CompletedPhase 3

Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes

Brazil150 participantsStarted 2012-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation

Timeframe: Day 5

Trial details

NCT IDNCT01281007

SponsorEMS

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-01

Results submitted2015-05-29

View on ClinicalTrials.gov More GENITAL HERPES trials