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) - Full Text View

Sponsor:	aRigen Pharmaceuticals, Inc.
Information provided by:	aRigen Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00652184

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Shingles

Drug Information available for: Sorivudine Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources

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

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 National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	aRigen Pharmaceuticals, Inc. ( President and Chief Executive Officer )
Study ID Numbers:	ARYS-0701
Study First Received:	April 1, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00652184 History of Changes
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:

Herpes Zoster
Neuralgia, Postherpetic
Anti-Infective Agents
Neuralgia
Nervous System Diseases
Pain
Antiviral Agents
Pharmacologic Actions
Herpesviridae Infections
Valacyclovir

Virus Diseases
Signs and Symptoms
Acyclovir
Neuromuscular Diseases
Therapeutic Uses
Peripheral Nervous System Diseases
Neurologic Manifestations
DNA Virus Infections
Sorivudine

ClinicalTrials.gov processed this record on February 08, 2010