Study to Compare Efficacy of Topical ARYS-01 (Sorivudine) Cream 3%, Oral Valaciclovir and Combination ARYS-01 Cream 3%/Oral Valaciclovir for Treatment of Herpes Zoster (Shingles)
Information source: aRigen Pharmaceuticals, Inc.
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Zoster; Postherpetic Neuralgia
Intervention: ARYS-01 (sorivudine) cream 3% or placebo cream (Drug); placebo (Drug); valaciclovir (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: aRigen Pharmaceuticals, Inc. Overall contact:
Karen Cha, MA, MBA, Phone: 626-568-8645, Ext: 118, Email: kcha@catalystpharm.com
Summary
A multi-center, randomized, 4-arm, placebo-controlled, double-blind efficacy study of ARYS-01
(sorivudine) cream 3%.
Clinical Details
Official title: Phase 2/3 Multi-Center, Double-Blind, Controlled Trial Comparing Topical ARYS-01 (Sorivudine) Cream 3%, Oral Valaciclovir, and Combination Topical ARYS-01 Cream /Oral Valaciclovir for Treatment of Herpes Zoster in Immunocompetent Patients 18 Years of Age or Older
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The effect of ARYS-01 (sorivudine) cream (with or without Valaciclovir) on the reduction of the crusting stage of VZV rash present at Day 8.
Secondary outcome: The time to cessation of new lesion formation, and time to cessation of Zoster-associated pains, pain intensity, rash healing and size reduction, and lesion dissemination.
Detailed description:
More than 95% of people are infected with varicella Zoster virus (VZV) at one time of life or
another. Primary VZV infection manifests as varicella (chicken pox). The virus then
establishes a latent infection of the sensory ganglia from which it may reactivate years
later to produce the clinical syndrome of Herpes Zoster (shingles). The initial cutaneous VZV
lesions are pruritic, erythematous macules; and the lesions progress through maculopapular
stage to vesicular, ulceration and crusting phases. The crusting phase signals the beginning
of the healing process, and begins with clouding of the vesicular fluid, within about 24 to
48 h after the appearance of each lesion. This is a Phase 2 study to assess: 1) the overall
benefit of ARYS-01 (sorivudine) cream 3% vs. Placebo cream (with immediate or delayed use of
Valaciclovir therapy) on Herpes Zoster rash healing rates and postherpetic neuralgia (PHN),
2) the efficacy of ARYS-01 cream 3% vs. Placebo cream, prior to initiation of Valaciclovir,
to build evidence for monotherapy treatment benefit of ARYS-01 cream on the initial onset of
Herpes Zoster symptoms, 3) the efficacy of ARYS-01 cream 3% vs. Placebo cream, with immediate
or delayed initiation of Valaciclovir, for synergetic effects on the initial onset of Herpes
Zoster symptoms.
The primary efficacy endpoint is the effect of ARYS-01 cream (with or without Valaciclovir)
on the reduction of the crusting stage of VZV rash present at Day 8. Secondary endpoints
include time to cessation of new lesion formation, and time to cessation of Zoster-associated
pains, pain intensity, rash healing and size reduction, and lesion dissemination.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- at least 18 years of age
- diagnosed with herpes zoster
- confirmed for VZV with lesion swab at screening and subsequent PCR test.
- contraception for women of child-bearing potential
- be able to communicate with investigator and compliant
Exclusion Criteria:
- cytotoxic or immunosuppressive drugs within 3 mos, 5-FU or its pro-drugs, tricyclic
antidepressants, probenecid, topical or systemic antiviral drugs or immunomodulatory
agents for viral infection
- herpes zoster ophthalmicus
- female patients who are pregnant and/or nursing or planning a pregnancy
- congenital, acquired or corticosteroid-induced immunodeficiency, including malignancy
- renal insufficiency or creatinine level >2mg/dL
- clinical significant liver enzyme abnormalities and any other laboratory abnormalities
determined by the screening lab
- history of intolerance or hypersensitivity to the cream components
- current significant skin disease within affected dermatome
- history of positive result for hepatitis B surface antigen, hepatitis C virus, or HIV
- current participation in another clinical drug research study
Locations and Contacts
Karen Cha, MA, MBA, Phone: 626-568-8645, Ext: 118, Email: kcha@catalystpharm.com
ARYS-0701 Site 3, Beverly Hills, California 90211, United States; Recruiting
ARYS-0701 Site 6, Encino, California 91436, United States; Recruiting
ARYS-0701 Site 7, Vista, California 92083, United States; Recruiting
ARYS-0701 Site 8, Henderson, Nevada 89014, United States; Recruiting
ARYS-0701 Site 9, Las Vegas, Nevada 89106, United States; Recruiting
ARYS-0701 Site 4, New York, New York 10032, United States; Recruiting
ARYS-0701 Site 10, New York, New York 10003, United States; Recruiting
ARYS-0701 Site 11, New York, New York 10029, United States; Recruiting
ARYS-0701 Site 12, Raleigh, North Carolina 27612, United States; Recruiting
ARYS-0701 Site 1, Houston, Texas 77058, United States; Recruiting
Additional Information
Starting date: March 2008
Ending date: September 2009
Last updated: April 23, 2008
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