Efficacy of Oral Famciclovir Versus Aciclovir Treatment in Patients With Herpes Zoster
Information source: EMS
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Zoster
Intervention: Famciclovir (Drug); Aciclovir (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: EMS Official(s) and/or principal investigator(s):
Felipe Pinho, MD, Study Director, Affiliation: EMS
Overall contact:
Priscila Russo, M.Sc, Phone: 55 11 38879851, Email: priscila.russo@ems.com.br
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Detailed description:
Study Design
- Open-label, prospective, parallel group, intent to treat trial
- Experiment duration: 7 days
- 2 visits (days 0, and 7)
- Reduction symptoms
- Adverse events evaluation
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
Priscila Russo, M.Sc, Phone: 55 11 38879851, Email: priscila.russo@ems.com.br
Faculdade de Medicina do ABC, São Paulo, Brazil; Not yet recruiting
Carlos Machado, MD
Carlos Machado, MD, Principal Investigator
Additional Information
Starting date: July 2011
Last updated: March 31, 2011
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