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NCT02396381 · ClinicalTrials.gov registry record · NA

Evaluation of Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 for 26 Weeks

A NA study, sponsored by Philip Morris Products S.A..

Completed
Registry status
NA
Development phase
1,039
Enrollment target

NCT02396381: Completed NA study, sponsored by Philip Morris Products S.A..

NCT02396381 is a NA study that has completed, run by Philip Morris Products S.A.. The registered enrollment target is 1,039 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02396381, a NA study, has completed, sponsored by Philip Morris Products S.A..

COMPLETED
Registry status
NA
Development phase
1,039 participants
Enrollment target

Study Summary

The aim of the study is to demonstrate clinical, biological and functional health changes in smokers switching to the candidate modified risk tobacco product: Tobacco Heating System 2.2 (THS 2.2) as compared to smokers continuing smoking their conventional cigarettes (CC) over a 26-week period. To characterize the study as successful, at least 5 clinical risk endpoints should move in the direction of smoking cessation and these results would be statistically significant. The main analysis will be defined a priori (using the Hailperin-Ruger approach) and will be made between THS 2.2 use and CC use as "per actual product used" and product use categories.

Primary Outcome

Concentrations measured in serum. Geometric Least Squares means are provided as descriptive statistics.

Interventions

  • OTHER CC
  • OTHER THS 2.2

Trial Details

FieldValue
Enrollment Target 1,039 participants
Start Date 2015-03-12
Est. Completion 2017-08-01
Phase NA
Philip Morris Products S.A.

11 total trials

What the finished NCT02396381 record still lists

NCT02396381 is an interventional study that assigns participants to a tested intervention. Its 1,039 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (26% lower).

The record links to 0 conditions, and to 2 interventions - of which CC is the first listed.

NCT02396381 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02396381 about?

NCT02396381 is a clinical study titled "Evaluation of Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 for 26 Weeks". The aim of the study is to demonstrate clinical, biological and functional health changes in smokers switching to the candidate modified risk tobacco product: Tobacco Heating System 2.2 (THS 2.2) as compared to smokers continuing smoking their conventional cigarettes (CC) over a 26-week period. To ...

What is the current status of trial NCT02396381?

This trial is currently completed. It is a NA study. The enrollment target is 1,039 participants. The study started on 2015-03-12. Estimated completion is 2017-08-01.

What interventions are being tested in trial NCT02396381?

The interventions under investigation include: CC (OTHER), THS 2.2 (OTHER).

Who is sponsoring clinical trial NCT02396381?

This trial is sponsored by Philip Morris Products S.A., which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02396381's enrollment target sits among peer trials

1,039 101st of 2000 higher than 1,900 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02396381, the US trial registry maintained by the National Library of Medicine. NCT02396381 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.