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)
Recruitment status was Active, not recruiting
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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 |
- 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 ]
- 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:
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:
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:
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 |
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| 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 | |
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:
|
Herpes Zoster Neuralgia Neuralgia, Postherpetic Herpesviridae Infections DNA Virus Infections Virus Diseases Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases |
Neuromuscular Diseases Signs and Symptoms Sorivudine Valacyclovir Acyclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013