Clinical trial NCT01873365: A Study to Assess the Burden of Herpes Zoster and Postherpetic Neuralgia in Japanese Adults Aged Sixty Years and Above
Official title: Physician-practice Based Cohort Study to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Herpes Zoster
Keywords: Quality of life
Herpes zoster
Postherpetic neuralgia
Japan
Physician-practice
Adults
Health economics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-06-10
Enrollment: 448
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Japanese adults, male or female, greater than or equal to sixty years of age, presenting with HZ at the participating sites.

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.


Eligibility 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.

Primary outcomes:
measure: 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
measure: 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:
measure: Occurrence of HZ-associated hospitalisations.
timeFrame: Day 0 - Day 270
measure: Occurrence of HZ-associated any pain, persisting between 0 and 270 days after the initial visit for this study.
timeFrame: Day 0 - Day 270
measure: Anamnestic information, clinical parameters and complications related to HZ.
timeFrame: Day 0 - Day 270
measure: Direct medical, direct non-medical and indirect costs related to HZ.
timeFrame: Day 0 - Day 90
measure: Quality of life (QoL) assessment in HZ subjects.
timeFrame: Day 0 - Day 90
measure: Direct medical, direct non-medical and indirect costs related to PHN.
timeFrame: Day 90 - Day 270
measure: QoL assessment in PHN subjects.
timeFrame: Day 90 - Day 270
measure: 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
Other outcomes:
Locations:
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.