Herpes ZosterPhase 4Vacyless®NCT02152800
A Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster
A Phase 4 study testing valacyclovir hydrocholoride in people with Herpes Zoster, run by Yung Shin Pharm. Ind. Co., Ltd. at 1 site in Taiwan.
Trial summary
The purpose of this study is to compare the safety and efficacy of Vacyless® and Valtrex® in patients with acute herpes zoster. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- valacyclovir hydrocholoride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2011to Nov 2013
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between 20 to 80 years of age.
- Patients with a clinical diagnosis of HZ as evidenced by a unilateral dermatomal rash.
- Patients with zoster-related rash (rash severity is greater than or equal to mild).
- Patients are able to be enrolled into the study 72 hours from appearance of rash (for example, lesions or vesicles).
- Patients provided written informed consent.
- Patients who are able to complete all study visits per protocol.
- Men and premenopausal women must agree to practice a barrier method of birth control or the use of a spermicide for one month after the last dose of study drug (oral contraceptives are not permitted). Subject should be withdrew from the study if contraceptions are faild.
Who cannot join
- Women who are pregnant or lactating.
- Patients with multidermatomal or disseminated HZ (greater than 20 lesions beyond the dermatomes adjacent to the primarily involved dermatome).
- Patients with HZ ophthalmicus, defined as cutaneous lesions in the dermatome associated with the ophthalmic division of the trigeminal nerve
- Patients with history of impaired renal function, (e.g., calculated creatinine clearance less than 50 mL/min/1.73 m2)
- Patients are taking narcotic analgesic routinely for a chronic pain condition
- Patients are taking tricyclic antidepressants
Show all 13Show fewer
- Patients who received systemic antivirals with activity against VZV within the past 30 days, or a topical antiviral to treat their current HZ
- Patients with immunosuppressive or immunodeficient condition resulting from:
- disease (e.g., HIV) corticosteroid use (except intermittent or topical/inhaled beclomethasone dipropionate or equivalent < 800 mcg/day), or other immunosuppressive/cytotoxic therapy (cancer chemotherapy or organ transplantation )
- Patients with any other condition (e.g., extensive psoriasis, chronic pain syndrome, cognitive impairment) that, in the opinion of the site investigator, might interfere with the evaluations required by the study
- Patients who are not ambulatory (bed-ridden or homebound); hospitalized patients may be enrolled if they are ambulatory and able to complete the study requirements
- Patients with history of allergy to valacyclovir hydrochloride and acetaminophen
- Patients are unlikely to adhere to protocol follow-up
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the safety and efficacy of Vacyless® and Valtrex® in patients with acute herpes zoster.
Read the detailed description
Primary Endpoint:
- Lesion assessment - Rash severity, in terms of rash counts
Secondary Endpoints:
- Pain assessment
- Clinical global impression
- Safety information of valacyclovir
- Conditions
- Herpes Zoster
- Being tested
- valacyclovir hydrocholoride
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valacyclovir hydrocholorideDrug
| Study group | Role | What they receive |
|---|---|---|
| Vacyless® 1000 mg | Experimental | one Vacyless® 1000 mg tablets, 3 times daily for 7days Receives: Drug: valacyclovir hydrocholoride |
| Vacyless® 500mg | Experimental | Two Vacyless® 500mg tablets, 3 times daily for 7 days Receives: Drug: valacyclovir hydrocholoride |
| Valtrex® 500 mg | Active comparator | Two Valtrex® 500 mg tablets, 3 times daily for 7days Receives: Drug: valacyclovir hydrocholoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rash severity, in terms of rash counts
Measured: Day 28
Secondary outcomes (1)
VAS Pain score
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startApr 2011
- Primary completionSep 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhi-Yuan Shi, M.D., Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152800
- Sponsor's protocol ID
- YSP-RCH3002P02
- Acronym
- Vacyless®
- Status last verified
- May 2014
- First submitted
- 13 Mar 2014
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster
- ClinicalTrials.gov ID
- NCT02152800
- Acronym / sponsor ID
- Vacyless® / YSP-RCH3002P02
- Conditions
- Herpes Zoster
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Yung Shin Pharm. Ind. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 2 Jun 2014 (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.
The purpose of this study is to compare the safety and efficacy of Vacyless® and Valtrex® in patients with acute herpes zoster.
Detailed description
Primary Endpoint:
- Lesion assessment - Rash severity, in terms of rash counts
Secondary Endpoints:
- Pain assessment
- Clinical global impression
- Safety information of valacyclovir
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vacyless® 1000 mg | Experimental | Drug: valacyclovir hydrocholorideone Vacyless® 1000 mg tablets, 3 times daily for 7days |
| Vacyless® 500mg | Experimental | Drug: valacyclovir hydrocholorideTwo Vacyless® 500mg tablets, 3 times daily for 7 days |
| Valtrex® 500 mg | Active comparator | Drug: valacyclovir hydrocholorideTwo Valtrex® 500 mg tablets, 3 times daily for 7days |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women between 20 to 80 years of age.
- Patients with a clinical diagnosis of HZ as evidenced by a unilateral dermatomal rash.
- Patients with zoster-related rash (rash severity is greater than or equal to mild).
- Patients are able to be enrolled into the study 72 hours from appearance of rash (for example, lesions or vesicles).
- Patients provided written informed consent.
Key exclusion criteria (13 listed)
- Women who are pregnant or lactating.
- Patients with multidermatomal or disseminated HZ (greater than 20 lesions beyond the dermatomes adjacent to the primarily involved dermatome).
- Patients with HZ ophthalmicus, defined as cutaneous lesions in the dermatome associated with the ophthalmic division of the trigeminal nerve
- Patients with history of impaired renal function, (e.g., calculated creatinine clearance less than 50 mL/min/1.73 m2)
- Patients are taking narcotic analgesic routinely for a chronic pain condition
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 |
|---|---|---|
| valacyclovir hydrocholoride | Drug | Vacyless® 1000 mg, Vacyless® 500mg, Valtrex® 500 mg |
Primary outcome
the rash severity, in terms of rash counts
Time frame: Day 28
1 secondary outcome
VAS Pain score
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
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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.
Zhi-Yuan Shi, M.D. principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valacyclovir hydrocholoride in people with Herpes Zoster, run by Yung Shin Pharm. Ind. Co., Ltd. at 1 site in Taiwan.
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 7 inclusion and 13 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: finished, as of the sponsor's last update on 2 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 rash severity, in terms of rash counts (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2014.