At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,198 enrolled
Drug / intervention
Nicotine Spray +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.·interventional·Posted Feb 4, 2015·Updated Jan 8, 2019
In Brief
A Phase 3 clinical trial evaluating Nicotine Spray and Placebo for Tobacco Dependence. Completed, enrolled 1,198 participants across 8 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Dependence
CountriesUnited States
CollaboratorsGlaxoSmithKline, McNeil AB
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJan 2015
First PostedFeb 2015
Primary CompletionSep 2015
Study CompletionFeb 2016
TodayJul 2026
First PostedFeb 4, 2015
Enrollment StartJan 31, 2015
Primary CompletionSep 30, 2015
Study CompletionFeb 10, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.4 years ago
Interventions
Nicotine Spraydrug
Nicotine Spray
Placebodrug
Placebo to match nicotine spray