Investigate the Exposure to Selected Smoke Constituents in Smokers Switching to Distillation Based Smoking Article
![]() |
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: NCT00812279 |
Recruitment Status
:
Completed
First Posted
: December 22, 2008
Last Update Posted
: March 6, 2009
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | December 19, 2008 | |||
First Posted Date ICMJE | December 22, 2008 | |||
Last Update Posted Date | March 6, 2009 | |||
Study Start Date ICMJE | November 2008 | |||
Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
To demonstrate a reduction in the three primary biomarkers of exposure: Carboxyhaemoglobin concentration in blood, Urinary excretion of S-phenylmercapturic acid and urinary excretion of NNAL and NNAL-glucuronides (total NNAL) [ Time Frame: 5 days ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00812279 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Investigate the Exposure to Selected Smoke Constituents in Smokers Switching to Distillation Based Smoking Article | |||
Official Title ICMJE | A Controlled, Randomised, Open-Label, 3-Arm Parallel Single-Centre Confinement Study to Investigate Exposure to Selected Smoke Constituents in Smokers Switching From Conventional Cigarettes to SMAR Cigarettes for 5 Days | |||
Brief Summary | The overall purpose of this clinical study conducted in confinement under well-defined conditions is to obtain initial data on the levels of human body exposure to selected smoked constituents of the SMAR cigarette. The main objective of this study is to compare the biomarkers of exposure to cigarette smoke constituents in smokers switching to SMAR and to biomarkers in smokers of conventional cigarettes (CC). The biomarkers of exposure will be measured in blood and urine samples collected from the subjects. Moreover, the biomarkers in subjects smoking conventional or SMAR cigarettes will be compared with those biomarkers in smokers who stop smoking for 5 days. The short term safety of this new product will also be evaluated. |
|||
Detailed Description | This is a controlled, randomised, open-label, 3-arm parallel single centre confinement study to investigate exposure to selected smoke constituents in smokers switching from CC to SMAR for 5 days. 112 eligible subjects will be randomised to the 3 study arms: SMAR, conventional cigarettes (CC) and smoking cessation (SC) in a 2:1:1 ratio. Following the screening visit (within 4 weeks prior to the day of admission), the study will be run over an 8-day period in a confined environment, consisting of the admission day (D-2), a 2-day baseline period (D-1 and D0), and a 5-day exposure period (D1 to D5). Subjects will be discharged in the morning of D6. From the discharge of the subject, a 7-day safety follow-up period will be carried out (until D13). |
|||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
|||
Condition ICMJE | Smoking | |||
Intervention ICMJE |
|
|||
Study Arms |
|
|||
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 |
112 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | February 2009 | |||
Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 23 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Poland | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00812279 | |||
Other Study ID Numbers ICMJE | YVD-CS01-EU | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | John L. Magnette - Head Clinical Assessment, Philip Morris Products SA | |||
Study Sponsor ICMJE | Philip Morris Products S.A. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | Philip Morris Products S.A. | |||
Verification Date | March 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |