Phase 3
N=150
Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
GENITAL HERPES
Bottom Line
View on ClinicalTrials.gov: NCT01281007 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation — 73; 52 subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Famciclovir (Drug); Aciclovir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- EMS
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation |
73; 52 | — |
| SECONDARY Safety Will be Evaluated by the Adverse Events Occurence |
— | — |
Summary
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT01281007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.