Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy

McNeil-PPC

Status: Completed

Conditions: Smoking Cessation

Treatments: Drug: Nicotine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00882375

2008-006845-13 (EudraCT Number)

A6431111

Details and patient eligibility

About

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

Full description

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

Enrollment: 479 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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479 participants in 2 patient groups, including a placebo group

Nicotine

Experimental group

Description:

Nicotine

Treatment:

Drug: Nicotine

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo