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Phase III Study of ASP2151 in Herpes Zoster 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: NCT01959841
Recruitment Status : Completed
First Posted : October 10, 2013
Results First Posted : October 18, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Maruho Co., Ltd.

Brief Summary:
To evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster.

Condition or disease Intervention/treatment Phase
Herpes Zoster Drug: ASP2151 Drug: valaciclovir Phase 3

Detailed Description:
A double-blind, randomized, parallel-group study will be conducted to evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster. The efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving cessation of new lesion formation by Day 4 of study treatment" to demonstrate the non-inferiority of ASP2151 to VACV. The safety will be evaluated based on adverse events, laboratory tests, vital signs, and ECGs.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 751 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase III Study of ASP2151 in Herpes Zoster Patients― A Double-blind, Valaciclovir-controlled Study
Study Start Date : August 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 10, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: ASP2151(200 mg)
once daily
Drug: ASP2151
200 mg once daily or 400 mg once daily

Experimental: ASP2151(400mg)
once daily
Drug: ASP2151
200 mg once daily or 400 mg once daily

Experimental: valaciclovir
1000 mg three times daily
Drug: valaciclovir
1000 mg three times daily




Primary Outcome Measures :
  1. The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment [ Time Frame: 4days ]
    The investigator assessed the Number of rashes (erythemas/papulae and vesicles/pustules). The "new lesion formation" was defined as the state in which the number of rashes is increasing.


Secondary Outcome Measures :
  1. Time to Cessation of New Lesion Formation [ Time Frame: 29days ]
    The investigator assessed the Number of rashes (erythemas/papulae and vesicles/pustules). The "new lesion formation" was defined as the state in which the number of rashes is increasing.

  2. Time to Complete Crusting [ Time Frame: 29days ]

    We defined the following state as "Complete crusting".

    1. A condition where all lesions of erythemas/papulae, vesicles/pustules, and erosions/ulcers have disappeared, and all rashes are crusted (epithelialization of the base of crusts is not required).
    2. In subjects with no formation of vesicles or pustules, a condition where all lesions of erythemas/papulae have disappeared.

  3. Time to Healing [ Time Frame: 29days ]

    We defined the following state as "Healing".

    1. A condition where all lesions of erythemas/papulae, vesicles/pustules, and erosions/ulcers have disappeared, and complete disappearance of crusts or complete epithelialization of the base of crusts are considered to have been achieved.
    2. In subjects with no formation of vesicles or pustules, a condition where all lesions of erythemas/papulae have disappeared

  4. Time to Pain Resolution [ Time Frame: 29days ]
    Investigators assessed the pain using NRS. The date of pain resolution is defined as the first day when all NRS scores are rated as 2 or less, and such scores are continuously observed until Day 92 or discontinuation visit.

  5. Time to Virus Disappearance [ Time Frame: 29days ]
    Virus desiappearance was defined as the participants who who reached virus-negative status according to the virus isolation and culture assay or whose samples were not available because of complete crusting or healing



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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 who have a rash associated with herpes zoster, and who can start receiving the study drug within 72 hours after onset of the rash

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 < 50 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): NCT01959841


Locations
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Japan
Sapporo, Hokkaido, Japan
Yokohama, Kanagawa, Japan
Nakano-Ku, Tokyo, Japan
Sponsors and Collaborators
Maruho Co., Ltd.
Investigators
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Study Director: Maruho Co.,Ltd. Kyoto R&D Center Clinical Development Department

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Responsible Party: Maruho Co., Ltd.
ClinicalTrials.gov Identifier: NCT01959841     History of Changes
Other Study ID Numbers: M522101-J01
First Posted: October 10, 2013    Key Record Dates
Results First Posted: October 18, 2018
Last Update Posted: November 27, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valacyclovir
Antiviral Agents
Anti-Infective Agents