Study to Estimate the Burden of Herpes Zoster (HZ) and Post-herpetic Neuralgia (PHN) in Italy
|ClinicalTrials.gov Identifier: NCT01772160|
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : August 18, 2017
|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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772160
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|