Herpes ZosterNCT01873365
A Study to Assess the Burden of Herpes Zoster and Postherpetic Neuralgia in Japanese Adults Aged Sixty Years and Above
An observational study of Herpes Zoster, run by GlaxoSmithKline at 14 sites in Japan.
Trial summary
The study aims to estimate the incidence of herpes zoster (HZ), proportion of postherpetic neuralgia (PHN) and the economic burden and impact on quality of life, in Japanese adults greater than or equal to sixty years of age. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Data collection
- How many people
- 448 participants
- Where
- 14 sitesJapan
- Study dates
- 29 Jun 2013to 4 Feb 2015
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Japanese adults, male or female, greater than or equal to sixty years of age, presenting with HZ at the participating sites.
Who may be able to join
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- A male or female greater than or equal to sixty years of age, presenting with HZ at the time of enrollment.
- HZ diagnosis.
- Is the subject's first outpatient diagnosis for this HZ episode. OR
- Took place up to seven days prior to the initial visit for the present study. Note: Recurrent HZ cases may be enrolled as new cases based on the investigator's clinical practice.
Who cannot join
- Not applicable.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Japan14 sites
GSK Investigational Site
Hokkaido, 084-0906
GSK Investigational Site
Hokkaido, 084-0909
GSK Investigational Site
Hokkaido, 084-0912
GSK Investigational Site
Hokkaido, 085-0014
GSK Investigational Site
Hokkaido, 085-0032
GSK Investigational Site
Hokkaido, 085-0036
GSK Investigational Site
Hokkaido, 085-0052
GSK Investigational Site
Hokkaido, 085-0057
GSK Investigational Site
Hokkaido, 085-0062
GSK Investigational Site
Hokkaido, 085-0063
GSK Investigational Site
Hokkaido, 085-0805
GSK Investigational Site
Hokkaido, 085-0813
GSK Investigational Site
Hokkaido, 085-0822
GSK Investigational Site
Hokkaido, 085-8533
About this study
Official title: Physician-practice Based Cohort Study to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Japan
The study aims to estimate the incidence of herpes zoster (HZ), proportion of postherpetic neuralgia (PHN) and the economic burden and impact on quality of life, in Japanese adults greater than or equal to sixty years of age.
- Conditions
- Herpes Zoster
- Being tested
- Data collection
- Keywords
- Quality of life, Herpes zoster, Postherpetic neuralgia, Japan, Physician-practice, Adults, Health economics
- Medical subject headings
- Herpes Zoster, Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Case report forms (CRFs), logbooks and booklets.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Group | Japanese adults, aged greater than or equal to sixty years, diagnosed with HZ. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of HZ cases reported in the study area, overall and within a specific age-group and gender. The following age-groups will be considered: 60-69, 70-79 and ≥ 80 years of age.
Measured: Approximately 1 year
Occurrence of HZ-associated PHN pain, persisting between 90 and 270 days after the initial visit for this study.
Measured: Day 90 - Day 270
Secondary outcomes (8)
Occurrence of HZ-associated hospitalisations.
Measured: Day 0 - Day 270
Occurrence of HZ-associated any pain, persisting between 0 and 270 days after the initial visit for this study.
Measured: Day 0 - Day 270
Anamnestic information, clinical parameters and complications related to HZ.
Measured: Day 0 - Day 270
Direct medical, direct non-medical and indirect costs related to HZ.
Measured: Day 0 - Day 90
Quality of life (QoL) assessment in HZ subjects.
Measured: Day 0 - Day 90
Direct medical, direct non-medical and indirect costs related to PHN.
Measured: Day 90 - Day 270
QoL assessment in PHN subjects.
Measured: Day 90 - Day 270
Impact of the following factors on the development of PHN: - age, - gender, - concomitant disease, - current immunosuppressive therapy, - HZ severity at first consultation, - timing of initiation of treatment with antiviral agent etc.
Measured: Day 0 - Day 270
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study start29 Jun 2013
- Primary completion4 Feb 2015
- Study completion4 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873365
- Sponsor's protocol ID
- 200089
- Status last verified
- May 2018
- First submitted
- 6 Jun 2013
- Last updated
- 1 Jun 2018
- Results posted
- No
Publications
Mizukami A, Sato K, Adachi K, Matthews S, Holl K, Matsuki T, Kaise T, Curran D. Impact of Herpes Zoster and Post-Herpetic Neuralgia on Health-Related Quality of Life in Japanese Adults Aged 60 Years or Older: Results from a Prospective, Observational Cohort Study. Clin Drug Investig. 2018 Jan;38(1):29-37. doi: 10.1007/s40261-017-0581-5.
PubMed 29086340Nakamura H, Mizukami A, Adachi K, Matthews S, Holl K, Asano K, Watanabe A, Adachi R, Kiuchi M, Kobayashi K, Sato K, Matsuki T, Kaise T, Curran D. Economic Burden of Herpes Zoster and Post-Herpetic Neuralgia in Adults 60 Years of Age or Older: Results from a Prospective, Physician Practice-Based Cohort Study in Kushiro, Japan. Drugs Real World Outcomes. 2017 Dec;4(4):187-198. doi: 10.1007/s40801-017-0119-4.
