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

NCT03087786 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-01-11

Study results available
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Summary

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

Conditions

  • Safety Issues

Interventions

DRUG

Nicotine Bitartrate Lozenge 4mg

Test Product

DRUG

Nicotine Polacrilex 4Mg Lozenge

Active Comparator

Sponsors & Collaborators

  • Inflamax Research Incorporated

    collaborator INDUSTRY

  • Niconovum USA

    lead INDUSTRY

Principal Investigators

  • Frank Lee, MD, CPI · Inflamax Research Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-21
Primary Completion
2017-08-13
Completion
2017-08-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03087786 on ClinicalTrials.gov