Trial record 14 of 231 for:    "Herpes Zoster" [DISEASE]

A Phase 2b Trial of EPB-348 for the Treatment of Herpes Zoster

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Epiphany Biosciences
ClinicalTrials.gov Identifier:
NCT00831103
First received: January 26, 2009
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Herpes Zoster
Drug: EPB-348
Drug: Valacyclovir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Active-controlled, Multi-center, Parallel-group Dose-ranging Study Assessing the Safety and Efficacy of EPB-348 Versus Valacyclovir Among Immunocompetent Patients With an Acute Episode of Herpes Zoster

Resource links provided by NLM:


Further study details as provided by Epiphany Biosciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 373
Study Start Date: November 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EPB-348 1000 mg
EPB-348 1000 mg dosed once daily for seven days
Drug: EPB-348
Treated over seven days
Other Name: Valomaciclovir Stearate
Experimental: EPB-348 2000 mg
EPB-348 2000 mg dosed once daily for seven days
Drug: EPB-348
Treated over seven days
Other Name: Valomaciclovir Stearate
Experimental: EPB-348 3000 mg
EPB-348 3000 mg dosed once daily for seven days
Drug: EPB-348
Treated over seven days
Other Name: Valomaciclovir Stearate
Active Comparator: Valacyclovir
Valacyclovir 1000 mg dosed three times daily for seven days
Drug: Valacyclovir
Treated over seven days
Other Name: Valtrex

Detailed Description:

In cells infected with varicella-zoster virus, there is evidence to suggest that EPB-348 could offer clinically important advantages in the treatment of acute herpes zoster over currently available therapies due to rapid absorption and conversion to the active moiety as well as a longer intra-cellular half-life in infected cells. Clinically, these characteristics could translate into once-daily dosing versus thrice-daily dosing as seen with current therapy, leading to a higher rate of compliance and quality-of-life, especially among elderly patients. The objective of EPB348-0201 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. This multi-center study will randomly assign patients to either EPB-348 1000 mg once daily or EPB-348 2000 mg once daily or valacyclovir 1000 mg three times daily.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831103

Locations
United States, Texas
Center for Clinical Studies-Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Epiphany Biosciences
Investigators
Principal Investigator: Stephen K Tyring, MD University of Texas Health Science Center, Houston, Texas
  More Information

Publications:
Responsible Party: Epiphany Biosciences
ClinicalTrials.gov Identifier: NCT00831103     History of Changes
Other Study ID Numbers: EPB348-0201
Study First Received: January 26, 2009
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Epiphany Biosciences:
EPB348
Valomaciclovir Stearate
Valacyclovir
Herpes Zoster
Shingles

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014