Trials / Completed
CompletedNCT02355665
Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study Using a Naturalistic Clinical Model to Measure the Efficacy and Safety of a Novel Nicotine Replacement Therapy in Smokers Motivated to Quit
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,198 (actual)
- Sponsor
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nicotine Spray | Nicotine Spray |
| DRUG | Placebo | Placebo to match nicotine spray |
Timeline
- Start date
- 2015-01-31
- Primary completion
- 2015-09-30
- Completion
- 2016-02-10
- First posted
- 2015-02-04
- Last updated
- 2019-01-08
- Results posted
- 2019-01-08
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02355665. Inclusion in this directory is not an endorsement.