PubMed 28988331Sato K, Adachi K, Nakamura H, Asano K, Watanabe A, Adachi R, Kiuchi M, Kobayashi K, Matsuki T, Kaise T, Gopala K, Holl K. Burden of herpes zoster and postherpetic neuralgia in Japanese adults 60 years of age or older: Results from an observational, prospective, physician practice-based cohort study. J Dermatol. 2017 Apr;44(4):414-422. doi: 10.1111/1346-8138.13639. Epub 2016 Dec 5.
PubMed 27917531
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician-practice Based Cohort Study to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Japan
- ClinicalTrials.gov ID
- NCT01873365
- Acronym / sponsor ID
- 200089
- Conditions
- Herpes Zoster
- Keywords
- Quality of life, Herpes zoster, Postherpetic neuralgia, Japan, Physician-practice, Adults, Health economics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2013
- Primary completion
- 4 Feb 2015 (actual)
- Study completion
- 4 Feb 2015 (actual)
- First posted
- 10 Jun 2013 (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.
The study aims to estimate the incidence of herpes zoster (HZ), proportion of postherpetic neuralgia (PHN) and the economic burden and impact on quality of life, in Japanese adults greater than or equal to sixty years of age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Group | – | Other: Data collectionJapanese adults, aged greater than or equal to sixty years, diagnosed with HZ. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Japanese adults, male or female, greater than or equal to sixty years of age, presenting with HZ at the participating sites.
Key inclusion criteria (6 listed)
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- A male or female greater than or equal to sixty years of age, presenting with HZ at the time of enrollment.
- HZ diagnosis.
Key exclusion criteria (1 listed)
- Not applicable.
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 |
|---|---|---|
| Data collectionCase report forms (CRFs), logbooks and booklets. | Other | Prospective Group |
Primary outcome
Total number of HZ cases reported in the study area, overall and within a specific age-group and gender. The following age-groups will be considered: 60-69, 70-79 and ≥ 80 years of age.
Time frame: Approximately 1 year
Occurrence of HZ-associated PHN pain, persisting between 90 and 270 days after the initial visit for this study.
Time frame: Day 90 - Day 270
8 secondary outcomes
Occurrence of HZ-associated hospitalisations.
Time frame: Day 0 - Day 270
Occurrence of HZ-associated any pain, persisting between 0 and 270 days after the initial visit for this study.
Time frame: Day 0 - Day 270
Anamnestic information, clinical parameters and complications related to HZ.
Time frame: Day 0 - Day 270
Direct medical, direct non-medical and indirect costs related to HZ.
Time frame: Day 0 - Day 90
Quality of life (QoL) assessment in HZ subjects.
Time frame: Day 0 - Day 90
Direct medical, direct non-medical and indirect costs related to PHN.
Time frame: Day 90 - Day 270
QoL assessment in PHN subjects.
Time frame: Day 90 - Day 270
Impact of the following factors on the development of PHN: - age, - gender, - concomitant disease, - current immunosuppressive therapy, - HZ severity at first consultation, - timing of initiation of treatment with antiviral agent etc.
Time frame: Day 0 - Day 270
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 1 Jun 2018.
- Derived from this study: PubMed 29086340Mizukami A, Sato K, Adachi K, Matthews S, Holl K, Matsuki T, Kaise T, Curran D. Impact of Herpes Zoster and Post-Herpetic Neuralgia on Health-Related Quality of Life in Japanese Adults Aged 60 Years or Older: Results from a Prospective, Observational Cohort Study. Clin Drug Investig. 2018 Jan;38(1):29-37. doi: 10.1007/s40261-017-0581-5.
- Derived from this study: PubMed 28988331Nakamura H, Mizukami A, Adachi K, Matthews S, Holl K, Asano K, Watanabe A, Adachi R, Kiuchi M, Kobayashi K, Sato K, Matsuki T, Kaise T, Curran D. Economic Burden of Herpes Zoster and Post-Herpetic Neuralgia in Adults 60 Years of Age or Older: Results from a Prospective, Physician Practice-Based Cohort Study in Kushiro, Japan. Drugs Real World Outcomes. 2017 Dec;4(4):187-198. doi: 10.1007/s40801-017-0119-4.
- Derived from this study: PubMed 27917531Sato K, Adachi K, Nakamura H, Asano K, Watanabe A, Adachi R, Kiuchi M, Kobayashi K, Matsuki T, Kaise T, Gopala K, Holl K. Burden of herpes zoster and postherpetic neuralgia in Japanese adults 60 years of age or older: Results from an observational, prospective, physician practice-based cohort study. J Dermatol. 2017 Apr;44(4):414-422. doi: 10.1111/1346-8138.13639. Epub 2016 Dec 5.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herpes Zoster, run by GlaxoSmithKline at 14 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 6 inclusion and 1 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 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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.
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?
Total number of HZ cases reported in the study area, overall and within a specific age-group and gender. The following age-groups will be considered: 60-69, 70-79 and ≥ 80 years of age. (time frame: Approximately 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01873365, which also lists 3 linked publications.
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 1 Jun 2018.