Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02355665 | Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy | PHASE3 | COMPLETED | 1,198 | — | — | Jan 31, 2015 | Feb 10, 2016 | Jan 8, 2019 | 8 | United States |
| NCT01321931 | Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products | PHASE1 | COMPLETED | 50 | — | — | Feb 1, 2011 | Jun 1, 2011 | Jul 10, 2012 | 1 | Sweden |
| NCT01478230 | An Exploratory Study Comparing Two Nicotine Inhalers | EARLY_PHASE1 | COMPLETED | 36 | — | — | Nov 1, 2011 | Dec 1, 2011 | Jul 10, 2012 | 1 | Sweden |
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma within the last dosing interval, measured in nanograms/milliliter (ng/mL)
Average Nicotine Plasma Concentration (Cav) within the last dosing interval
Area under the nicotine plasma concentration-vs.-time curve during the last dosing interval (AUCt)
Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, measured in nanograms/milliliter (ng/mL)
The average concentration of nicotine in the blood. \* The dosing interval (τ) in this study will be one (1) hour. Consequently, Cav will have the same value as AUCτ (but with a different unit), since Cav is calculated as AUCτ divided by τ. Therefore Cav will not be displayed in results, only AUCτ.
AUCτ is the area under the plasma concentration-vs.-time curve during the last dosing interval and is a measure of how much of the drug reaches the person's bloodstream. The Area Under the Curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period. The area under this curve is calculated as hour \* nanograms (ng) per milliliter (mL).
| Arm | Type | Description |
|---|---|---|
| Nicotine | EXPERIMENTAL | Nicotine Spray |
| Placebo | PLACEBO_COMPARATOR | Placebo to match Nicotine spray |
| NRT 60 | EXPERIMENTAL | A 6 mg dose of an experimental Nicotine Replacement Therapy (NRT) given every hour for 11 hours, with a 36-hour washout between visits |
| NFG 60 | ACTIVE_COMPARATOR | A 4 mg dose of a marketed Nicotine Fruit Gum (NFG) given every hour for 11 hours, with a 36-hour washout between visits |
| NRT 90 | EXPERIMENTAL | A 6 mg dose of NRT given every 90 minutes for 10.5 hours, with a 36-hour washout between visits |
| NFG 90 | ACTIVE_COMPARATOR | A 4 mg dose of NFG given every 90 minutes for 10.5 hours, with a 36-hour washout between visits |
| NIQ 60 | ACTIVE_COMPARATOR | A 4 mg dose of marketed nicotine mint lozenge (NIQ), given every hour for 11 hours, with a 36-hour washout between visits |
| N1/3-I5 | EXPERIMENTAL | 5 mg Inhalation during 10 minutes every hour for 11 hours with a puff frequency of four puffs per minute, with a 36-hour washout between visits |
| NX-I10 | ACTIVE_COMPARATOR | 10 mg Inhalation during 10 minutes every hour for 11 hours with a puff frequency of four puffs per minute, with a 36-hour washout between visits. |
| Name | Type | Description |
|---|---|---|
| Nicotine Spray | DRUG | Nicotine Spray |
| Placebo | DRUG | Placebo to match nicotine spray |
| Nicotine | DRUG | 6 mg experimental Nicotine Replacement Therapy (NRT) |
Inclusion Criteria: Subjects must be males or females 18-85 years of age who currently smoke cigarettes daily and are willing to stop smoking Exclusion Criteria: History of cardiovascular disease, stomach ulcer or diabetes unless physician's written approval is obtained. Use of other forms of to...