Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase III Study of ASP2151 in Herpes Simplex Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01959295
Recruitment Status : Completed
First Posted : October 10, 2013
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Maruho Co., Ltd.

Brief Summary:
To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.

Condition or disease Intervention/treatment Phase
Herpes Simplex Drug: ASP2151 Drug: ASP2151 placebo Phase 3

Detailed Description:
A double-blind, randomized, placebo-controlled, parallel-group study will be conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (labial/facial herpes or recurrent genital herpes). The efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving lesion healing by Day 8 of study treatment" to demonstrate the superiority of ASP2151 to placebo. The safety will be evaluated based on adverse events, laboratory tests, vital signs, and ECGs.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 453 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase III Study of ASP2151 in Herpes Simplex Patients ― A Double-blind, Placebo-controlled Study ―
Study Start Date : August 2013
Actual Primary Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herpes Simplex

Arm Intervention/treatment
Experimental: ASP2151 Drug: ASP2151
200 mg once daily

Placebo Comparator: ASP2151 placebo Drug: ASP2151 placebo
once daily




Primary Outcome Measures :
  1. The proportion of subjects achieving lesion healing by Day 8 of study treatment [ Time Frame: 8days ]

Secondary Outcome Measures :
  1. Time to healing [ Time Frame: 29days ]
  2. Time to complete crusting [ Time Frame: 29days ]
  3. Time to virus disappearance [ Time Frame: 29days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with a rash associated with moderate or severe herpes simplex, for which oral antiviral medication is indicated

    • Labial/facial herpes: Patients with at least 10 papulae or vesicles/pustules
    • Recurrent genital herpes: Patients with at least 5 papulae or vesicles/pustules on the genital organs or in the genital and circumanal region
  2. Patients who can start receiving the study drug within 48 hours after onset of rash
  3. Age: 20 years or older, but younger than 80 years

Exclusion Criteria:

  1. Patients who are not expected to have an adequate response to oral antiviral medication
  2. An extreme decline in immune function
  3. Presence of serious complications
  4. Patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent:

    • AST or ALT ≥ 2.5 x upper limit of normal
    • Platelet count < lower limit of normal
    • Serum creatinine ≥ 1.5 mg/dL
    • Creatinine clearance < 30 mL/min
  5. Current or previous history of malignant tumor within 5 years before informed consent
  6. Diagnosis of autoimmune disease
  7. Evidence of bone marrow suppression

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01959295


Locations
Layout table for location information
Japan
Sapporo, Hokkaido, Japan
Yokohama, Kanagawa, Japan
Nakano-ku, Tokyo, Japan
Sponsors and Collaborators
Maruho Co., Ltd.

Layout table for additonal information
Responsible Party: Maruho Co., Ltd.
ClinicalTrials.gov Identifier: NCT01959295     History of Changes
Other Study ID Numbers: M522101-J11
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases