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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP2151(200 mg) | Experimental | once daily |
|
| ASP2151(400mg) | Experimental | once daily |
|
| valaciclovir | Experimental | 1000 mg three times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP2151 | Drug | 200 mg once daily or 400 mg once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment | 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. | 4days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Cessation of New Lesion Formation | 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. | 29days |
| Time to Complete Crusting |
Not provided
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:
Patients who are not expected to have an adequate response to oral antiviral medication
An extreme decline in immune function
Presence of serious complications
Patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent:
Current or previous history of malignant tumor within 5 years before informed consent
Diagnosis of autoimmune disease
Evidence of bone marrow suppression
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| Name | Affiliation | Role |
|---|---|---|
| Maruho Co.,Ltd. Kyoto R&D Center | Clinical Development Department | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapporo | Hokkaido | Japan | ||||
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The study was conducted at 106 sites in Japan from September 2013 to Jully 2015
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| ID | Title | Description |
|---|---|---|
| FG000 | ASP2151(200 mg) | once daily ASP2151: 200 mg once daily or 400 mg once daily |
| FG001 | ASP2151(400mg) | once daily ASP2151: 200 mg once daily or 400 mg once daily |
| FG002 | Valaciclovir | 1000 mg three times daily valaciclovir: 1000 mg three times daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The full analysis set(FAS).The FAS was defined as patients who were diagnosed with herpes zoster at the time of case registration, who subsequently received the study drugs, and had any efficacy variable measured.
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| ID | Title | Description |
|---|---|---|
| BG000 | ASP2151(200 mg) | once daily ASP2151: 200 mg once daily or 400 mg once daily |
| BG001 | ASP2151(400mg) | once daily ASP2151: 200 mg once daily or 400 mg once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment | 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. | The full analysis set(FAS).The FAS was defined as patients who were diagnosed with herpes zoster at the time of case registration, who subsequently received the study drugs, and had any efficacy variable measured. | Posted | Number | percentage of Participants | 4days |
|
92 days
Participant who has not received any study drug after randomization excluded from the Number participants at Risk
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ASP2151(200 mg) | once daily ASP2151: 200 mg once daily or 400 mg once daily | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| linical Development Dept. | Maruho Co.,Ltd. Kyoto R&D Center | +81-75-325-3255 | ctinfo@mii.maruho.co.jp |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C568714 | ASP2151 |
| D000077483 | Valacyclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 |
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| valaciclovir |
| Drug |
1000 mg three times daily |
|
We defined the following state as "Complete crusting".
|
| 29days |
| Time to Healing | We defined the following state as "Healing".
| 29days |
| Time to Pain Resolution | 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. | 29days |
| Time to Virus Disappearance | 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 | 29days |
| Yokohama |
| Kanagawa |
| Japan |
| Nakano-Ku | Tokyo | Japan |
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Clinical laboratory value |
|
| Platelet count below on day1 or 4 |
|
| BG002 | Valaciclovir | 1000 mg three times daily valaciclovir: 1000 mg three times daily |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Time from onset of rash to the first dose | Count of Participants | Participants |
|
once daily
ASP2151: 200 mg once daily or 400 mg once daily
| OG002 | Valaciclovir | 1000 mg three times daily valaciclovir: 1000 mg three times daily |
|
|
|
| Secondary | Time to Cessation of New Lesion Formation | 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. | The full analysis set(FAS).The FAS was defined as patients who were diagnosed with herpes zoster at the time of case registration, who subsequently received the study drugs, and had any efficacy variable measured. | Posted | Median | Inter-Quartile Range | days | 29days |
|
|
|
| Secondary | Time to Complete Crusting | We defined the following state as "Complete crusting".
| The full analysis set(FAS).The FAS was defined as patients who were diagnosed with herpes zoster at the time of case registration, who subsequently received the study drugs, and had any efficacy variable measured. | Posted | Median | Inter-Quartile Range | days | 29days |
|
|
|
| Secondary | Time to Healing | We defined the following state as "Healing".
| The full analysis set(FAS).The FAS was defined as patients who were diagnosed with herpes zoster at the time of case registration, who subsequently received the study drugs, and had any efficacy variable measured. | Posted | Median | Inter-Quartile Range | days | 29days |
|
|
|
| Secondary | Time to Pain Resolution | 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. | The full analysis set(FAS).The FAS was defined as patients who were diagnosed with herpes zoster at the time of case registration, who subsequently received the study drugs, and had any efficacy variable measured. | Posted | Median | Inter-Quartile Range | days | 29days |
|
|
|
| Secondary | Time to Virus Disappearance | 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 | The full analysis set(FAS).The FAS was defined as patients who were diagnosed with herpes zoster at the time of case registration, who subsequently received the study drugs, and had any efficacy variable measured. | Posted | Median | Inter-Quartile Range | days | 29days |
|
|
|
| 252 |
| 1 |
| 252 |
| 62 |
| 252 |
| EG001 | ASP2151(400mg) | once daily ASP2151: 200 mg once daily or 400 mg once daily | 0 | 249 | 1 | 249 | 64 | 249 |
| EG002 | Valaciclovir | 1000 mg three times daily valaciclovir: 1000 mg three times daily | 0 | 249 | 3 | 249 | 65 | 249 |
| Infectious mononucleosis | Infections and infestations | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Embolic cerebral infarction | Nervous system disorders | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Beta-N-acetyl-D-glucosaminidase increased | Investigations | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Fibrin degradation products increased | Investigations | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Protein urine present | Investigations | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Alpha 1 microglobulin increased | Investigations | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
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| D007239 | Infections |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |