Clinical trial NCT01327144: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2011-04-01
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: For efficacy evaluation, a visual analogue scale (VAS) will be used to detect the improvement of symptoms
timeFrame: day 7
Secondary outcomes:
measure: Safety will be evaluated by the adverse events occurrences
timeFrame: day 7
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Centro de Medicina Reprodutiva Dr Carlos Isaia Filho
state: RS
city: Campinas
country: Brazil
facility: Loema
state: SP
city: Jau
country: Brazil
facility: CECIP Centro de Estudos Clínicos do Interior Paulista
state: SP
city: Sao Paulo
country: Brazil
facility: Afip - Associacao Fundo de Incentivo A Pesquisa
state: SP
city: Campinas
country: Brazil
facility: Allergisa
state: São Paulo
Study officials:
affiliation: EMS
name: Joyce Silva, MD
role: STUDY_DIRECTOR
References:
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.