Back to resultsA Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster (Vacyless®)
Primary Purpose
Herpes Zoster
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
valacyclovir hydrocholoride
Sponsored by
About this trial
This is an interventional treatment trial for Herpes Zoster
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Taichung Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Vacyless® 1000 mg
Vacyless® 500mg
Valtrex® 500 mg
Arm Description
one Vacyless® 1000 mg tablets, 3 times daily for 7days
Two Vacyless® 500mg tablets, 3 times daily for 7 days
Two Valtrex® 500 mg tablets, 3 times daily for 7days
Outcomes
Primary Outcome Measures
the rash severity, in terms of rash counts
Secondary Outcome Measures
VAS Pain score
Full Information
NCT ID
NCT02152800
First Posted
March 13, 2014
Last Updated
May 28, 2014
Sponsor
Yung Shin Pharm. Ind. Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02152800
Brief Title
A Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster
Acronym
Vacyless®
Official Title
A Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yung Shin Pharm. Ind. Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vacyless® 1000 mg
Arm Type
Experimental
Arm Description
one Vacyless® 1000 mg tablets, 3 times daily for 7days
Arm Title
Vacyless® 500mg
Arm Type
Experimental
Arm Description
Two Vacyless® 500mg tablets, 3 times daily for 7 days
Arm Title
Valtrex® 500 mg
Arm Type
Active Comparator
Arm Description
Two Valtrex® 500 mg tablets, 3 times daily for 7days
Intervention Type
Drug
Intervention Name(s)
valacyclovir hydrocholoride
Primary Outcome Measure Information:
Title
the rash severity, in terms of rash counts
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
VAS Pain score
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi-Yuan Shi, M.D.
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster
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