Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting
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| ClinicalTrials.gov Identifier: NCT01970995 |
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Recruitment Status :
Completed
First Posted : October 28, 2013
Results First Posted : February 7, 2017
Last Update Posted : March 23, 2020
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Sponsor:
Philip Morris Products S.A.
Information provided by (Responsible Party):
Philip Morris Products S.A.
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other |
| Condition |
Smoking |
| Interventions |
Other: THS 2.2 Menthol (mTHS 2.2) Other: Smoking Abstinence (SA) Other: Menthol Conventional Cigarette (mCC) |
| Enrollment | 160 |
Participant Flow
| Recruitment Details |
Study initiated (first subject screened): 01 August 2013 At admission (Day -2), all the subjects performed a product trial of the THS 2.2 Menthol. During the baseline period, they continued smoking their single preferred brand of mCC. Then, on Day 0, they were randomized to one of the 3 study arms (mTHS 2.2, mCC or SA) in a 2:1:1 ratio. |
| Pre-assignment Details |
Enrolled and randomized population = 160 subjects
Number of subjects enrolled but NOT randomized (who tried the mTHS 2.2 at Day -2) = 0 |
| Arm/Group Title | THS 2.2 Menthol (mTHS 2.2) | Menthol Conventional Cigarette (mCC) | Smoking Abstinence (SA) |
|---|---|---|---|
 Arm/Group Description |
Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting | Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting | Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting |
| Period Title: Confinement Period (Population at Day 5) | |||
| Started | 78 | 42 | 40 |
| Completed | 77 | 41 | 39 |
| Not Completed | 1 | 1 | 1 |
| Reason Not Completed | |||
| Withdrawal by Subject | 1 | 1 | 1 |
| Period Title: End of Study (Population at Day 90) | |||
| Started | 77 | 41 | 39 |
| Completed | 76 | 41 | 38 |
| Not Completed | 1 | 0 | 1 |
| Reason Not Completed | |||
| Withdrawal by Subject | 1 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | THS 2.2 Menthol (mTHS 2.2) | Menthol Conventional Cigarette (mCC) | Smoking Abstinence (SA) | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting | Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting | Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting | Total of all reporting groups | |
| Overall Number of Baseline Participants | 78 | 42 | 40 | 160 | |
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Baseline Analysis Population Description |
Study population = all randomized subjects who had at least one post randomization product use experience and at least one valid biomarker of exposure measurement.
160 randomized subjects: 78 in mTHS 2.2, 42 in mCC and 40 in SA arms
155 completed, subjects who withdrew: 2 in mTHS 2.2, 1 in mCC and 2 in SA arms
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 78 participants | 42 participants | 40 participants | 160 participants | |
| 37.1 (10.58) | 37.4 (11.23) | 37.0 (9.96) | 37.2 (10.54) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 78 participants | 42 participants | 40 participants | 160 participants | |
| Female |
33 42.3%
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17 40.5%
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18 45.0%
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68 42.5%
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| Male |
45 57.7%
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25 59.5%
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22 55.0%
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92 57.5%
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Daily mCC consumption at Screening
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 78 participants | 42 participants | 40 participants | 160 participants |
| 10 to 19 cig/day | 40 | 23 | 21 | 84 | |
| > 19 cig/day | 38 | 19 | 19 | 76 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
We confirm we have the contractual provisions in place which specifies that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements.
The Intellectual Property rights and research results from the present study belongs to the Sponsor.
Results Point of Contact
| Name/Title: | Christelle HAZIZA, PhD |
| Organization: | Philip Morris Products S.A. |
| Phone: | +41 (58) 242 2625 |
| EMail: | Christelle.Haziza@pmi.com |
| Responsible Party: | Philip Morris Products S.A. |
| ClinicalTrials.gov Identifier: | NCT01970995 |
| Other Study ID Numbers: |
ZRHM-REXA-07-JP ZRHM-REXA-07-JP ( Other Identifier: Philip Morris Products S.A. ) |
| First Submitted: | October 18, 2013 |
| First Posted: | October 28, 2013 |
| Results First Submitted: | December 14, 2016 |
| Results First Posted: | February 7, 2017 |
| Last Update Posted: | March 23, 2020 |