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

GSK study ID
200089
See study documents
Clinicaltrials.gov ID
NCT01873365
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2015-04-02
    Observational study model:
    Cohort
    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:

      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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Hokkaido, Japan, 084-0906
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hokkaido, Japan, 084-0909
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hokkaido, Japan, 084-0912
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hokkaido, Japan, 085-0014
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hokkaido, Japan, 085-0032
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hokkaido, Japan, 085-0036
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 14 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website