Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy

Smoking Cessation Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882375
• Other study ID #: A6431111
• Secondary ID: 2008-006845-13
• Status: Completed
• Phase: N/A
• First received: April 15, 2009
• Last updated: June 28, 2012
• Start date: March 2009
• Est. completion date: June 2010

Study information

• Verified date: June 2012
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

A comparison of a novel nicotine replacement therapy and placebo treatment in smokers motivated to quit smoking.

Description:

Efficacy and safety study following use of a novel nicotine replacement therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 479
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Nicotine
Nicotine administered using novel NRT user instructions
• Placebo
Placebo administered using novel NRT user instructions

Locations

Country	Name	City	State
Denmark	Gentofte University Hospital	Hellerup
Germany	University of Heidelberg	Mannheim
Germany	University Hospital of Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
McNeil AB

Countries where clinical trial is conducted

Denmark,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported continuous abstinence from smoking verified by exhaled CO levels of less than 10 ppm.		at weeks 2, 6, 24 and 52	No
Secondary	Self-reported continuous abstinence from smoking, verified by exhaled CO levels of less than 10 ppm.		weeks 2, 4, 8, 12, 16, and 20	No
Secondary	Self-reported 7-day point prevalence abstinence from smoking verified by exhaled CO levels of less than 10 ppm.		weeks 4, 6, 8, 12, 16, 20, 24, and 52	No
Secondary	Ratings of craving/urge to smoke and withdrawal symptoms.		baseline to 24 weeks	No
Secondary	Cotinine levels in saliva.		baseline, and weeks 2, 6, 12 and 24	No
Secondary	Product acceptability		weeks 1, 6 and 12	No