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

NCT03087786 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 2016-NBTL-S-005
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (4)

• OMI-20 Total Score Change From Baseline to Day 3

  * Scale Title: The 20 Item Oral Mucositis Index (OMI-20) * The OMI-20 consists of nine items measuring erythema, nine measuring ulceration, one measuring atrophy, and one measuring edema; all are scored from 0 \[none\] to 3 \[severe\] and summed for a total possible score of 0-60. * A higher score means a worse outcome.

  Day 3

• OMI-20 Total Score Change From Baseline to Day 7

  * Scale Title: The 20 Item Oral Mucositis Index (OMI-20) * The OMI-20 consists of nine items measuring erythema, nine measuring ulceration, one measuring atrophy, and one measuring edema; all are scored from 0 \[none\] to 3 \[severe\] and summed for a total possible score of 0-60. * A higher score means a worse outcome.

  Day 7

• OMI-20 Total Score Change From Baseline to Day 14

  * Scale Title: The 20 Item Oral Mucositis Index (OMI-20) * The OMI-20 consists of nine items measuring erythema, nine measuring ulceration, one measuring atrophy, and one measuring edema; all are scored from 0 \[none\] to 3 \[severe\] and summed for a total possible score of 0-60. * A higher score means a worse outcome.

  Day 14

• OMI-20 Total Score Change From Baseline to Day 21

  * Scale Title: The 20 Item Oral Mucositis Index (OMI-20) * The OMI-20 consists of nine items measuring erythema, nine measuring ulceration, one measuring atrophy, and one measuring edema; all are scored from 0 \[none\] to 3 \[severe\] and summed for a total possible score of 0-60. * A higher score means a worse outcome.

  Day 21

Secondary Outcomes (11)

• OMI-20 Erythema Subscore Change From Baseline to Day 3

  Day 3

• OMI-20 Erythema Subscore Change From Baseline to Day 7

  Day 7

• OMI-20 Erythema Subscore Change From Baseline to Day 14

  Day 14

• OMI-20 Erythema Subscore Change From Baseline to Day 21

  Day 21

• OMI-20 Ulcer Subscore Change From Baseline to Day 3

  Day 3

Study Arms (2)

Nicotine Bitartrate 4mg Lozenge

EXPERIMENTAL

Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days

Drug: Nicotine Bitartrate Lozenge 4mg

Nicotine Polacrilex 4mg Lozenge

ACTIVE COMPARATOR

Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days

Drug: Nicotine Polacrilex 4Mg Lozenge

Interventions

Nicotine Bitartrate Lozenge 4mg DRUG

Test Product

Also known as: Test Product

Nicotine Bitartrate 4mg Lozenge

Nicotine Polacrilex 4Mg Lozenge DRUG

Active Comparator

Also known as: Nicorette Lozenge 4mg

Nicotine Polacrilex 4mg Lozenge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential subjects who meet the following criteria at Screening may be included in the study.
• Sex and Age: Males and females aged at least 18 years and older.
• Informed of the nature of the study and have agreed to and are able to read, review, and sign the informed consent document prior to commencing any study specific procedures. The informed consent document will be written in English, therefore the volunteer must have the ability to read and communicate in English.
• Must have smoked at least 10 cigarettes per day for the previous 12 months prior to screening.
• Must smoke first cigarette within 30 minutes of waking up.
• Must be motivated to quit smoking upon enrollment into the study.
• Contraception: Females of childbearing potential who have been, in the opinion of the Investigator, practicing a reliable method of contraception for at least two months prior to study participation and must agree to remain on an acceptable method of contraception while participating in the study period using the study medication. Acceptable methods of contraception are hormonal birth control, intrauterine device, double barrier methods, vasectomized partner or abstinence.
• Females of childbearing potential will be required to undergo a serum (Screening) and urine (Day 0) pregnancy test (must be negative).
• Females of non-childbearing potential must be surgically sterile for at least three months prior to Screening or post-menopausal for at least two years.
• General health: All study participants must have good general health and no impairment that would impede or affect ability to participate in the study as deemed acceptable by the Investigator.
• Compliance: All study participants must understand and be willing to comply with all study procedures and restrictions.
• Consent: All study participants must demonstrate willingness to participate as evidenced by voluntary written informed consent and must have received a signed and dated copy of the informed consent form.

You may not qualify if:

• Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
• Nicotine use:
• Is unable/unwilling to stop using forms of tobacco (e.g., traditional cigarettes, chewing tobacco, nicotine gels, cigars, snuff tobacco, nicotine patch and electronic cigarettes) for the duration of the study.
• Is unable/unwilling to stop using other nicotine replacement therapy products throughout the duration of the study.
• Disease: Has a medical history, which in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results, e.g., known history of heart disease, recent myocardial infarction or cerebrovascular accident (i.e., within 12 weeks prior to enrollment), unstable angina, severe cardiac arrhythmia, diabetes or peptic ulcer.
• Demonstrates a reactive screen for Hepatitis B surface antigens, hepatitis C antibody, or HIV antibody.
• Oral condition:
• Has history of oral surgery (including extractions) within four weeks of screening, operative dental work within seven days of screening, or a presence of any clinically significant oral pathology (as determined by an oral health professional - dentist or dental hygienist) including lesions, sores or inflammation of the mouth which would interfere with study assessments or confound the results.
• Has fixed retainers, orthodontic appliances, or either maxillary and/or mandibular dentures or other appliances which may interfere with the placement of the product.
• Has current or recurrent disease that could affect the site of application, the action, absorption of the study treatment, or clinical assessment.
• Has severe gingivitis, periodontitis or rampant caries (extensive dental decay, i.e., big/deep cavities, in many teeth), as diagnosed by an oral health professional- dentist or dental hygienist.
• Has the presence of oral or peri-oral ulceration including herpetic lesions at screening (subjects with these lesions may be re-examined at a subsequent appointment and may be able to be admitted at a later date if the ulceration or herpetic lesion heals) or Study Visit Day 0.
• Has elective dentistry scheduled during the study duration.
• Allergy/Intolerance:
• Has a known or suspected intolerance or hypersensitivity to the study materials (or closely-related compounds) or any of their stated ingredients.

Sponsors & Collaborators

• Niconovum USA: lead
• Inflamax Research Incorporated: collaborator

Study Sites (1)

Inflamax Research Inc

Newark, New Jersey, 07105, United States

Location

MeSH Terms

Interventions

Tobacco Use Cessation Devices

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Abraham Varghese
• Organization: Niconovum USA

varghea@rjrt.com

336-741-2315

Study Officials

• Frank Lee, MD, CPI

  Inflamax Research Incorporated

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 23, 2017
• Study Start: March 21, 2017
• Primary Completion: August 13, 2017
• Study Completion: August 13, 2017
• Last Updated: January 11, 2021
• Results First Posted: January 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)