Trial · NCT02355665
Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy
NCT02355665, Phase 3, Completed, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.; results first posted 2019-01-08
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy. Trials, record NCT02355665. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02355665
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy
- NCT number
- NCT02355665
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,198 participants, actual
- Lead sponsor
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
- Conditions
- Tobacco Dependence
- Interventions
- Nicotine Spray, Placebo
- First posted
- 2015-02-04
- Last updated
- 2019-01-08
- Results first posted
- 2019-01-08
Source ClinicalTrials.gov
Registered outcomes214
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6 | Week 2 to Week 6 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking |
| Secondary | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12 | Week 2 to Week 12 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking |
| Secondary | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 26 | Week 2 to Week 26 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking |
| Secondary | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 4 | Week 2 to Week 4 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking |
| Secondary | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 8 | Week 2 to Week 8 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking |
| Secondary | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 16 | Week 2 to Week 16 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking |
| Secondary | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 20 | Week 2 to Week 20 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking |
| Secondary | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1 | Week 1 | Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Secondary | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2 | Week 2 | Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
| Secondary | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4 | Week 4 | Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). |
1 to 10 of 214Source ClinicalTrials.gov
See all 214 registered outcomesOutcomes214
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6 | Week 2 to Week 6 | Analysis was based on the Full Analysis Set which included all randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12 | Week 2 to Week 12 | Analysis was based on the Full Analysis Set which included all randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 26 | Week 2 to Week 26 | Analysis was based on the Full Analysis Set which included all randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 4 | Week 2 to Week 4 | Analysis was based on the Full Analysis Set which included all randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 8 | Week 2 to Week 8 | Analysis was based on the Full Analysis Set which included all randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 16 | Week 2 to Week 16 | Analysis was based on the Full Analysis Set which included all randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 20 | Week 2 to Week 20 | Analysis was based on the Full Analysis Set which included all randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1 | Week 1 | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2 | Week 2 | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4 | Week 4 | Analysis was based on randomized participants verified abstinent from smoking since the last visit. | Percentage of Participants | NUMBER |
1 to 10 of 214Source ClinicalTrials.gov
See all 214 outcomesResults by group858
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6 | Placebo | 2.5 | Percentage of Participants | ||
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6 | Nicotine | 5.0 | Percentage of Participants | ||
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12 | Placebo | 1.3 | Percentage of Participants | ||
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12 | Nicotine | 4.0 | Percentage of Participants | ||
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 26 | Placebo | 1.2 | Percentage of Participants | ||
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 26 | Nicotine | 3.4 | Percentage of Participants | ||
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 4 | Placebo | 4.0 | Percentage of Participants | ||
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 4 | Nicotine | 6.7 | Percentage of Participants | ||
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 8 | Placebo | 2.2 | Percentage of Participants | ||
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 8 | Nicotine | 4.5 | Percentage of Participants |
1 to 10 of 858Source ClinicalTrials.gov
See all 858 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 601 | |
| Overall Study | STARTED | Nicotine | 597 | |
| Overall Study | COMPLETED | Placebo | 352 | |
| Overall Study | COMPLETED | Nicotine | 365 | |
| Overall Study | NOT COMPLETED | Placebo | 249 | |
| Overall Study | NOT COMPLETED | Nicotine | 232 |
Source ClinicalTrials.gov
Adverse events120
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo | 26 | 601 | |
| other | Nausea | Gastrointestinal disorders | Nicotine | 59 | 597 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 22 | 601 | |
| other | Nasopharyngitis | Infections and infestations | Nicotine | 35 | 597 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Placebo | 23 | 601 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Nicotine | 35 | 597 | |
| other | Headache | Nervous system disorders | Placebo | 38 | 601 | |
| other | Headache | Nervous system disorders | Nicotine | 48 | 597 | |
| other | Hiccups | Respiratory, thoracic and mediastinal disorders | Placebo | 47 | 601 | |
| other | Hiccups | Respiratory, thoracic and mediastinal disorders | Nicotine | 252 | 597 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Nicotine | ||
| Total, other adverse events | Placebo | 140 | 601 |
| Total, other adverse events | Nicotine | 349 | 597 |
| Total, serious adverse events | Placebo | 14 | 601 |
| Total, serious adverse events | Nicotine | 20 | 597 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30452732 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Nicotine vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02355665
GET https://conductscience.org/api/trials/v1/NCT02355665/registered?page=2