A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.
Official Title
A Phase II, Dose-Finding Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes
Conditions
- Herpes Genitalis
Study Type
Interventional
Study Design
Treatment, Randomised, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study.
Further Details
Primary Outcome Measures:
-
To compare the efficacy and safety of ASP2151 with valacyclovir and placebo in the acute treatment of recurrent genital Herpes Simplex Virus Infection
Secondary Outcome Measures:
-
Pharmacokinetics in study patients
Study Start
June 2007
Eligibility & Criteria
Official Title
A Phase II, Dose-Finding Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes
Conditions
- Herpes Genitalis
Study Type
Interventional
Study Design
Treatment, Randomised, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study.
Further Details
Primary Outcome Measures:
-
To compare the efficacy and safety of ASP2151 with valacyclovir and placebo in the acute treatment of recurrent genital Herpes Simplex Virus Infection
Secondary Outcome Measures:
-
Pharmacokinetics in study patients
Study Start
June 2007
Eligibility & Criteria
Eligibilty
- Ages Eligible for Study: 18 Years and older
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
- Subject has a history of genital HSV documented by laboratory testing at screening
- Subject has experienced 4 or more episodes of genital herpes during the past 12 months
Exclusion Criteria:
- Subject is immunocompromised
Total Enrolment
650
Contact Details
Contact: Astellas Pharma US Medical Information
Telephone: +1-800-727-7003
Email: clintrials.info@us.astellas.com
Total Enrolment
650
Contact Details
Contact: Astellas Pharma US Medical Information
Telephone: +1-800-727-7003
Email: clintrials.info@us.astellas.com
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