Last updated: 06/26/2019 11:00:33
A study to assess the burden of herpes zoster and postherpetic neuralgia in Japanese adults aged sixty years and above
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Physician-practice based cohort study to estimate the burden of herpes zoster and postherpetic neuralgia in Japan
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
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.
Timeframe: Approximately 1 year
Occurrence of HZ-associated PHN pain, persisting between 90 and 270 days after the initial visit for this study.
Timeframe: Day 90 - Day 270
Secondary outcomes:
Occurrence of HZ-associated hospitalisations.
Timeframe: Day 0 – Day 270
Occurrence of HZ-associated any pain, persisting between 0 and 270 days after the initial visit for this study.
Timeframe: Day 0 – Day 270
Anamnestic information, clinical parameters and complications related to HZ.
Timeframe: Day 0 – Day 270
Direct medical, direct non-medical and indirect costs related to HZ.
Timeframe: Day 0 – Day 90
Quality of life (QoL) assessment in HZ subjects.
Timeframe: Day 0 – Day 90
Direct medical, direct non-medical and indirect costs related to PHN.
Timeframe: Day 90 – Day 270
QoL assessment in PHN subjects.
Timeframe: 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.
Timeframe: Day 0 – Day 270
Interventions:
Other: Data collection
Enrollment:
448
Observational study model:
Cohort
Primary completion date:
2015-04-02
Time perspective:
Prospective
Clinical publications:
Sato K et al. (2016) 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. doi: 10.1111/1346-8138.13639.
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Not applicable
Study date(s)
June 2013 to February 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
60+ years
Accepts healthy volunteers
No
- 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.
- Not applicable.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Exclusion criteria:
Not applicable.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2015-04-02
Actual study completion date
2015-04-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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