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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)

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ClinicalTrials.gov Identifier: NCT00652184
Recruitment Status : Unknown
Verified October 2008 by aRigen Pharmaceuticals, Inc..
Recruitment status was:  Active, not recruiting
First Posted : April 3, 2008
Last Update Posted : October 7, 2008
Sponsor:
Information provided by:
aRigen Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE April 1, 2008
First Posted Date  ICMJE April 3, 2008
Last Update Posted Date October 7, 2008
Study Start Date  ICMJE March 2008
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
Brief Summary A multi-center, randomized, 4-arm, placebo-controlled, double-blind efficacy study of ARYS-01 (sorivudine) cream 3%.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Herpes Zoster
  • Postherpetic Neuralgia
Intervention  ICMJE
  • 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%
  • Drug: placebo
    placebo cream and placebo valaciclovir
  • Drug: valaciclovir
    active valaciclovir
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: placebo
    • Drug: valaciclovir
  • Active Comparator: 2
    Placebo cream BID for 10 days and active valaciclovir caplets TID from days 1-10
    Interventions:
    • Drug: ARYS-01 (sorivudine) cream 3% or placebo cream
    • Drug: placebo
    • Drug: valaciclovir
  • 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
    Interventions:
    • Drug: ARYS-01 (sorivudine) cream 3% or placebo cream
    • Drug: placebo
    • Drug: valaciclovir
  • 4
    Active cream BID for 10 days and active valaciclovir caplets TID from days 1-10
    Interventions:
    • Drug: ARYS-01 (sorivudine) cream 3% or placebo cream
    • Drug: valaciclovir
Publications * Satyaprakash AK, Tremaine AM, Stelter AA, Creed R, Ravanfar P, Mendoza N, Mehta SK, Rady PL, Pierson DL, Tyring SK. Viremia in acute herpes zoster. J Infect Dis. 2009 Jul 1;200(1):26-32. doi: 10.1086/599381.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 2, 2008)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2009
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00652184
Other Study ID Numbers  ICMJE ARYS-0701
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party President and Chief Executive Officer, aRigen Pharmaceuticals, Inc.
Study Sponsor  ICMJE aRigen Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account aRigen Pharmaceuticals, Inc.
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP