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| ID | Type | Description | Link |
|---|---|---|---|
| ZRHR-REXC-04-JP | Other Identifier | Philip Morris Products S.A. |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tobacco Heating System (THS 2.2) | Experimental | Ad libitum use of THS 2.2 for 5 days in confinement |
|
| Smoking abstinence (SA) | Sham Comparator | Abstinence from smoking for 5 days in confinement |
|
| Conventional cigarette (CC) | Active Comparator | Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobacco Heating System (THS 2.2) | Other | THS 2.2 ad libitum for 5 days in confinement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) | Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares LS) means are provided as descriptive statistics. | 5 days |
| Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) | Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics. | 5 days |
| Concentration of S-phenylmercapturic Acid (S-PMA) | Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics. | 5 days |
| Levels of Carboxyhemoglobin (COHb) | % 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. | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takuya Kunito, MD | Higashi Shinjuku Clinic | Principal Investigator |
| Christelle Haziza, PhD | Philip Morris Products S.A. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Higashi Shinjuku Clinic, Daito Building, 1-11-3, Okubo, Shinjuku-ku | Tokyo | Japan |
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Enrolled and randomized population = 160 subjects
Number of subjects enrolled but NOT randomized (who tried the THS 2.2 at Day -2) = 6
Study initiated (first subject screened): 23 July 2013
At admission (Day -2), all the subjects performed a product trial of the THS 2.2. During the baseline period, they continued smoking their single preferred brand of CC. Then, on Day 0, subjects were randomized to one of the 3 study arms (THS 2.2, CC or SA) in a 2:1:1 ratio.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tobacco Heating System (THS 2.2) | Ad libitum use of THS 2.2 for 5 days in confinement |
| FG001 | Conventional Cigarette (CC) | Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement |
| FG002 | Smoking Abstinence (SA) | Abstinence from smoking for 5 days in confinement |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The study population consisted of all the randomized subjects who had at least 1 post randomization product use experience (THS 2.2 or CC arms), and 1 valid biomarker of exposure (BoExp) measurement.
160 randomized subjects: 80 in THS 2.2, 40 in CC and 40 in SA
158 completers: 2 subjects (SA arm) voluntarily withdrew on Day 1 and Day 3
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| ID | Title | Description |
|---|---|---|
| BG000 | Tobacco Heating System (THS 2.2) | Ad libitum use of THS 2.2 for 5 days in confinement |
| BG001 | Conventional Cigarette (CC) | Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) | Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares LS) means are provided as descriptive statistics. | The analysis was performed on the full analysis set (FAS) population. The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid biomarker of exposure (BoExp) measurement (THS 2.2, CC, SA arms). | Posted | Least Squares Mean | 95% Confidence Interval | pg/mg creat | 5 days |
|
From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 166 subjects: 160 randomized subjects (80 in THS 2.2, 40 in CC and 40 in SA) and 6 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tobacco Heating System (THS 2.2) | Ad libitum use of THS 2.2 for 5 days in confinement |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood triglycerides increased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christelle HAZIZA, PhD | Philip Morris Products S.A. | +41 (58) 242 2625 | Christelle.Haziza@pmi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 8, 2013 | Mar 2, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 16, 2014 | Mar 2, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Smoking abstinence (SA) | Other | SA for 5 days in confinement |
|
| Conventional cigarette (CC) | Other | Subject's own preferred brand of CC ad libitum for 5 days in confinement |
|
| BG002 | Smoking Abstinence (SA) | Abstinence from smoking for 5 days in confinement |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Daily CC consumption at Screening | Number | participants |
|
Ad libitum use of subject's own preferred brand of CC for 5 days in confinement |
| OG002 | Smoking Abstinence (SA) | Abstinence from smoking for 5 days in confinement |
|
|
|
| Primary | Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) | Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics. | The analysis was performed on the full analysis set (FAS) population. The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms). | Posted | Least Squares Mean | 95% Confidence Interval | ng/mg creat | 5 days |
|
|
|
|
| Primary | Concentration of S-phenylmercapturic Acid (S-PMA) | Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics. | The analysis was performed on the full analysis set (FAS) population. The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms). | Posted | Least Squares Mean | 95% Confidence Interval | pg/mg creat | 5 days |
|
|
|
|
| Primary | Levels of Carboxyhemoglobin (COHb) | % 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. | The analysis was performed on the full analysis set (FAS) population. The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms). | Posted | Least Squares Mean | 95% Confidence Interval | % of saturation of hemoglobin | 5 days |
|
|
|
|
| 0 |
| 80 |
| 2 |
| 80 |
| EG001 | Conventional Cigarette (CC) | Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement | 0 | 40 | 2 | 40 |
| EG002 | Smoking Abstinence (SA) | Abstinence from smoking for 5 days in confinement | 0 | 40 | 0 | 40 |
| EG003 | Enrolled But Not Randomized | Subjects who tried the THS 2.2 at Admission (Day -2) but were not randomized in 1 of the 3 arms as they were back-up subjects | 0 | 6 | 0 | 6 |
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.
LS mean ratio THS 2.2:CC |
| Superiority or Other (legacy) |
LS mean ratio THS 2.2:CC |
| Superiority or Other (legacy) |
LS mean ratio THS 2.2:CC |
| Superiority or Other (legacy) |