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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Group | Japanese adults, aged greater than or equal to sixty years, diagnosed with HZ. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | Case report forms (CRFs), logbooks and booklets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 1 year | |
| Occurrence of HZ-associated PHN pain, persisting between 90 and 270 days after the initial visit for this study. | Day 90 - Day 270 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of HZ-associated hospitalisations. | Day 0 - Day 270 | |
| Occurrence of HZ-associated any pain, persisting between 0 and 270 days after the initial visit for this study. | Day 0 - Day 270 | |
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Inclusion Criteria:
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.
Exclusion Criteria:
• Not applicable.
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Japanese adults, male or female, greater than or equal to sixty years of age, presenting with HZ at the participating sites.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Hokkaido | 084-0906 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29086340 | Derived | 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. | |
| 28988331 |
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| Anamnestic information, clinical parameters and complications related to HZ. |
| Day 0 - Day 270 |
| Direct medical, direct non-medical and indirect costs related to HZ. | Day 0 - Day 90 |
| Quality of life (QoL) assessment in HZ subjects. | Day 0 - Day 90 |
| Direct medical, direct non-medical and indirect costs related to PHN. | Day 90 - Day 270 |
| QoL assessment in PHN subjects. | 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. | Day 0 - Day 270 |
| Hokkaido |
| 084-0909 |
| Japan |
| GSK Investigational Site | Hokkaido | 084-0912 | Japan |
| GSK Investigational Site | Hokkaido | 085-0014 | Japan |
| GSK Investigational Site | Hokkaido | 085-0032 | Japan |
| GSK Investigational Site | Hokkaido | 085-0036 | Japan |
| GSK Investigational Site | Hokkaido | 085-0052 | Japan |
| GSK Investigational Site | Hokkaido | 085-0057 | Japan |
| GSK Investigational Site | Hokkaido | 085-0062 | Japan |
| GSK Investigational Site | Hokkaido | 085-0063 | Japan |
| GSK Investigational Site | Hokkaido | 085-0805 | Japan |
| GSK Investigational Site | Hokkaido | 085-0813 | Japan |
| GSK Investigational Site | Hokkaido | 085-0822 | Japan |
| GSK Investigational Site | Hokkaido | 085-8533 | Japan |
| Nakamura 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. |
| 27917531 | Derived | Sato 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. |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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