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

May 28, 2014 updated by: Yung Shin Pharm. Ind. Co., Ltd.
The purpose of this study is to compare the safety and efficacy of Vacyless® and Valtrex® in patients with acute herpes zoster.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • Taichung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vacyless® 1000 mg
one Vacyless® 1000 mg tablets, 3 times daily for 7days
Drug: valacyclovir hydrocholoride
EXPERIMENTAL: Vacyless® 500mg
Two Vacyless® 500mg tablets, 3 times daily for 7 days
Drug: valacyclovir hydrocholoride
ACTIVE_COMPARATOR: Valtrex® 500 mg
Two Valtrex® 500 mg tablets, 3 times daily for 7days
Drug: valacyclovir hydrocholoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the rash severity, in terms of rash counts
Time Frame: Day 28
Day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
VAS Pain score
Time Frame: Day 28
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yung Shin Pharm. Ind. Co., Ltd.

Investigators

  • Principal Investigator: Zhi-Yuan Shi, M.D., Taichung Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

March 13, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (ESTIMATE)

June 2, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 2, 2014

Last Update Submitted That Met QC Criteria

May 28, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YSP-RCH3002P02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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