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

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ClinicalTrials.gov Identifier: NCT02152800
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : June 2, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Herpes Zoster Drug: valacyclovir hydrocholoride Phase 4

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  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster
Study Start Date : April 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

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



Primary Outcome Measures :
  1. the rash severity, in terms of rash counts [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. VAS Pain score [ Time Frame: Day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152800


Locations
Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Sponsors and Collaborators
Yung Shin Pharm. Ind. Co., Ltd.
Investigators
Principal Investigator: Zhi-Yuan Shi, M.D. Taichung Veterans General Hospital

Responsible Party: Yung Shin Pharm. Ind. Co., Ltd.
ClinicalTrials.gov Identifier: NCT02152800     History of Changes
Other Study ID Numbers: YSP-RCH3002P02
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valacyclovir
Antiviral Agents
Anti-Infective Agents