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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01873365
First received: June 6, 2013
Last updated: June 26, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Herpes Zoster
Other: Data collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physician-practice Based Cohort Study to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Japan

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
  • Occurrence of HZ-associated PHN pain, persisting between 90 and 270 days after the initial visit for this study. [ Time Frame: Day 90 - Day 270 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of HZ-associated hospitalisations. [ Time Frame: Day 0 - Day 270 ] [ Designated as safety issue: No ]
  • Occurrence of HZ-associated any pain, persisting between 0 and 270 days after the initial visit for this study. [ Time Frame: Day 0 - Day 270 ] [ Designated as safety issue: No ]
  • Anamnestic information, clinical parameters and complications related to HZ. [ Time Frame: Day 0 - Day 270 ] [ Designated as safety issue: No ]
  • Direct medical, direct non-medical and indirect costs related to HZ. [ Time Frame: Day 0 - Day 90 ] [ Designated as safety issue: No ]
  • Quality of life (QoL) assessment in HZ subjects. [ Time Frame: Day 0 - Day 90 ] [ Designated as safety issue: No ]
  • Direct medical, direct non-medical and indirect costs related to PHN. [ Time Frame: Day 90 - Day 270 ] [ Designated as safety issue: No ]
  • QoL assessment in PHN subjects. [ Time Frame: Day 90 - Day 270 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Day 0 - Day 270 ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: July 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Prospective Group
Japanese adults, aged greater than or equal to sixty years, diagnosed with HZ.
Other: Data collection
Case report forms (CRFs), logbooks and booklets.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01873365

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Japan
GSK Investigational Site Recruiting
Hokkaido, Japan, 085-0032
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Hokkaido, Japan, 085-0014
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Hokkaido, Japan, 085-0805
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Hokkaido, Japan, 085-0057
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Hokkaido, Japan, 084-0909
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Hokkaido, Japan, 084-0906
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Hokkaido, Japan, 085-0822
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01873365     History of Changes
Other Study ID Numbers: 200089
Study First Received: June 6, 2013
Last Updated: June 26, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Quality of life
Herpes zoster
Postherpetic neuralgia
Japan
Physician-practice
Adults
Health economics

Additional relevant MeSH terms:
Herpes Zoster
Neuralgia
Neuralgia, Postherpetic
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014