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Reduced Exposure Study in Smokers Using the Tobacco Heating System 2.2 (THS 2.2) for 5 Days in a Confinement Setting

NCT01970982 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2020-03-12

Study results available
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Summary

The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating System 2.2 (THS 2.2) for 5 consecutive days by adult Japanese healthy smokers affects the levels of biomarkers of exposure for selected harmful and potentially harmful constituents (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).

Conditions

  • Smoking

Interventions

OTHER

Tobacco Heating System (THS 2.2)

THS 2.2 ad libitum for 5 days in confinement

OTHER

Smoking abstinence (SA)

SA for 5 days in confinement

OTHER

Conventional cigarette (CC)

Subject's own preferred brand of CC ad libitum for 5 days in confinement

Sponsors & Collaborators

  • Philip Morris Products S.A.

    lead INDUSTRY

Principal Investigators

  • Takuya Kunito, MD · Higashi Shinjuku Clinic

  • Christelle Haziza, PhD · Philip Morris Products S.A.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
23 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-12-31
Completion
2014-07-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01970982 on ClinicalTrials.gov