Study to Estimate the Burden of Herpes Zoster and Posther... | NCT01521286

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

NCT01521286

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Sep 28, 2015Estimated

Enrollment

552Actual

Phase

Not provided

Conditions

Herpes Zoster

Interventions

Data collection

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Nov 2014Actual

Completion Date

May 2015Actual

First Submitted Date

Jan 26, 2012

First Submission Date that Met QC Criteria

Jan 27, 2012

First Posted Date

Jan 30, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2015

Last Update Posted Date

Sep 28, 2015Estimated

Description Module

Brief Summary

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)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

552Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		Subjects presenting with HZ episode.	Other: Data collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data collection	Other	HZ and PHN booklet questionnaire and zoster brief pain inventory (ZBPI) questionnaire.	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total number of HZ cases as recorded per participating practice, overall and within a specific age group and gender.		up to one year

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of PHN, i.e. persistence of HZ-related pain.		90, 180, and 270 days after onset of HZ.
Anamnestic information, clinical parameters and complications related to HZ.		Between Day 0 and Day 270

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult population, male or female, ≥50 years of age presenting with a HZ episode.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Barcelona		08034	Spain
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34013498	Derived	Diez-Domingo J, Curran D, Cambronero MDR, Garcia-Martinez JA, Matthews S. Economic Burden and Impact on Quality of Life of Herpes Zoster in Spanish Adults Aged 50 Years or Older: A Prospective Cohort Study. Adv Ther. 2021 Jun;38(6):3325-3341. doi: 10.1007/s12325-021-01717-7. Epub 2021 May 19.

ID	Term
D000073618	Varicella Zoster Virus Infection
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care