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)

October 3, 2008 updated by: aRigen Pharmaceuticals, Inc.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • ARYS-0701 Site 3
      • Encino, California, United States, 91436
        • ARYS-0701 Site 6
      • Vista, California, United States, 92083
        • ARYS-0701 Site 7
    • Nevada
      • Henderson, Nevada, United States, 89014
        • ARYS-0701 Site 8
      • Las Vegas, Nevada, United States, 89106
        • ARYS-0701 Site 9
    • New York
      • New York, New York, United States, 10003
        • ARYS-0701 Site 10
      • New York, New York, United States, 10029
        • ARYS-0701 Site 11
      • New York, New York, United States, 10032
        • ARYS-0701 Site 4
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • ARYS-0701 Site 12
    • Texas
      • Houston, Texas, United States, 77058
        • ARYS-0701 Site 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
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
Drug: placebo
placebo cream and placebo valaciclovir
Drug: valaciclovir
active valaciclovir
Active Comparator: 2
Placebo cream BID for 10 days and active valaciclovir caplets TID from days 1-10
Drug: placebo
placebo cream and placebo valaciclovir
Drug: valaciclovir
active valaciclovir
Drug: ARYS-01 (sorivudine) cream 3% or placebo cream
sorivudine cream 3% or placebo cream twice daily for 10 days
Other Names:
  • ARYS-01 cream 3%
  • sorivudine cream 3%
  • topical sorivudine 3%
Experimental: 3
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
Drug: placebo
placebo cream and placebo valaciclovir
Drug: valaciclovir
active valaciclovir
Drug: ARYS-01 (sorivudine) cream 3% or placebo cream
sorivudine cream 3% or placebo cream twice daily for 10 days
Other Names:
  • ARYS-01 cream 3%
  • sorivudine cream 3%
  • topical sorivudine 3%
Other: 4
Active cream BID for 10 days and active valaciclovir caplets TID from days 1-10
Drug: valaciclovir
active valaciclovir
Drug: ARYS-01 (sorivudine) cream 3% or placebo cream
sorivudine cream 3% or placebo cream twice daily for 10 days
Other Names:
  • ARYS-01 cream 3%
  • sorivudine cream 3%
  • topical sorivudine 3%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 8

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

aRigen Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Anticipated)

June 1, 2009

Study Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 2, 2008

First Posted (Estimate)

April 3, 2008

Study Record Updates

Last Update Posted (Estimate)

October 7, 2008

Last Update Submitted That Met QC Criteria

October 3, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARYS-0701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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