Oral Mucosal Effects In Adult Smokers Associated With Two... | NCT03087786

NCT03087786

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Name	Class
Inflamax Research Incorporated	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nicotine Bitartrate Lozenge 4mg	Drug	Test Product	Nicotine Bitartrate 4mg Lozenge

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
OMI-20 Erythema Subscore Change From Baseline to Day 3	Scale Title: The 20 Item Oral Mucositis Index (OMI-20) The OMI-20 contains a subset of nine items measuring erythema, all are scored from 0 [none] to 3 [severe], and summed for a total possible score of 0-27. A higher score means a worse outcome.	Day 3

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
Nicotine use:
1. 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.
2. 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:
1. 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.
2. Has fixed retainers, orthodontic appliances, or either maxillary and/or mandibular dentures or other appliances which may interfere with the placement of the product.
3. Has current or recurrent disease that could affect the site of application, the action, absorption of the study treatment, or clinical assessment.
4. 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.
5. 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.
6. Has elective dentistry scheduled during the study duration.
Allergy/Intolerance:
1. Has a known or suspected intolerance or hypersensitivity to the study materials (or closely-related compounds) or any of their stated ingredients.
2. Has a known genetic deficiency with an inability to metabolize aspartame or phenylalanine or has been diagnosed with phenylketonuria.
Clinical Study Participation:
1. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study.
2. Previous participation in this study.
Substance abuse:
1. Current or recent (within two years of screening) history of drug or alcohol abuse, misuse, physical or psychological dependence.
2. Demonstrates a positive alcohol breath test.
3. Demonstrates a positive urine drug screen without disclosure of corresponding prescribed concomitant medication(s) at Screening and Study Visit Day 0.
Urine glucose:

a) Positive glucose urine screen.
Personnel:
1. Is an employee of the Sponsor or the study site.
2. Is a member of the same household as another subject in this trial.
Use of all over the counter (OTC) and prescription (Rx) lozenges after starting the study (Day 0 and onward).

Contacts/Locations Module

Name	Affiliation	Role
Frank Lee, MD, CPI	Inflamax Research Incorporated	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Inflamax Research Inc		Newark	New Jersey	07105	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	Nicotine Bitartrate 4mg Lozenge	Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product
FG001	Nicotine Polacrilex 4mg Lozenge	Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Polacrilex 4Mg Lozenge: Active Comparator

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00050 subjects FG00150 subjects
COMPLETED		FG00048 subjects FG00150 subjects
NOT COMPLETED		FG0002 subjects FG0010 subjects

Type	Comment	Reasons
Withdrawal by Subject		FG0002 subjects FG0010 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Nicotine Bitartrate 4mg Lozenge	Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product
BG001	Nicotine Polacrilex 4mg Lozenge

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

MITT: Modified Intent to Treat (no change in any participant was observed)

Posted

Mean

Standard Deviation

score on a scale

Day 3

ID	Title	Description
OG000	Nicotine Bitartrate 4mg Lozenge	Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product
OG001	Nicotine Polacrilex 4mg Lozenge

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nicotine Bitartrate 4mg Lozenge	Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Dr. Abraham Varghese	Niconovum USA	336-741-2315		varghea@rjrt.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	May 17, 2017	Aug 28, 2018	SAP_000.pdf
Prot	Yes	No	No	Study Protocol	Feb 17, 2017	Oct 1, 2018	Prot_001.pdf

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

ID	Term
D061485	Tobacco Use Cessation Devices

ID	Term
D013812	Therapeutics

Masking Info

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

Nicotine Polacrilex 4Mg Lozenge: Active Comparator

EG0008 events8 affected49 at risk

EG0012 events2 affected50 at risk