A Study to Assess the Burden of Herpes Zoster and Postherpetic Neuralgia in Japanese Adults Aged Sixty Years and Above
Completed
- Conditions
- Herpes Zoster
- Interventions
- Other: Data collection
- Registration Number
- NCT01873365
- Lead Sponsor
- GlaxoSmithKline
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 448
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prospective Group Data collection Japanese adults, aged greater than or equal to sixty years, diagnosed with HZ.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Occurrence of HZ-associated hospitalisations. 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 Occurrence of HZ-associated any pain, persisting between 0 and 270 days after the initial visit for this study. Day 0 - Day 270 Direct medical, direct non-medical and indirect costs related to PHN. Day 90 - Day 270 QoL assessment in PHN subjects. Day 90 - Day 270 Anamnestic information, clinical parameters and complications related to HZ. Day 0 - 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
Trial Locations
- Locations (1)
GSK Investigational Site
🇯🇵Hokkaido, Japan