NCT02152800

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
Last Updated

June 2, 2014

Status Verified

May 1, 2014

Enrollment Period

2.4 years

First QC Date

March 13, 2014

Last Update Submit

May 28, 2014

Conditions

Herpes Zoster

Outcome Measures

Primary Outcomes (1)

  • the rash severity, in terms of rash counts

    Day 28

Secondary Outcomes (1)

  • VAS Pain score

    Day 28

Study Arms (3)

Vacyless® 1000 mg

EXPERIMENTAL

one Vacyless® 1000 mg tablets, 3 times daily for 7days

Drug: valacyclovir hydrocholoride

Vacyless® 500mg

EXPERIMENTAL

Two Vacyless® 500mg tablets, 3 times daily for 7 days

Drug: valacyclovir hydrocholoride

Valtrex® 500 mg

ACTIVE COMPARATOR

Two Valtrex® 500 mg tablets, 3 times daily for 7days

Drug: valacyclovir hydrocholoride

Interventions

valacyclovir hydrocholorideDRUG
Vacyless® 1000 mgVacyless® 500mgValtrex® 500 mg

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Zhi-Yuan Shi, M.D.

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2014

First Posted

June 2, 2014

Study Start

April 1, 2011

Primary Completion

September 1, 2013

Study Completion

November 1, 2013

Last Updated

June 2, 2014

Record last verified: 2014-05

Locations

TW(1)