A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00486200
First received: June 12, 2007
Last updated: February 27, 2013
Last verified: February 2013
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Purpose
A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.
| Condition | Intervention | Phase |
|---|---|---|
|
Herpes Genitalis |
Drug: ASP2151 Drug: valacyclovir Drug: Placebo |
Phase 2 |
| 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 |
| Official Title: | A Phase II, Dose-Finding Study With ASP2151 in Subjects With Recurrent Episodes of Genital HErpes |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
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 [ Time Frame: 17 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacokinetics in study patients [ Time Frame: 4 days ] [ Designated as safety issue: No ]
| Enrollment: | 695 |
| Study Start Date: | June 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: valacyclovir
Oral administration of active comparator.
|
| Placebo Comparator: 2 |
Drug: Placebo
Oral administration of placebo.
|
|
Experimental: 3
Dosing regimen 1
|
Drug: ASP2151
Oral administration.
|
|
Experimental: 4
Dosing regimen 2
|
Drug: ASP2151
Oral administration.
|
|
Experimental: 5
Dosing regimen 3
|
Drug: ASP2151
Oral administration.
|
|
Experimental: 6
Dosing regimen 4
|
Drug: ASP2151
Oral administration.
|
Eligibility| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00486200
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Hide Study LocationsLocations
| United States, Alabama | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Phoenix, Arizona, United States, 85015 | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Los Angeles, California, United States, 90017 | |
| Sacramento, California, United States, 95821 | |
| San Diego, California, United States, 92108 | |
| Westlake Village, California, United States, 91361 | |
| United States, Colorado | |
| Denver, Colorado, United States, 80262 | |
| United States, Florida | |
| Boynton Beach, Florida, United States, 33472 | |
| Miami, Florida, United States, 33156 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30328 | |
| United States, Indiana | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Kentucky | |
| Madisonville, Kentucky, United States, 42431 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Montana | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| Omaha, Nebraska, United States, 68134 | |
| United States, New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19103 | |
| United States, Texas | |
| Arlington, Texas, United States, 76011 | |
| Houston, Texas, United States, 77058 | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Virginia | |
| Annandale, Virginia, United States, 22003 | |
| United States, Washington | |
| Seattle, Washington, United States, 98122 | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Director: | Use Central Contact | Astellas Pharma US, Inc. |
More Information
Additional Information:
Publications:
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00486200 History of Changes |
| Other Study ID Numbers: | 15L-CL-101 |
| Study First Received: | June 12, 2007 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Astellas Pharma Inc:
|
Herpes Genitalis Herpes Simplex Virus Genital Infection Genital Herpes |
ASP2151 Treatment Outcome Sexually Transmitted Disease |
Additional relevant MeSH terms:
|
Herpes Genitalis Herpes Simplex Herpesviridae Infections DNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Genital Diseases, Male Genital Diseases, Female Valacyclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013