A Study to Assess the Burden of Herpes Zoster and Postherpetic Neuralgia in Japanese Adults Aged Sixty Years and Above
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01873365 |
Recruitment Status
:
Completed
First Posted
: June 10, 2013
Last Update Posted
: January 18, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Herpes Zoster | Other: Data collection |
Study Type : | Observational |
Actual Enrollment : | 448 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Physician-practice Based Cohort Study to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Japan |
Study Start Date : | June 2013 |
Actual Primary Completion Date : | February 2015 |
Actual Study Completion Date : | February 2015 |

Group/Cohort | Intervention/treatment |
---|---|
Prospective Group
Japanese adults, aged greater than or equal to sixty years, diagnosed with HZ.
|
Other: Data collection
Case report forms (CRFs), logbooks and booklets.
|
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 60 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
- 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.
Exclusion Criteria:
• Not applicable.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873365
Japan | |
GSK Investigational Site | |
Hokkaido, Japan, 084-0906 | |
GSK Investigational Site | |
Hokkaido, Japan, 084-0909 | |
GSK Investigational Site | |
Hokkaido, Japan, 084-0912 | |
GSK Investigational Site | |
Hokkaido, Japan, 085-0014 | |
GSK Investigational Site | |
Hokkaido, Japan, 085-0032 | |
GSK Investigational Site | |
Hokkaido, Japan, 085-0036 | |
GSK Investigational Site | |
Hokkaido, Japan, 085-0052 | |
GSK Investigational Site | |
Hokkaido, Japan, 085-0057 | |
GSK Investigational Site | |
Hokkaido, Japan, 085-0062 | |
GSK Investigational Site | |
Hokkaido, Japan, 085-0063 | |
GSK Investigational Site | |
Hokkaido, Japan, 085-0805 | |
GSK Investigational Site | |
Hokkaido, Japan, 085-0813 | |
GSK Investigational Site | |
Hokkaido, Japan, 085-0822 | |
GSK Investigational Site | |
Hokkaido, Japan, 085-8533 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01873365 History of Changes |
Other Study ID Numbers: |
200089 |
First Posted: | June 10, 2013 Key Record Dates |
Last Update Posted: | January 18, 2017 |
Last Verified: | January 2017 |
Keywords provided by GlaxoSmithKline:
Quality of life Herpes zoster Postherpetic neuralgia Japan |
Physician-practice Adults Health economics |
Additional relevant MeSH terms:
Neuralgia Herpes Zoster Neuralgia, Postherpetic Pain Neurologic Manifestations Nervous System Diseases |
Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Herpesviridae Infections DNA Virus Infections Virus Diseases |