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

Phase 3 Completed 1198 enrolled McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. GlaxoSmithKline · collab McNeil AB · collab

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2015-01-31
Primary completion: 2015-09-30
Completion: 2016-02-10

Outcome

Met primary endpoint

paper statistically significantly greater in the NMS group compared with the placebo group (5.0% vs 2.5%, p = .021). PMID 30452732 ↗

registry analysis (superiority test); Placebo vs Nicotine; p = 0.021; Estimated Success Rate Ratio 2.00 (95% CI 1.10 to 3.66) NCT02355665 ↗

Publications

Nides M, Danielsson T, Saunders F, Perfekt R, Kapikian R, Solla J, Leischow SJ, Myers A. Efficacy and Safety of a Nicotine Mouth Spray for Smoking Cessation: A Randomized, Multicenter, Controlled Study in a Naturalistic Setting. Nicotine Tob Res. 2020 Mar 16;22(3):339-345. doi: 10.1093/ntr/nty246.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nicotine	Unknown	—	Other