NCT01327144

Brief Summary

Herpes Zoster is an infection that affects part of the nervous system caused by Varicella Zoster Virus. Herpes Zoster manifests as vesicular eruption in the dermatome, often associated with significant pain. There are effective oral prescription antiviral medicines available to reduce the discomfort of symptoms as famciclovir and aciclovir. This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy and safety of treatment with Famciclovir (500 mg) comparing to Aciclovir (400 mg) in patients with Herpes Zoster.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_3

Geographic Reach
1 country

5 active sites

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

First Submitted

Initial submission to the registry

March 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2011

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

4.9 years

First QC Date

March 30, 2011

Last Update Submit

April 15, 2019

Conditions

Herpes Zoster

Outcome Measures

Primary Outcomes (1)

  • For efficacy evaluation, a visual analogue scale (VAS) will be used to detect the improvement of symptoms

    Symptoms evaluated: pain, injury, loss of sensation, burning and itching

    day 7

Secondary Outcomes (1)

  • Safety will be evaluated by the adverse events occurrences

    day 7

Study Arms (2)

Famciclovir 500mg

EXPERIMENTAL

1 tablet each 8 hours for 7 days

Drug: Famciclovir

Aciclovir 400mg

ACTIVE COMPARATOR

2 tablets of Aciclovir 400 mg each 4 hours for 7 days

Drug: Aciclovir

Interventions

FamciclovirDRUG

Famciclovir 500 mg- 1 tablet each 12 hours for 7 days

Famciclovir 500mg
AciclovirDRUG

Aciclovir 400 mg- 02 tablets each 4 hours for 7 days

Aciclovir 400mg

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients must be able to understand the study procedures, agree to participate and give written consent.
  • Patients with clinical diagnosis of Herpes Zoster;
  • Score higher than 4 for at least for 2 symptoms of Herpes Zoster;
  • Negative pregnant urine test

You may not qualify if:

  • Pregnancy or risk of pregnancy.
  • Lactation
  • Any pathology or past medical condition that can interfere with this protocol.
  • Non-steroidal anti-inflammatory drug , hormonal anti-inflammatory or immunosuppressive drugs (in the last 30 days and during the study);
  • Patients with immunodeficiency and/or immunosuppressive disease;
  • Hypersensitivity to components of the formula;
  • Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centro de Medicina Reprodutiva Dr Carlos Isaia Filho

Porto Alegre, Rio Grande do Sul, Brazil

Location

Loema

Campinas, São Paulo, 13010001, Brazil

Location

Allergisa

Campinas, São Paulo, Brazil

Location

CECIP Centro de Estudos Clínicos do Interior Paulista

Jaú, São Paulo, Brazil

Location

Afip - Associacao Fundo de Incentivo A Pesquisa

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • Pott Junior H, de Oliveira MFB, Gambero S, Amazonas RB. Randomized clinical trial of famciclovir or acyclovir for the treatment of herpes zoster in adults. Int J Infect Dis. 2018 Jul;72:11-15. doi: 10.1016/j.ijid.2018.04.4324. Epub 2018 May 7.

    PMID: 29746903RESULT

MeSH Terms

Conditions

Herpes Zoster

Interventions

FamciclovirAcyclovir

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

AdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGuanineHypoxanthinesPurinones

Study Officials

  • Joyce Silva, MD

    EMS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2011

First Posted

April 1, 2011

Study Start

June 1, 2012

Primary Completion

May 1, 2017

Study Completion

July 1, 2017

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

BR(5)