Trial · NCT01959841
Phase III Study of ASP2151 in Herpes Zoster Patients
NCT01959841, Phase 3, Completed, Maruho Co., Ltd.; results first posted 2018-10-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase III Study of ASP2151 in Herpes Zoster Patients. Trials, record NCT01959841. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01959841
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Study of ASP2151 in Herpes Zoster Patients
- NCT number
- NCT01959841
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 751 participants, actual
- Lead sponsor
- Maruho Co., Ltd.
- Conditions
- Herpes Zoster
- Interventions
- ASP2151, valaciclovir
- First posted
- 2013-10-10
- Last updated
- 2018-11-27
- Results first posted
- 2018-10-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment | 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 | Time to Cessation of New Lesion Formation | 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. |
| Secondary | Time to Complete Crusting | 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. |
| Secondary | Time to Healing | 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 |
| Secondary | Time to Pain Resolution | 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. |
| Secondary | Time to Virus Disappearance | 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 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment | 4days | 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. | percentage of Participants | NUMBER |
| SECONDARY | Time to Cessation of New Lesion Formation | 29days | 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. | days | MEDIAN |
| SECONDARY | Time to Complete Crusting | 29days | 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. | days | MEDIAN |
| SECONDARY | Time to Healing | 29days | 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. | days | MEDIAN |
| SECONDARY | Time to Pain Resolution | 29days | 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. | days | MEDIAN |
| SECONDARY | Time to Virus Disappearance | 29days | 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. | days | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment | ASP2151(200 mg) | 69.6 | percentage of Participants | ||
| The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment | ASP2151(400mg) | 81.1 | percentage of Participants | ||
| The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment | Valaciclovir | 75.1 | percentage of Participants | ||
| Time to Cessation of New Lesion Formation | ASP2151(200 mg) | 4 | Inter-Quartile Range 3 to 5 | days | |
| Time to Cessation of New Lesion Formation | ASP2151(400mg) | 4 | Inter-Quartile Range 3 to 4 | days | |
| Time to Cessation of New Lesion Formation | Valaciclovir | 4 | Inter-Quartile Range 3 to 4 | days | |
| Time to Complete Crusting | ASP2151(200 mg) | 8 | Inter-Quartile Range 6 to 11 | days | |
| Time to Complete Crusting | ASP2151(400mg) | 9 | Inter-Quartile Range 7 to 11 | days | |
| Time to Complete Crusting | Valaciclovir | 8 | Inter-Quartile Range 7 to 11 | days | |
| Time to Healing | ASP2151(200 mg) | 11 | Inter-Quartile Range 8 to 15 | days |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ASP2151(200 mg) | 252 | |
| Overall Study | STARTED | ASP2151(400mg) | 250 | |
| Overall Study | STARTED | Valaciclovir | 249 | |
| Overall Study | Full Analysis Set Included | ASP2151(200 mg) | 247 | |
| Overall Study | Full Analysis Set Included | ASP2151(400mg) | 243 | |
| Overall Study | Full Analysis Set Included | Valaciclovir | 245 | |
| Overall Study | Full Analysis Set Excluded | ASP2151(200 mg) | 5 | |
| Overall Study | Full Analysis Set Excluded | ASP2151(400mg) | 7 | |
| Overall Study | Full Analysis Set Excluded | Valaciclovir | 4 | |
| Overall Study | Reason FAS Excluding 1 | ASP2151(200 mg) | 5 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events54
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | ASP2151(200 mg) | 1 | 252 | |
| other | Diarrhoea | Gastrointestinal disorders | ASP2151(400mg) | 2 | 249 | |
| other | Diarrhoea | Gastrointestinal disorders | Valaciclovir | 5 | 249 | |
| other | Stomatitis | Gastrointestinal disorders | ASP2151(200 mg) | 1 | 252 | |
| other | Stomatitis | Gastrointestinal disorders | ASP2151(400mg) | 7 | 249 | |
| other | Stomatitis | Gastrointestinal disorders | Valaciclovir | 0 | 249 | |
| other | Folliculitis | Infections and infestations | ASP2151(200 mg) | 5 | 252 | |
| other | Folliculitis | Infections and infestations | ASP2151(400mg) | 0 | 249 | |
| other | Folliculitis | Infections and infestations | Valaciclovir | 5 | 249 | |
| other | Nasopharyngitis | Infections and infestations | ASP2151(200 mg) | 19 | 252 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ASP2151(200 mg) | 0 | 252 |
| Total, all-cause mortality | ASP2151(400mg) | 0 | 249 |
| Total, all-cause mortality | Valaciclovir | 0 | 249 |
| Total, other adverse events | ASP2151(200 mg) | 62 | 252 |
| Total, other adverse events | ASP2151(400mg) | 64 | 249 |
| Total, other adverse events | Valaciclovir | 65 | 249 |
| Total, serious adverse events | ASP2151(200 mg) | 1 | 252 |
| Total, serious adverse events | ASP2151(400mg) | 1 | 249 |
| Total, serious adverse events | Valaciclovir | 3 | 249 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01959841
GET https://conductscience.org/api/trials/v1/NCT01959841/flow?page=2