SmokingNCT01970995
Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting
A study testing THS 2.2 Menthol (mTHS 2.2), Smoking Abstinence (SA) and Menthol Conventional Cigarette (mCC) in people with Smoking, run by Philip Morris Products S.A. at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 23 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- THS 2.2 Menthol (mTHS 2.2), Smoking Abstinence (SA) and Menthol Conventional Cigarette (mCC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Osaki Hospital Tokyo Heart Center, 5-4-12, Kitashinagawa, Shinagawa-ku
Tokyo
About this study
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
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
- Being tested
- THS 2.2 Menthol (mTHS 2.2), Smoking Abstinence (SA), Menthol Conventional Cigarette (mCC)
- Keywords
- Candidate modified risk tobacco product, Conventional cigarettes, Reduced exposure, HPHCs, Ambulatory
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THS 2.2 Menthol (mTHS 2.2)Other
THS 2.2 Menthol ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting
Smoking Abstinence (SA)Other
SA for 5 days in confinement prolonged by 85 days in an ambulatory setting
Menthol Conventional Cigarette (mCC)Other
Subject's own preferred brand of mCC ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting
| Study group | Role | What they receive |
|---|---|---|
| THS 2.2 Menthol (mTHS 2.2) | Experimental | Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting Receives: Other: THS 2.2 Menthol (mTHS 2.2) |
| Smoking abstinence (SA) | Active comparator | Abstinence from smoking for 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting Receives: Other: Smoking Abstinence (SA) |
| Menthol Conventional Cigarette (mCC) | Active comparator | 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 Receives: Other: Menthol Conventional Cigarette (mCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares (LS) means are provided as descriptive statistics.
Measured: 5 days
Concentration of S-phenylmercapturic Acid (S-PMA)
Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares (LS) means are provided as descriptive statistics.
Measured: 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.
Measured: 5 days
Concentration of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol) (Total NNAL)
Concentrations measured at Day 90 in urine, adjusted for creatinine.
Geometric Least Squares (LS) means are provided as descriptive statistics.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Morris Products S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Masahiro Endo, MD, Principal investigator, Osaki Hospital Tokyo Heart CenterChristelle Haziza, PhD, Study chair, Philip Morris Products S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970995
- Sponsor's protocol ID
- ZRHM-REXA-07-JP
- Other IDs
- ZRHM-REXA-07-JP
- Status last verified
- Mar 2020
- First submitted
- 18 Oct 2013
- Last updated
- 23 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01970995
- Acronym / sponsor ID
- ZRHM-REXA-07-JP
- Conditions
- Smoking
- Keywords
- Candidate modified risk tobacco product, Conventional cigarettes, Reduced exposure, HPHCs, Ambulatory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Philip Morris Products S.A.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 28 Oct 2013 (estimated)
- Results
- Posted 7 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| THS 2.2 Menthol (mTHS 2.2) | Experimental | Other: 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 |
| Smoking abstinence (SA) | Active comparator | Other: Smoking Abstinence (SA)Abstinence from smoking for 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting |
| Menthol Conventional Cigarette (mCC) | Active comparator | Other: 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 |
Who may qualify
- Ages
- 23 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | THS 2.2 Menthol (mTHS 2.2) |
| Smoking Abstinence (SA)SA for 5 days in confinement prolonged by 85 days in an ambulatory setting | Other | Smoking abstinence (SA) |
| 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 | Other | Menthol Conventional Cigarette (mCC) |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masahiro Endo, MD principal investigator
Osaki Hospital Tokyo Heart Center
Christelle Haziza, PhD study chair
Philip Morris Products S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THS 2.2 Menthol (mTHS 2.2), Smoking Abstinence (SA) and Menthol Conventional Cigarette (mCC) in people with Smoking, run by Philip Morris Products S.A. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) (time frame: 5 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.