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

NCT02355665 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1198

Last updated 2019-01-08

Study results available
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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

  • Tobacco Dependence

Interventions

DRUG

Nicotine Spray

Nicotine Spray

DRUG

Placebo

Placebo to match nicotine spray

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • McNeil AB

    collaborator INDUSTRY

  • McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrew Myers, MD · McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02355665 on ClinicalTrials.gov