At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 100 enrolled
Drug / intervention
Nicotine Bitartrate Lozenge 4mg +1 moredrug
Likely dose
Nicotine Bitartrate Lozenge 4mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Parallel-Group, Assessor Blind Study To Evaluate Oral Mucosal Effects In Healthy Adult Smokers Associated With 3 Week Use Of Nicotine Bi-tartrate 4mg Mint Lozenges Relative To The Use Of Nicotine Polacrilex 4mg Mint Lozenges
In Brief
A Phase 1 clinical trial evaluating Nicotine Bitartrate Lozenge 4mg and Nicotine Polacrilex 4Mg Lozenge for Safety Issues. Completed, enrolled 100 participants across 1 site.
Detailed Summary
To study the oral mucosal effects in adult smokers associated with the use of two Nicotine Lozenge formulations.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSafety Issues
CountriesUnited States
CollaboratorsInflamax Research Incorporated
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartMar 2017
First PostedMar 2017
Primary CompletionAug 2017
TodayJul 2026
First PostedMar 23, 2017
Enrollment StartMar 21, 2017
Primary CompletionAug 13, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.3 years ago
Interventions
Nicotine Bitartrate Lozenge 4mgdrug
Test Product
Nicotine Polacrilex 4Mg Lozengedrug
Active Comparator