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Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy

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ClinicalTrials.gov Identifier: NCT00882375
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : July 2, 2012
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )

April 15, 2009
April 16, 2009
July 2, 2012
March 2009
June 2010   (Final data collection date for primary outcome measure)
Self-reported continuous abstinence from smoking verified by exhaled CO levels of less than 10 ppm. [ Time Frame: at weeks 2, 6, 24 and 52 ]
Same as current
Complete list of historical versions of study NCT00882375 on ClinicalTrials.gov Archive Site
  • Self-reported continuous abstinence from smoking, verified by exhaled CO levels of less than 10 ppm. [ Time Frame: weeks 2, 4, 8, 12, 16, and 20 ]
  • Self-reported 7-day point prevalence abstinence from smoking verified by exhaled CO levels of less than 10 ppm. [ Time Frame: weeks 4, 6, 8, 12, 16, 20, 24, and 52 ]
  • Ratings of craving/urge to smoke and withdrawal symptoms. [ Time Frame: baseline to 24 weeks ]
  • Cotinine levels in saliva. [ Time Frame: baseline, and weeks 2, 6, 12 and 24 ]
  • Product acceptability [ Time Frame: weeks 1, 6 and 12 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy
Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy. A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, 52 Week Study in Smokers Motivated to Quit.
A comparison of a novel nicotine replacement therapy and placebo treatment in smokers motivated to quit smoking.
Efficacy and safety study following use of a novel nicotine replacement therapy.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Smoking Cessation
  • Drug: Nicotine
    Nicotine administered using novel NRT user instructions
    Other Name: NRT
  • Drug: Placebo
    Placebo administered using novel NRT user instructions
  • Experimental: Nicotine
    Nicotine
    Intervention: Drug: Nicotine
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Roche F, Pépin JL, Achour-Crawford E, Tamisier R, Pichot V, Celle S, Maudoux D, Chouchou F, Ntougou-Assoumou HG, Lévy P, Barthélémy JC; PROOF Study Group. At 68 years, unrecognised sleep apnoea is associated with elevated ambulatory blood pressure. Eur Respir J. 2012 Sep;40(3):649-56. Epub 2012 Apr 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
479
465
June 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years or older male and female cigarette smokers motivated and willing to stop smoking
  • Female participants of child-bearing potential should use a medically acceptable means of birth control.
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate.

Exclusion Criteria:

  • Unstable angina pectoris or myocardial infarction during the previous 3 months.
  • Pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential).
  • Participation in other clinical trials within the previous three months and during study participation.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Germany
 
 
NCT00882375
A6431111
2008-006845-13 ( EudraCT Number )
No
Not Provided
Not Provided
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
McNeil AB
Not Provided
Study Director: Elisabeth Kruse, PhD McNeil AB
Johnson & Johnson Consumer and Personal Products Worldwide
June 2012

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