Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy

• Status: Completed
• Trial end date: 2016-02-10
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of a novel nicotine product for continuous abstinence from smoking. Efficacy of product will be evaluated by assessments of self-reported abstinence, verified by exhaled carbon monoxide (CO) levels.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
• Collaborators: GlaxoSmithKline; McNeil AB
• Treatments: Nicotine

Criteria

Inclusion Criteria:

Subjects must be males or females 18-85 years of age who currently smoke cigarettes daily and are willing to stop smoking

Exclusion Criteria:

History of cardiovascular disease, stomach ulcer or diabetes unless physician's written approval is obtained.

Use of other forms of tobacco/nicotine containing products other than cigarettes within 30 days before baseline visit.

Use of nicotine replacement therapies or other smoking cessation medicines/non-drug therapies within 30 days before the baseline visit.

Pregnancy or intending to become pregnant.

Hypersensitivity to the product, history of alcohol or substance abuse.