MedTrace Logo

Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting

NCT01970995 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2020-03-23

Study results available
· View outcomes & findings →

Summary

The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS 2.2) for 5 days in confinement and after 85 days of product use in an ambulatory setting, by Japanese adult healthy smokers results in a reduction in the levels of biomarkers of exposure for selected harmful and potentially harmful smoke constituents (HPHCs) compared to smokers continuing smoking their own preferred brand of menthol conventional cigarette (mCC) and smoking abstinence (SA). Smokers who remained abstinent from SA were used as a benchmark to provide context to the exposure reduction.

Conditions

  • Smoking

Interventions

OTHER

THS 2.2 Menthol (mTHS 2.2)

THS 2.2 Menthol ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting

OTHER

Smoking Abstinence (SA)

SA for 5 days in confinement prolonged by 85 days in an ambulatory setting

OTHER

Menthol Conventional Cigarette (mCC)

Subject's own preferred brand of mCC ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting

Sponsors & Collaborators

  • Philip Morris Products S.A.

    lead INDUSTRY

Principal Investigators

  • Masahiro Endo, MD · Osaki Hospital Tokyo Heart Center

  • 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
2013-08-31
Primary Completion
2014-07-31
Completion
2014-11-30

Countries

  • Japan

Study Locations

More Related Trials

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 NCT01970995 on ClinicalTrials.gov