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

EMS

Status and phase

Completed

Phase 3

Conditions

Herpes Zoster

Treatments

Drug: Famciclovir

Drug: Aciclovir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01327144

F500EMS1010

Details and patient eligibility

About

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.

Full 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

Enrollment

177 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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.