Study to Estimate the Burden of Herpes Zoster (HZ) and Post-herpetic Neuralgia (PHN) in Italy
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|ClinicalTrials.gov Identifier: NCT01772160|
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : July 2, 2018
|Condition or disease||Intervention/treatment|
|Herpes Zoster||Other: Data collection|
The surveillance/recruitment period will take approximately 2 years and once the enrolment of HZ patients has ended, the study will continue for a maximum of 9 months to allow for completion of the follow-up of potential PHN cases.
The data will be captured at protocol specified time-points based on the time of enrolment of each subject.
|Study Type :||Observational|
|Actual Enrollment :||395 participants|
|Official Title:||Population Based Surveillance to Estimate the Burden of Herpes Zoster and Post-herpetic Neuralgia in Italy|
|Actual Study Start Date :||February 26, 2013|
|Actual Primary Completion Date :||October 5, 2016|
|Actual Study Completion Date :||October 5, 2016|
Subjects presenting with an HZ episode.
Other: Data collection
HZ/PHN booklet, HZ/PHN file and logbook. HZ/PHN booklet will be completed by the patient and the HZ/PHN file and logbook will be completed by the participating general practitioner.
- Occurrence of HZ cases as recorded per participating centre, overall and within a specific age group and gender. [ Time Frame: Day 0 to 2 years approximately. ]
- Occurrence of PHN, i.e. persistence of HZ-related pain. [ Time Frame: Days 90, 180, and 270 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 270. ]
- Pain assessment in HZ patients. [ Time Frame: At Day 90. ]
- Quality of life assessment in HZ patients. [ Time Frame: At 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 patients. [ Time Frame: At Day 90, Day 180 and Day 270. ]
- Quality of life assessment in PHN patients. [ Time Frame: At Day 90, Day 180 and Day 270. ]
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): NCT01772160
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|