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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
Recruitment Status : Completed
First Posted : October 28, 2013
Results First Posted : February 7, 2017
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Tracking Information
First Submitted Date  ICMJE October 18, 2013
First Posted Date  ICMJE October 28, 2013
Results First Submitted Date  ICMJE December 14, 2016
Results First Posted Date  ICMJE February 7, 2017
Last Update Posted Date March 23, 2020
Study Start Date  ICMJE August 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2013)
  • To demonstrate the levels of monohydroxybutenyl mercapturic acid (MHBMA); 3-hydroxypropylmercapturic acid (3-HPMA); S-phenylmercapturic acid (S-PMA) expressed as concentration adjusted to creatinine in 24-hour urine and carboxyhemoglobin (COHb) in blood. [ Time Frame: 5 days ]
    To demonstrate the reduction of exposure to respectively 1,3-butadiene; acrolein; benzene and carbon monoxide (HPHCs) after 5 days of switching from mCC to THS 2.2 Menthol as compared to mCC.
  • To demonstrate the levels of Total 4-(methylnitrosamino)-1-(3- pyridyl)-1-butanol) (Total NNAL) [ Time Frame: 90 days ]
    To demonstrate the reduction of exposure to 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone after 90 days of switching from mCC to THS 2.2 Menthol as compared to mCC.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting
Official Title  ICMJE 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
Brief 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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Smoking
Intervention  ICMJE
  • 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
  • Other: Smoking Abstinence (SA)
    SA for 5 days in confinement prolonged by 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
Study Arms  ICMJE
  • 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
    Intervention: Other: THS 2.2 Menthol (mTHS 2.2)
  • Active Comparator: Smoking abstinence (SA)
    Abstinence from smoking for 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting
    Intervention: Other: Smoking Abstinence (SA)
  • 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
    Intervention: Other: Menthol Conventional Cigarette (mCC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2014)
160
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2013)
350
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 23 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01970995
Other Study ID Numbers  ICMJE ZRHM-REXA-07-JP
ZRHM-REXA-07-JP ( Other Identifier: Philip Morris Products S.A. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Philip Morris Products S.A.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Philip Morris Products S.A.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Masahiro Endo, MD Osaki Hospital Tokyo Heart Center
Study Chair: Christelle Haziza, PhD Philip Morris Products S.A.
PRS Account Philip Morris Products S.A.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP