A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes
A study of ASP2151 in subjects with recurrent outbreaks of genital herpes...
Brief Summary
Official Title: “A Phase II, Dose-Finding Study With ASP2151 in Subjects With Recurrent Episodes of Genital HErpes”
A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: August 2008
Intervention(s) in this Clinical Trial
- Drug: ASP2151
- Oral administration.
- Drug: valacyclovir
- Oral administration of active comparator.
- Drug: Placebo
- Oral administration of placebo.
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Placebo Comparator: 2
- Experimental: 3
- Dosing regimen 1
- Experimental: 4
- Dosing regimen 2
- Experimental: 5
- Dosing regimen 3
- Experimental: 6
- Dosing regimen 4
Outcome Measures for this Clinical Trial
Primary Measures
- To compare the efficacy and safety of ASP2151 with valacyclovir and placebo in the acute treatment of recurrent genital Herpes Simplex Virus Infection
- Time Frame: 17 days
Safety Issue?: No
- Time Frame: 17 days
Secondary Measures
- Pharmacokinetics in study patients
- Time Frame: 4 days
Safety Issue?: No
- Time Frame: 4 days
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Astellas Pharma Inc Industry
Overall Clinical Trial Officials and Contacts
Use Central Contact Study Director Astellas Pharma US, Inc.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00486200
Study ID Number: 15L-CL-101
ClinicalTrials.gov Identifier: NCT00486200
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00486200
