A Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster

Phase 4

Completed

• Conditions: Herpes Zoster
• Interventions: Drug: valacyclovir hydrocholoride

• Registration Number: NCT02152800
• Lead Sponsor: Yung Shin Pharm. Ind. Co., Ltd.

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 Timeline

• Study Start: 2011-04
• Primary Completion: 2013-09
• Study Completion: 2013-11
• Study First Submitted: 2014-03-13
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-28
• Last Update Submitted: 2014-05-28
• Study First Posted: 2014-06-02
• Last Update Posted: 2014-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vacyless® 1000 mg	valacyclovir hydrocholoride	one Vacyless® 1000 mg tablets, 3 times daily for 7days
Valtrex® 500 mg	valacyclovir hydrocholoride	Two Valtrex® 500 mg tablets, 3 times daily for 7days
Vacyless® 500mg	valacyclovir hydrocholoride	Two Vacyless® 500mg tablets, 3 times daily for 7 days

Primary Outcome Measures

Name	Time	Method
the rash severity, in terms of rash counts	Day 28

Secondary Outcome Measures

Name	Time	Method
VAS Pain score	Day 28

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan