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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