Herpes ZosterPhase 2NCT00487682
Dose-finding Study of ASP2151 in Subjects With Herpes Zoster
A Phase 2 study testing ASP2151 and Valacyclovir hydrochloride in people with Herpes Zoster, run by Astellas Pharma Inc at 5 sites in Japan.
Trial summary
To investigate the efficacy and safety of three different doses of ASP2151, as compared to valacyclovir hydrochloride in subjects with herpes zoster, and to determine the recommended clinical dose. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- ASP2151 and Valacyclovir hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 403 participants
- Where
- 5 sitesJapan
- Study dates
- 13 Nov 2007to 1 Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged from 20 years to under 80 years on the day informed consent is obtained
- Subjects to whom the study drugs can be orally administered within 72 hours after the onset of rash due to herpes zoster
- Subjects in whom protocol-specified observations and assessments are considered possible
Who cannot join
- Subjects with extremely compromised immune function due to underlying diseases, treatment with Immunosuppressive agents etc., or radiotherapy
- Subjects with a serious underlying disease that corresponds to Grade 3 in the Classification Criteria for teh Seriousness of Adverse Drug Reactions
- Subjects with concurrent malignant tumors, or those with a history of malignant tumors within the past 5 years
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Study site
Chūbu
Study site
Hokkaido
Study site
Kanto
Study site
Kinki
Study site
Kyusyu
About this study
Official title: Dose-finding Study of ASP2151 in Subjects With Herpes Zoster- A Multicenter, Randomized, Double-blind, Valacyclovir Hydrochloride-controlled, Parallel-group, Comparative Study
To investigate the efficacy and safety of three different doses of ASP2151, as compared to valacyclovir hydrochloride in subjects with herpes zoster, and to determine the recommended clinical dose.
- Conditions
- Herpes Zoster
- Being tested
- ASP2151, Valacyclovir hydrochloride
- Keywords
- Valacyclovir hydrochloride, herpes zoster, ASP2151
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP2151Drug
oral
Valacyclovir hydrochlorideDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ASP2151 low dose Receives: Drug: ASP2151 |
| 2 | Experimental | ASP2151 middle dose Receives: Drug: ASP2151 |
| 3 | Experimental | ASP2151 high dose Receives: Drug: ASP2151 |
| 4 | Active comparator | Valacyclovir hydrochloride Receives: Drug: Valacyclovir hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster
Measured: 3 months
Secondary outcomes (1)
Improvement of cutaneous symptoms and pain
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study start13 Nov 2007
- Primary completion1 Sep 2008
- Study completion1 Sep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487682
- Sponsor's protocol ID
- 15L-CL-221
- Status last verified
- Nov 2018
- First submitted
- 15 Jun 2007
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-finding Study of ASP2151 in Subjects With Herpes Zoster- A Multicenter, Randomized, Double-blind, Valacyclovir Hydrochloride-controlled, Parallel-group, Comparative Study
- ClinicalTrials.gov ID
- NCT00487682
- Acronym / sponsor ID
- 15L-CL-221
- Conditions
- Herpes Zoster
- Keywords
- Valacyclovir hydrochloride, herpes zoster, ASP2151
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2007 (actual)
- Primary completion
- 1 Sep 2008 (actual)
- Study completion
- 1 Sep 2008 (actual)
- First posted
- 18 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the efficacy and safety of three different doses of ASP2151, as compared to valacyclovir hydrochloride in subjects with herpes zoster, and to determine the recommended clinical dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ASP2151ASP2151 low dose |
| 2 | Experimental | Drug: ASP2151ASP2151 middle dose |
| 3 | Experimental | Drug: ASP2151ASP2151 high dose |
| 4 | Active comparator | Drug: Valacyclovir hydrochlorideValacyclovir hydrochloride |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects aged from 20 years to under 80 years on the day informed consent is obtained
- Subjects to whom the study drugs can be orally administered within 72 hours after the onset of rash due to herpes zoster
- Subjects in whom protocol-specified observations and assessments are considered possible
Key exclusion criteria (3 listed)
- Subjects with extremely compromised immune function due to underlying diseases, treatment with Immunosuppressive agents etc., or radiotherapy
- Subjects with a serious underlying disease that corresponds to Grade 3 in the Classification Criteria for teh Seriousness of Adverse Drug Reactions
- Subjects with concurrent malignant tumors, or those with a history of malignant tumors within the past 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP2151oral | Drug | 1, 2, 3 |
| Valacyclovir hydrochlorideoral | Drug | 4 |
Primary outcome
To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster
Time frame: 3 months
1 secondary outcome
Improvement of cutaneous symptoms and pain
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Related trials for Herpes Zoster
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Use Central Contact study chair
Astellas Pharma Inc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP2151 and Valacyclovir hydrochloride in people with Herpes Zoster, run by Astellas Pharma Inc at 5 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018.