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

NCT ID: NCT01327144

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2017-07-31

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

Conditions

Herpes Zoster

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Famciclovir 500mg

1 tablet each 8 hours for 7 days

Group Type: EXPERIMENTAL

Famciclovir

Intervention Type: DRUG

Famciclovir 500 mg- 1 tablet each 12 hours for 7 days

Aciclovir 400mg

2 tablets of Aciclovir 400 mg each 4 hours for 7 days

Group Type: ACTIVE_COMPARATOR

Aciclovir

Intervention Type: DRUG

Aciclovir 400 mg- 02 tablets each 4 hours for 7 days

Interventions

Famciclovir

Famciclovir 500 mg- 1 tablet each 12 hours for 7 days

Intervention Type: DRUG

Aciclovir

Aciclovir 400 mg- 02 tablets each 4 hours for 7 days

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joyce Silva, MD

Role: STUDY_DIRECTOR

EMS

Locations

Centro de Medicina Reprodutiva Dr Carlos Isaia Filho

Porto Alegre, Rio Grande do Sul, Brazil

Loema

Campinas, São Paulo, Brazil

Allergisa

Campinas, São Paulo, Brazil

CECIP Centro de Estudos Clínicos do Interior Paulista

Jaú, São Paulo, Brazil

Afip - Associacao Fundo de Incentivo A Pesquisa

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 29746903 (View on PubMed)

Other Identifiers

F500EMS1010

Identifier Type: -

Identifier Source: org_study_id