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
For more infomation visit Clinicaltrials.gov
Study Start
June 2007
Eligibility & Criteria
- Ages Eligible for Study: 18 Years and older
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: No
Inclusion Criteria:
- History of genital HSV documented by laboratory testing at screening
- 4 or more episodes of genital herpes during the past 12 months
Exclusion Criteria:
- Subject is immunocompromised
Total Enrolment
Estimated to be 650
Contact Details
Please refer to this study by its ClinicalTrials.gov identifier: NCT00486200
Contact:
Astellas Pharma US Medical Information
Phone number: 800-727-7003
Email: clintrials.info@us.astellas.com
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