Herpes ZosterNCT01521286
Study to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Spain
An observational study of Herpes Zoster, run by GlaxoSmithKline at 4 sites in Spain.
Trial 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) Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Data collection
- How many people
- 552 participants
- Where
- 4 sitesSpain
- Study dates
- Mar 2012to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult population, male or female, ≥50 years of age presenting with a HZ episode.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
GSK Investigational Site
Barcelona, 08034
GSK Investigational Site
Madrid, 28037
GSK Investigational Site
Valencia, 46020
GSK Investigational Site
Valencia, 46021
About this study
Official title: Population Based Surveillance to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Spain
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)
- Conditions
- Herpes Zoster
- Being tested
- Data collection
- Keywords
- Spain, cost, complications, incidence, adults, quality of life, Herpes Zoster, Surveillance
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
HZ and PHN booklet questionnaire and zoster brief pain inventory (ZBPI) questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Subjects presenting with HZ episode. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of HZ cases as recorded per participating practice, overall and within a specific age group and gender.
Measured: up to one year
Secondary outcomes (8)
Occurrence of PHN, i.e. persistence of HZ-related pain.
Measured: 90, 180, and 270 days after onset of HZ.
Anamnestic information, clinical parameters and complications related to HZ.
Measured: Between Day 0 and Day 270
Direct medical, direct non-medical and indirect costs related to HZ.
Measured: Between Day 0 and Day 90
Pain assessment in HZ subjects.
Measured: At Day 90
Quality of life assessment in HZ subjects
Measured: Day 15, Day 30, Day 60 and Day 90
Direct medical, direct non-medical and indirect costs related to PHN.
Measured: At Day 90, Day 180 and Day 270
Pain assessment in PHN subjects.
Measured: At Day 90, Day 180 and Day 270
Quality of life assessment in PHN subjects.
Measured: At Day 90, Day 180 and Day 270
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521286
- Sponsor's protocol ID
- 114617
- Status last verified
- Sep 2015
- First submitted
- 26 Jan 2012
- Last updated
- 28 Sep 2015
- Results posted
- No
Publications
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.
PubMed 34013498
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Based Surveillance to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Spain
- ClinicalTrials.gov ID
- NCT01521286
- Acronym / sponsor ID
- 114617
- Conditions
- Herpes Zoster
- Keywords
- Spain, cost, complications, incidence, adults, quality of life, Herpes Zoster, Surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Data collectionSubjects presenting with HZ episode. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population, male or female, ≥50 years of age presenting with a HZ episode.
Key inclusion criteria (6 listed)
- A male or female >=50 years of age at the time of study enrolment presenting with acute HZ;
- HZ diagnosis for this HZ episode;
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionHZ and PHN booklet questionnaire and zoster brief pain inventory (ZBPI) questionnaire. | Other | Group A |
Primary outcome
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
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
- Derived from this study: PubMed 34013498Diez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herpes Zoster, run by GlaxoSmithKline at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01521286, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.