outcomes (1)

  • To compare the time-to-crusting of vesicles on patients in each of the EPB-348 dosing arms versus the valacyclovir dosing arm.

    Daily assessment during the seven days of treament then weekly until Day 28

Study Arms (4)

EPB-348 1000 mg

EXPERIMENTAL

EPB-348 1000 mg dosed once daily for seven days

Drug: EPB-348

EPB-348 2000 mg

EXPERIMENTAL

EPB-348 2000 mg dosed once daily for seven days

Drug: EPB-348

EPB-348 3000 mg

EXPERIMENTAL

EPB-348 3000 mg dosed once daily for seven days

Drug: EPB-348

Valacyclovir

ACTIVE COMPARATOR

Valacyclovir 1000 mg dosed three times daily for seven days

Drug: Valacyclovir

Interventions

EPB-348DRUG

Treated over seven days

Also known as: Valomaciclovir Stearate
EPB-348 1000 mgEPB-348 2000 mgEPB-348 3000 mg
ValacyclovirDRUG

Treated over seven days

Also known as: Valtrex
Valacyclovir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female adults at least 18 years of age
  • Patients with signs and symptoms consistent with acute herpes zoster disease, namely, a dermatomal vesicular rash which may be preceded by pain and parasthesias in the days before vesicular eruption
  • Herpes Zoster associated rash present for ≤ 72 hours
  • Patients who are deemed to be immunocompetent based on history and physical exam

You may not qualify if:

  • Females who are pregnant or nursing
  • History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic, or unstable heart disease, gastrointestinal, neurological, psychiatric, renal, urological, endocrine, opthalmologic, or immune mediated disease including HIV or HBsAg positivity
  • Chronic genital herpes
  • Patients who received cytotoxic or immunosuppressive drug therapy within 3 months prior to study participation
  • Previous vaccinations against Herpes Zoster
  • Patients with \> 50% of vesicles crusted at screen
  • Patients who received topical or systemic antiviral medications or immunomodulatory agents for herpes zoster viral infections or capsaicin within 4 weeks of study participation
  • Patients with a history of congenital, acquired, or corticosteroid induced immunodeficiency, including malignancy, significantly impaired renal function (creatinine clearance \< 50 cc/min), and impaired hepatic function (ALT or AST levels \> 3 times the upper limit of normal)
  • QTc \> 500msec
  • Patients with a history of intolerance or hypersensitivity to acyclovir, penciclovir, valacyclovir, or famciclovir
  • Patients with gastrointestinal dysfunction that might interfere with drug absorption
  • Patients, considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Clinical Studies-Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Tyring SK, Plunkett S, Scribner AR, Broker RE, Herrod JN, Handke LT, Wise JM, Martin PA; Valomaciclovir Zoster Study Group. Valomaciclovir versus valacyclovir for the treatment of acute herpes zoster in immunocompetent adults: a randomized, double-blind, active-controlled trial. J Med Virol. 2012 Aug;84(8):1224-32. doi: 10.1002/jmv.23329.

    PMID: 22711350RESULT

MeSH Terms

Conditions

Herpes Zoster

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Stephen K Tyring, MD

    University of Texas Health Science Center, Houston, Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 28, 2009

Study Start

November 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

December 5, 2013

Record last verified: 2013-12

Locations

US(1)