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

Herpes Zoster Clinical Trial

— Vacyless®  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152800
• Other study ID #: YSP-RCH3002P02
• Status: Completed
• Phase: Phase 4
• First received: March 13, 2014
• Last updated: May 28, 2014
• Start date: April 2011
• Est. completion date: November 2013

Study information

• Verified date: May 2014
• Source: Yung Shin Pharm. Ind. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and efficacy of Vacyless® and Valtrex® in patients with acute herpes zoster.

Description:

Primary Endpoint:

• Lesion assessment - Rash severity, in terms of rash counts

Secondary Endpoints:

• Pain assessment

• Clinical global impression

• Safety information of valacyclovir

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Drug:
• valacyclovir hydrocholoride

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Yung Shin Pharm. Ind. Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rash severity, in terms of rash counts		Day 28	No
Secondary	VAS Pain score		Day 28	Yes