Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
This study has been completed.
Sponsor:
EMS
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01281007
First received: January 20, 2011
Last updated: July 3, 2015
Last verified: July 2015
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Purpose
Recurrent genital herpes is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are effective oral prescription antiviral medicines available to reduce the discomfort of symptoms, such as famciclovir and aciclovir.
This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy and safety of treatment with famciclovir (125 mg) versus aciclovir (200 mg) in patients with active recurrent genital herpes.
| Condition | Intervention | Phase |
|---|---|---|
|
GENITAL HERPES |
Drug: Famciclovir Drug: Aciclovir |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Famciclovir 125 mg Comparing to Aciclovir 200 mg in Patients With Active Recurrent Genital Herpes |
Resource links provided by NLM:
Further study details as provided by EMS:
Primary Outcome Measures:
- Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation [ Time Frame: Day 5 ] [ Designated as safety issue: No ]Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.
Secondary Outcome Measures:
- Safety Will be Evaluated by the Adverse Events Occurence [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]Adverse events will be collected and followed in order to evaluate safety and tolerability
| Enrollment: | 150 |
| Study Start Date: | July 2012 |
| Study Completion Date: | March 2015 |
| Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Famciclovir 125 mg
1 tablet every 12 hours for 5 days
|
Drug: Famciclovir
Famciclovir 125 mg every 12 hours for 5 days
|
|
Active Comparator: Aciclovir 200 mg
1 tablet every 4 hours (excluding nocturnal dose) for 5 days
|
Drug: Aciclovir
Aciclovir 200 mg every 4 hours fo 5 days
|
Detailed Description:
STUDY DESIGN
- Open-label, prospective, parallel group, intent to treat trial
- Experiment duration: 5 days
- 2 visits (days 1, and 5)
- Reduction of symptoms
- Adverse events evaluation
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Patients must be able to understand the study procedures agree to participate and give written consent.
- Patients with clinical diagnosis of recurrent genital herpes;
- Score symptoms higher than 4;
- 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281007
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281007
Locations
| Brazil | |
| Centro de Medicina Reprodutiva Dr Carlos Isaia Filho Ltda | |
| Porto Alegre, RS, Brazil | |
| Hospital de Clínicas de Porto Alegre | |
| Porto Alegre, RS, Brazil | |
| SPVita | |
| Braganca Paulista, SP, Brazil | |
| Caep Centro Avancado de Estudos E Pesquisas Ltda | |
| Campinas, SP, Brazil | |
| CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas | |
| Campinas, SP, Brazil | |
| CECIP - Centro de Estudos Clínicos do Interior Paulista | |
| Jau, SP, Brazil | |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo | |
| Ribeirao Preto, SP, Brazil, 14048900 | |
| Instituto Sirio Libanes de Ensino e Pesquisa | |
| Sao Paulo, SP, Brazil, 01308-060 | |
| Afip - Associacao Fundo de Incentivo A Psicofarmacologia | |
| Sao Paulo, SP, Brazil | |
Sponsors and Collaborators
EMS
Investigators
| Study Director: | Roberto Amazonas, MD | EMS |
More Information
| Responsible Party: | EMS |
| ClinicalTrials.gov Identifier: | NCT01281007 History of Changes |
| Other Study ID Numbers: | F125EMS1010 |
| Study First Received: | January 20, 2011 |
| Results First Received: | May 29, 2015 |
| Last Updated: | July 3, 2015 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by EMS:
|
Herpes Simplex Virus |
Additional relevant MeSH terms:
|
Herpes Genitalis Herpes Simplex Herpesviridae Infections DNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Genital Diseases, Male |
Genital Diseases, Female Acyclovir Famciclovir 2-Aminopurine Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 23, 2016