Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01970995 |
Recruitment Status :
Completed
First Posted : October 28, 2013
Results First Posted : February 7, 2017
Last Update Posted : March 23, 2020
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking | Other: THS 2.2 Menthol (mTHS 2.2) Other: Smoking Abstinence (SA) Other: Menthol Conventional Cigarette (mCC) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | A Randomized, Controlled, Multi-center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Smokers Switching to THS 2.2 Menthol or Smoking Abstinence Compared to Smoking Menthol Conventional Cigarettes, for 90 Days |
Study Start Date : | August 2013 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | November 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: THS 2.2 Menthol (mTHS 2.2)
Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting
|
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 |
Active Comparator: Smoking abstinence (SA)
Abstinence from smoking for 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting
|
Other: Smoking Abstinence (SA)
SA for 5 days in confinement prolonged by 85 days in an ambulatory setting |
Active Comparator: Menthol Conventional Cigarette (mCC)
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
|
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 |
- Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) [ Time Frame: 5 days ]
Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares (LS) means are provided as descriptive statistics.
- Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) [ Time Frame: 5 days ]
Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares (LS) means are provided as descriptive statistics.
- Concentration of S-phenylmercapturic Acid (S-PMA) [ Time Frame: 5 days ]
Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares (LS) means are provided as descriptive statistics.
- Levels of Carboxyhemoglobin (COHb) [ Time Frame: 5 days ]
% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.
Geometric Least Squares means are provided as descriptive statistics.
- Concentration of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol) (Total NNAL) [ Time Frame: 90 days ]
Concentrations measured at Day 90 in urine, adjusted for creatinine.
Geometric Least Squares (LS) means are provided as descriptive statistics.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 23 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Subject is Japanese.
- Smoking, healthy subject as judged by the Investigator.
- Subject smokes at least 10 commercially available mCCs per day (no brand restrictions) for the last 4 weeks, based on self-reporting.
- Subject has smoked for at least the last 3 consecutive years.
- Subject does not plan to quit smoking in the next 3 months.
Exclusion Criteria:
- As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
- The subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer) which has an impact on cytochrome P450 1 A2 (CYP1A2) or cytochrome P450 2 A6 (CYP2A6) activity.
- For women: Subject is pregnant or is breast feeding.
- For women: Subject does not agree to use an acceptable method of effective contraception.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970995
Japan | |
Osaki Hospital Tokyo Heart Center, 5-4-12, Kitashinagawa, Shinagawa-ku | |
Tokyo, Japan |
Principal Investigator: | Masahiro Endo, MD | Osaki Hospital Tokyo Heart Center | |
Study Chair: | Christelle Haziza, PhD | Philip Morris Products S.A. |
Documents provided by Philip Morris Products S.A.:
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 Posted: | October 28, 2013 Key Record Dates |
Results First Posted: | February 7, 2017 |
Last Update Posted: | March 23, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Candidate modified risk tobacco product Conventional cigarettes Reduced exposure HPHCs Ambulatory |
Menthol Antipruritics Dermatologic Agents |