Herpes ZosterPhase 2NCT00652184
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)
A Phase 2 study testing valaciclovir in people with Herpes Zoster and Postherpetic Neuralgia, run by aRigen Pharmaceuticals, Inc. at 10 sites in United States.
Trial summary
A multi-center, randomized, 4-arm, placebo-controlled, double-blind efficacy study of ARYS-01 (sorivudine) cream 3%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Zoster, Postherpetic Neuralgia
- What is being tested?
- valaciclovir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 10 sitesUnited States
- Study dates
- Mar 2008to Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
ARYS-0701 Site 3
Beverly Hills, California, 90211
ARYS-0701 Site 6
Encino, California, 91436
ARYS-0701 Site 8
Henderson, Nevada, 89014
ARYS-0701 Site 1
Houston, Texas, 77058
ARYS-0701 Site 9
Las Vegas, Nevada, 89106
ARYS-0701 Site 10
New York, New York, 10003
ARYS-0701 Site 11
New York, New York, 10029
ARYS-0701 Site 4
New York, New York, 10032
ARYS-0701 Site 12
Raleigh, North Carolina, 27612
ARYS-0701 Site 7
Vista, California, 92083
About this 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
A multi-center, randomized, 4-arm, placebo-controlled, double-blind efficacy study of ARYS-01 (sorivudine) cream 3%.
Read the 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.
- Conditions
- Herpes Zoster, Postherpetic Neuralgia
- Being tested
- ARYS-01 (sorivudine) cream 3% or placebo cream, placebo, valaciclovir
- Keywords
- antiviral, herpes zoster, postherpetic neuralgia, varicella zoster virus, shingles
- Medical subject headings
- Herpes Zoster, Neuralgia, Postherpetic, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARYS-01 (sorivudine) cream 3% or placebo creamDrug
Also called ARYS-01 cream 3%, sorivudine cream 3%, topical sorivudine 3%
sorivudine cream 3% or placebo cream twice daily for 10 days
placeboDrug
placebo cream and placebo valaciclovir
valaciclovirDrug
active valaciclovir
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: placebo; Drug: valaciclovir |
| 2 | Active comparator | Placebo cream BID for 10 days and active valaciclovir caplets TID from days 1-10 Receives: 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 Receives: 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 Receives: Drug: ARYS-01 (sorivudine) cream 3% or placebo cream; Drug: valaciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- aRigen Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652184
- Sponsor's protocol ID
- ARYS-0701
- Status last verified
- Oct 2008
- First submitted
- 1 Apr 2008
- Last updated
- 7 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19469706
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00652184
- Acronym / sponsor ID
- ARYS-0701
- Conditions
- Herpes Zoster, Postherpetic Neuralgia
- Keywords
- antiviral, herpes zoster, postherpetic neuralgia, varicella zoster virus, shingles
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- aRigen Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 3 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placebo, Drug: valaciclovirPlacebo 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 |
| 2 | Active comparator | Drug: ARYS-01 (sorivudine) cream 3% or placebo cream, Drug: placebo, Drug: valaciclovirPlacebo cream BID for 10 days and active valaciclovir caplets TID from days 1-10 |
| 3 | Experimental | Drug: ARYS-01 (sorivudine) cream 3% or placebo cream, Drug: placebo, Drug: valaciclovirActive 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 |
| 4 | Other | Drug: ARYS-01 (sorivudine) cream 3% or placebo cream, Drug: valaciclovirActive cream BID for 10 days and active valaciclovir caplets TID from days 1-10 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARYS-01 (sorivudine) cream 3% or placebo creamAlso: ARYS-01 cream 3%, sorivudine cream 3%, topical sorivudine 3%sorivudine cream 3% or placebo cream twice daily for 10 days | Drug | 2, 3, 4 |
| placeboplacebo cream and placebo valaciclovir | Drug | 1, 2, 3 |
| valacicloviractive valaciclovir | Drug | 1, 2, 3, 4 |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2008.
- Derived from this study: PubMed 19469706Satyaprakash 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing valaciclovir in people with Herpes Zoster and Postherpetic Neuralgia, run by aRigen Pharmaceuticals, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00652184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2008.