A Study to Assess the Burden of Herpes Zoster and Postherpetic Neuralgia in Japanese Adults Aged Sixty Years and Above

NCT01873365 | Completed

• 1 other identifier: 200089
• Study Type: observational
• Target: 448
• Locations: 1 country
• Sites: 14

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.

Conditions

Herpes Zoster

Keywords

Quality of life; Herpes zoster; Postherpetic neuralgia; Japan; Physician-practice; Adults; Health economics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Occurrence of HZ-associated hospitalisations.

  Day 0 - Day 270

• Occurrence of HZ-associated any pain, persisting between 0 and 270 days after the initial visit for this study.

  Day 0 - Day 270

• Anamnestic information, clinical parameters and complications related to HZ.

  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

Study Arms (1)

Prospective Group

Japanese adults, aged greater than or equal to sixty years, diagnosed with HZ.

Other: Data collection

Interventions

Data collection OTHER

Case report forms (CRFs), logbooks and booklets.

Prospective Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Not applicable.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (14)

GSK Investigational Site

Hokkaido, 084-0906, Japan

Location

GSK Investigational Site

Hokkaido, 084-0909, Japan

Location

GSK Investigational Site

Hokkaido, 084-0912, Japan

Location

GSK Investigational Site

Hokkaido, 085-0014, Japan

Location

GSK Investigational Site

Hokkaido, 085-0032, Japan

Location

GSK Investigational Site

Hokkaido, 085-0036, Japan

Location

GSK Investigational Site

Hokkaido, 085-0052, Japan

Location

GSK Investigational Site

Hokkaido, 085-0057, Japan

Location

GSK Investigational Site

Hokkaido, 085-0062, Japan

Location

GSK Investigational Site

Hokkaido, 085-0063, Japan

Location

GSK Investigational Site

Hokkaido, 085-0805, Japan

Location

GSK Investigational Site

Hokkaido, 085-0813, Japan

Location

GSK Investigational Site

Hokkaido, 085-0822, Japan

Location

GSK Investigational Site

Hokkaido, 085-8533, Japan

Location

Related Publications (3)

• 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.

  PMID: 29086340 DERIVED

• 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.

  PMID: 28988331 DERIVED

• 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.

  PMID: 27917531 DERIVED

MeSH Terms

Conditions

Herpes Zoster; Neuralgia, Postherpetic

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 10, 2013
• Study Start: June 29, 2013
• Primary Completion: February 4, 2015
• Study Completion: February 4, 2015
• Last Updated: June 1, 2018

Record last verified: 2018-05

Locations

JP (14)