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

Herpes Zoster Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327144
• Other study ID #: F500EMS1010
• Status: Completed
• Phase: Phase 3
• Start date: June 2012
• Est. completion date: July 2017

Study information

• Verified date: April 2019
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Drug:
• Famciclovir
Famciclovir 500 mg- 1 tablet each 12 hours for 7 days
• Aciclovir
Aciclovir 400 mg- 02 tablets each 4 hours for 7 days

Locations

Country	Name	City	State
Brazil	Allergisa	Campinas	São Paulo
Brazil	Loema	Campinas	SP
Brazil	CECIP Centro de Estudos Clínicos do Interior Paulista	Jau	SP
Brazil	Centro de Medicina Reprodutiva Dr Carlos Isaia Filho	Porto Alegre	RS
Brazil	Afip - Associacao Fundo de Incentivo A Pesquisa	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety will be evaluated by the adverse events occurrences	Adverse events will be collected and followed in order to evaluate safety and tolerability	day 7