Status:
UNKNOWN
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)
Lead Sponsor:
aRigen Pharmaceuticals, Inc.
Conditions:
Herpes Zoster
Postherpetic Neuralgia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00652184
Start Date
March 1 2008
End Date
September 1 2009
Last Update
October 7 2008
Active Locations (10)
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1
ARYS-0701 Site 3
Beverly Hills, California, United States, 90211
2
ARYS-0701 Site 6
Encino, California, United States, 91436
3
ARYS-0701 Site 7
Vista, California, United States, 92083
4
ARYS-0701 Site 8
Henderson, Nevada, United States, 89014