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Study to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Spain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01521286
First Posted: January 30, 2012
Last Update Posted: September 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
The purpose of this study is to collect data on the incidence, complications and impact on quality of life of herpes zoster (HZ) disease in adults >=50 years of age in Spain. This study will also collect data on costs related to the HZ disease, especially postherpetic neuralgia (PHN)

Condition Intervention
Herpes Zoster Other: Data collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Population Based Surveillance to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Spain

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Total number of HZ cases as recorded per participating practice, overall and within a specific age group and gender. [ Time Frame: up to one year ]

Secondary Outcome Measures:
  • Occurrence of PHN, i.e. persistence of HZ-related pain. [ Time Frame: 90, 180, and 270 days after onset of HZ. ]
  • Anamnestic information, clinical parameters and complications related to HZ. [ Time Frame: Between Day 0 and Day 270 ]
  • Direct medical, direct non-medical and indirect costs related to HZ. [ Time Frame: Between Day 0 and Day 90 ]
  • Pain assessment in HZ subjects. [ Time Frame: At Day 90 ]
  • Quality of life assessment in HZ subjects [ Time Frame: Day 15, Day 30, Day 60 and Day 90 ]
  • Direct medical, direct non-medical and indirect costs related to PHN. [ Time Frame: At Day 90, Day 180 and Day 270 ]
  • Pain assessment in PHN subjects. [ Time Frame: At Day 90, Day 180 and Day 270 ]
  • Quality of life assessment in PHN subjects. [ Time Frame: At Day 90, Day 180 and Day 270 ]

Enrollment: 552
Study Start Date: March 2012
Study Completion Date: May 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
Subjects presenting with HZ episode.
Other: Data collection
HZ and PHN booklet questionnaire and zoster brief pain inventory (ZBPI) questionnaire.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult population, male or female, ≥50 years of age presenting with a HZ episode.
Criteria

Inclusion Criteria:

  • A male or female >=50 years of age at the time of study enrolment presenting with acute HZ;
  • HZ diagnosis for this HZ episode;

    • is the subject's first outpatient diagnosis; OR
    • took place at another site/ centre up to seven days before the initial visit for the present study;
  • Ability to comply with study procedures*;
  • Written informed consent obtained from the subject*. Note: * will be applicable to secondary objectives only and not for the primary objective to calculate incidence.

Exclusion Criteria:

• Subject participating in another research study. Note: This exclusion criteria is applicable to secondary objectives only and not for the primary objectives to calculate incidence.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521286


Locations
Spain
GSK Investigational Site
Barcelona, Spain, 08034
GSK Investigational Site
Madrid, Spain, 28037
GSK Investigational Site
Valencia, Spain, 46020
GSK Investigational Site
Valencia, Spain, 46021
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01521286     History of Changes
Other Study ID Numbers: 114617
First Submitted: January 26, 2012
First Posted: January 30, 2012
Last Update Posted: September 28, 2015
Last Verified: September 2015

Keywords provided by GlaxoSmithKline:
Spain
cost
complications
incidence
adults
quality of life
Herpes Zoster
Surveillance

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


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