NCT03087786

Oral Mucosal Effects In Adult Smokers Associated With Two Nicotine Lozenge Formulations

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Niconovum USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To study the oral mucosal effects in adult smokers associated with the use of two Nicotine Lozenge formulations.

Detailed description

To assess the oral mucosal health associated with 3 weeks of use of test product, Nicotine Bitartrate 4 mg mint lozenge, relative to a reference product, Nicorette® \[Nicotine Polacrilex\] 4 mg mint lozenge, in healthy adult smokers motivated to quit smoking. To evaluate the safety and tolerability of Nicotine Bitartrate 4 mg mint lozenge and Nicorette® \[Nicotine Polacrilex\] 4 mg mint lozenge in this subject population.

Conditions

• Safety Issues

Interventions

Type	Name	Description
DRUG	Nicotine Bitartrate Lozenge 4mg	Test Product
DRUG	Nicotine Polacrilex 4Mg Lozenge	Active Comparator

Timeline

• Start date: 2017-03-21
• Primary completion: 2017-08-13
• Completion: 2017-08-13
• First posted: 2017-03-23
• Last updated: 2021-01-11
• Results posted: 2021-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study