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)

NCT00652184 | Unknown Phase 2

• 1 other identifier: ARYS-0701
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Herpes Zoster; Postherpetic Neuralgia

Keywords

antiviral; herpes zoster; postherpetic neuralgia; varicella zoster virus; shingles

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 8

Secondary Outcomes (1)

• 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.

  Day 4

Study Arms (4)

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; Drug: 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; Drug: placebo; Drug: 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; Drug: placebo; Drug: valaciclovir

4

OTHER

Active cream BID for 10 days and active valaciclovir caplets TID from days 1-10

Drug: ARYS-01 (sorivudine) cream 3% or placebo cream; Drug: valaciclovir

Interventions

ARYS-01 (sorivudine) cream 3% or placebo cream DRUG

sorivudine cream 3% or placebo cream twice daily for 10 days

Also known as: ARYS-01 cream 3%, sorivudine cream 3%, topical sorivudine 3%

2; 3; 4

placebo DRUG

placebo cream and placebo valaciclovir

1; 2; 3

valaciclovir DRUG

active valaciclovir

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• aRigen Pharmaceuticals, Inc.: lead

Study Sites (10)

ARYS-0701 Site 3

Beverly Hills, California, 90211, United States

Location

ARYS-0701 Site 6

Encino, California, 91436, United States

Location

ARYS-0701 Site 7

Vista, California, 92083, United States

Location

ARYS-0701 Site 8

Henderson, Nevada, 89014, United States

Location

ARYS-0701 Site 9

Las Vegas, Nevada, 89106, United States

Location

ARYS-0701 Site 10

New York, New York, 10003, United States

Location

ARYS-0701 Site 11

New York, New York, 10029, United States

Location

ARYS-0701 Site 4

New York, New York, 10032, United States

Location

ARYS-0701 Site 12

Raleigh, North Carolina, 27612, United States

Location

ARYS-0701 Site 1

Houston, Texas, 77058, United States

Location

Related Publications (1)

• 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.

  PMID: 19469706 DERIVED

MeSH Terms

Conditions

Herpes Zoster; Neuralgia, Postherpetic; Chickenpox

Interventions

sorivudine; Valacyclovir

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 3, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 7, 2008

Record last verified: 2008-10

Locations

US (10)