Herpes Zoster | Efficacy of Oral Famciclovir Versus Aciclovir Treatment in Patients With Herpes Zoster
Herpes Zoster research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:FamciclovirFamciclovir 500 mg- 1 tablet each 12 hours for 7 days
Drug:AciclovirAciclovir 400 mg- 02 tablets each 4 hours for 7 days
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Famciclovir 500mg1 tablet each 8 hours for 7 days
Aciclovir 400mg2 tablets of Aciclovir 400 mg each 4 hours for 7 days
Start Date: June 2012
Completed Date: July 2017
Phase: Phase 3
Primary Outcome: For efficacy evaluation, a visual analogue scale (VAS) will be used to detect the improvement of symptoms
Secondary Outcome: Safety will be evaluated by the adverse events occurrences
Study sponsors, principal investigator, and references
Principal Investigator: Joyce Silva, MD
Lead Sponsor: EMS