Clinical Studies

Japanese Post-Market Cohort Study

First posted
Jan 13, 2017
Identifier
NCT03020667
Publication Site URL
Topic
Official Title

An Observational Cohort Study in Japan to Assess the Patterns of Product Use and Changes in Health Outcomes Associated With the Use of HeatSticks With the IQOS Tobacco Heating System

Brief Summary

The objectives and endpoints of this study will be analyzed in the study population of adults legally authorized to buy tobacco products. The study will describe the patterns of use of tobacco and nicotine containing products and self-reported health outcomes and health related events in CC (Cigarette) smokers and IQOS users in Japan. Note: The initial study record (posted to ClinicalTrials.gov) included a clinical sub-study designed to estimate population level differences in the biomarkers of exposure and clinical risk endpoints between IQOS users, CC smokers and never-smokers. However, due to low recruitment and retention of subjects, the clinical sub-study was terminated in May 2017 and the main study was terminated in March 2018. The study protocol was updated to remove the clinical sub-study objectives. This version of the study reflects the latest version of the updated study protocol.

Summary

Recruitment: Completed

Study Results: Available

Enrollment: 1124

Study Type: Observational

Other IDs: P1-PMC-01-JP

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