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NCT02355665 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by McNeil Consumer Healthcare Division of McNEIL-PPC.

Completed
Registry status
Phase 3
Development phase
1,198
Enrollment target

NCT02355665: Completed Phase 3 study, sponsored by McNeil Consumer Healthcare Division of McNEIL-PPC.

NCT02355665 is a Phase 3 study that has completed, run by McNeil Consumer Healthcare Division of McNEIL-PPC. The registered enrollment target is 1,198 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT02355665, a Phase 3 study, has completed, sponsored by McNeil Consumer Healthcare Division of McNEIL-PPC.

COMPLETED
Registry status
Phase 3
Development phase
1,198 participants
Enrollment target

Study 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.

Primary Outcome

Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking

Interventions

  • DRUG Placebo
  • DRUG Nicotine Spray

Trial Details

FieldValue
Enrollment Target 1,198 participants
Start Date 2015-01-31
Est. Completion 2016-02-10
Phase Phase 3

What the finished NCT02355665 record still lists

NCT02355665 is an interventional study that assigns participants to a tested intervention. Its 1,198 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02355665 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02355665 about?

NCT02355665 is a clinical study titled "Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy". 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.

What is the current status of trial NCT02355665?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,198 participants. The study started on 2015-01-31. Estimated completion is 2016-02-10.

What interventions are being tested in trial NCT02355665?

The interventions under investigation include: Placebo (DRUG), Nicotine Spray (DRUG).

Who is sponsoring clinical trial NCT02355665?

This trial is sponsored by McNeil Consumer Healthcare Division of McNEIL-PPC, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02355665's enrollment target sits among peer trials

1,198 228th of 2000 higher than 1,773 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02355665, the US trial registry maintained by the National Library of Medicine. NCT02355665 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.