Overview

This trial is active, not recruiting.

Conditions herpes zoster, postherpetic neuralgia
Treatments arys-01 (sorivudine) cream 3% or placebo cream, placebo, valaciclovir
Phase phase 2
Sponsor aRigen Pharmaceuticals, Inc.
Start date March 2008
End date June 2009
Trial size 300 participants
Trial identifier NCT00652184, ARYS-0701

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo cream BID for 10 days and placebo valaciclovir caplets TID from days 1-3 and active valaciclovir caplets 1 gram TID from days 4-10
placebo
placebo cream and placebo valaciclovir
valaciclovir
active valaciclovir
(Active Comparator)
Placebo cream BID for 10 days and active valaciclovir caplets TID from days 1-10
arys-01 (sorivudine) cream 3% or placebo cream ARYS-01 cream 3%
sorivudine cream 3% or placebo cream twice daily for 10 days
placebo
placebo cream and placebo valaciclovir
valaciclovir
active valaciclovir
(Experimental)
Active cream BID for 10 days and placebo valaciclovir caplets TID from days 1-3 and active valaciclovir caplets 1 gram TID from days 4-10
arys-01 (sorivudine) cream 3% or placebo cream ARYS-01 cream 3%
sorivudine cream 3% or placebo cream twice daily for 10 days
placebo
placebo cream and placebo valaciclovir
valaciclovir
active valaciclovir
(Other)
Active cream BID for 10 days and active valaciclovir caplets TID from days 1-10
arys-01 (sorivudine) cream 3% or placebo cream ARYS-01 cream 3%
sorivudine cream 3% or placebo cream twice daily for 10 days
valaciclovir
active valaciclovir

Primary Outcomes

Measure
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.
time frame: Day 8

Secondary Outcomes

Measure
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.
time frame: Day 4

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2008.
Information provided to ClinicalTrials.gov by aRigen Pharmaceuticals, Inc..