NCT02152800CompletedPhase 4
A Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster
Yung Shin Pharm. Ind. Co., Ltd.1 site in 1 country25 target enrollmentStarted: April 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- the rash severity, in terms of rash counts
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Valtrex® 500 mg
Active Comparator
Two Valtrex® 500 mg tablets, 3 times daily for 7days
Intervention: valacyclovir hydrocholoride (Drug)
Vacyless® 1000 mg
Experimental
one Vacyless® 1000 mg tablets, 3 times daily for 7days
Intervention: valacyclovir hydrocholoride (Drug)
Vacyless® 500mg
Experimental
Two Vacyless® 500mg tablets, 3 times daily for 7 days
Intervention: valacyclovir hydrocholoride (Drug)
Outcomes
Primary Outcomes
the rash severity, in terms of rash counts
Time Frame: Day 28
Secondary Outcomes
- VAS Pain score(Day 28)
Investigators
Study Sites (1)
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