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)

Herpes Zoster Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00652184
• Other study ID #: ARYS-0701
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 1, 2008
• Last updated: October 3, 2008
• Start date: March 2008
• Est. completion date: September 2009

Study information

• Verified date: October 2008
• Source: aRigen Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A multi-center, randomized, 4-arm, placebo-controlled, double-blind efficacy study of ARYS-01 (sorivudine) cream 3%.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Zoster
• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

Drug:
• ARYS-01 (sorivudine) cream 3% or placebo cream
sorivudine cream 3% or placebo cream twice daily for 10 days
• placebo
placebo cream and placebo valaciclovir
• valaciclovir
active valaciclovir

Locations

Country	Name	City	State
United States	ARYS-0701 Site 3	Beverly Hills	California
United States	ARYS-0701 Site 6	Encino	California
United States	ARYS-0701 Site 8	Henderson	Nevada
United States	ARYS-0701 Site 1	Houston	Texas
United States	ARYS-0701 Site 9	Las Vegas	Nevada
United States	ARYS-0701 Site 10	New York	New York
United States	ARYS-0701 Site 11	New York	New York
United States	ARYS-0701 Site 4	New York	New York
United States	ARYS-0701 Site 12	Raleigh	North Carolina
United States	ARYS-0701 Site 7	Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
aRigen Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Day 8	No
Secondary	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.		Day 4	No