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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by aRigen Pharmaceuticals, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
aRigen Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00652184
First received: April 1, 2008
Last updated: October 3, 2008
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Herpes Zoster
Postherpetic Neuralgia
Drug: ARYS-01 (sorivudine) cream 3% or placebo cream
Drug: placebo
Drug: valaciclovir
Phase 2

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

Resource links provided by NLM:


Further study details as provided by aRigen Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: March 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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
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: 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
4
Active cream BID for 10 days and active valaciclovir caplets TID from days 1-10
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: valaciclovir
active valaciclovir

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652184

Locations
United States, California
ARYS-0701 Site 3
Beverly Hills, California, United States, 90211
ARYS-0701 Site 6
Encino, California, United States, 91436
ARYS-0701 Site 7
Vista, California, United States, 92083
United States, Nevada
ARYS-0701 Site 8
Henderson, Nevada, United States, 89014
ARYS-0701 Site 9
Las Vegas, Nevada, United States, 89106
United States, New York
ARYS-0701 Site 4
New York, New York, United States, 10032
ARYS-0701 Site 10
New York, New York, United States, 10003
ARYS-0701 Site 11
New York, New York, United States, 10029
United States, North Carolina
ARYS-0701 Site 12
Raleigh, North Carolina, United States, 27612
United States, Texas
ARYS-0701 Site 1
Houston, Texas, United States, 77058
Sponsors and Collaborators
aRigen Pharmaceuticals, Inc.
  More Information

No publications provided by aRigen Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: President and Chief Executive Officer, aRigen Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00652184     History of Changes
Other Study ID Numbers: ARYS-0701
Study First Received: April 1, 2008
Last Updated: October 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by aRigen Pharmaceuticals, Inc.:
antiviral
herpes zoster
postherpetic neuralgia
varicella zoster virus
shingles

Additional relevant MeSH terms:
Neuralgia
Herpes Zoster
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valacyclovir
Acyclovir
Sorivudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014