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Efficacy of Oral Famciclovir Versus Aciclovir Treatment in Patients With Herpes Zoster

Primary Purpose

Herpes Zoster

Status

Completed

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Famciclovir

Aciclovir

About this trial

This is an interventional treatment trial for Herpes Zoster

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Centro de Medicina Reprodutiva Dr Carlos Isaia Filho
Loema
CECIP Centro de Estudos Clínicos do Interior Paulista
Afip - Associacao Fundo de Incentivo A Pesquisa
Allergisa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Famciclovir 500mg

Aciclovir 400mg

Arm Description

1 tablet each 8 hours for 7 days

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety will be evaluated by the adverse events occurrences

Adverse events will be collected and followed in order to evaluate safety and tolerability

Full Information

NCT ID

NCT01327144

First Posted

March 30, 2011

Last Updated

April 15, 2019

Sponsor

EMS

1. Study Identification

Unique Protocol Identification Number

NCT01327144

Brief Title

Efficacy of Oral Famciclovir Versus Aciclovir Treatment in Patients With Herpes Zoster

Official Title

A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Famciclovir 500 mg Comparing To Aciclovir 400mg in Patients With Herpes Zoster

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

June 2012 (Actual)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EMS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Study Design single blind study, prospective, parallel group, intent to treat trial Experiment duration: 7 days 2 visits (days 0, and 7) Reduction of symptoms Adverse events evaluation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Herpes Zoster

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

177 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Famciclovir 500mg

Arm Type

Experimental

Arm Description

1 tablet each 8 hours for 7 days

Arm Title

Aciclovir 400mg

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Famciclovir

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Aciclovir

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

day 7

Secondary Outcome Measure Information:

Title

Safety will be evaluated by the adverse events occurrences

Description

Adverse events will be collected and followed in order to evaluate safety and tolerability

Time Frame

day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joyce Silva, MD

Organizational Affiliation

EMS

Official's Role

Study Director

Facility Information:

Facility Name

Centro de Medicina Reprodutiva Dr Carlos Isaia Filho

City

Porto Alegre

State/Province

Country

Brazil

Facility Name

Loema

City

Campinas

State/Province

ZIP/Postal Code

13010001

Country

Brazil

Facility Name

CECIP Centro de Estudos Clínicos do Interior Paulista

City

Jau

State/Province

Country

Brazil

Facility Name

Afip - Associacao Fundo de Incentivo A Pesquisa

City

Sao Paulo

State/Province

Country

Brazil

Facility Name

Allergisa

City

Campinas

State/Province

São Paulo

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

29746903

Citation

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.

Results Reference

result

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Efficacy of Oral Famciclovir Versus Aciclovir Treatment in Patients With Herpes Zoster

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