Trial Outcomes & Findings for Oral Mucosal Effects In Adult Smokers Associated With Two Nicotine Lozenge Formulations (NCT NCT03087786)

NCT ID: NCT03087786

Last Updated: 2021-01-11

Results Overview

* 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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 100 participants
• Primary outcome timeframe: Day 3
• Results posted on: 2021-01-11

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	50	50
Overall Study COMPLETED	48	50
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	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	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
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Nicotine Bitartrate 4mg Lozenge n=49 Participants Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product	Nicotine Polacrilex 4mg Lozenge n=50 Participants Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Polacrilex 4Mg Lozenge: Active Comparator	Total n=99 Participants Total of all reporting groups
Age, Continuous	39.1 years STANDARD_DEVIATION 13.53 • n=5 Participants	39.0 years STANDARD_DEVIATION 10.94 • n=7 Participants	39.1 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	31 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants	43 Participants n=7 Participants	84 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	30 Participants n=5 Participants	39 Participants n=7 Participants	69 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	11 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	49 Participants n=5 Participants	50 Participants n=7 Participants	99 Participants n=5 Participants
Number of Particiapnts with OMI-20 Score of 0.00	49 participants n=5 Participants	50 participants n=7 Participants	99 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 3

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

• 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.

Outcome measures

Measure	Nicotine Bitartrate 4mg Lozenge n=47 Participants Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product	Nicotine Polacrilex 4mg Lozenge n=49 Participants Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Polacrilex 4Mg Lozenge: Active Comparator
OMI-20 Total Score Change From Baseline to Day 3	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Day 7

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

• 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.

Outcome measures

Measure	Nicotine Bitartrate 4mg Lozenge n=49 Participants Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product	Nicotine Polacrilex 4mg Lozenge n=50 Participants Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Polacrilex 4Mg Lozenge: Active Comparator
OMI-20 Total Score Change From Baseline to Day 7	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Day 14

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

• 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.

Outcome measures

Measure	Nicotine Bitartrate 4mg Lozenge n=48 Participants Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product	Nicotine Polacrilex 4mg Lozenge n=49 Participants Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Polacrilex 4Mg Lozenge: Active Comparator
OMI-20 Total Score Change From Baseline to Day 14	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Day 21

Population: MITT: Modified Intent to Treat (no change in any participant was observed in the Nicotine Bitartrate arm)

• 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.

Outcome measures

Measure	Nicotine Bitartrate 4mg Lozenge n=47 Participants Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product	Nicotine Polacrilex 4mg Lozenge n=49 Participants Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Polacrilex 4Mg Lozenge: Active Comparator
OMI-20 Total Score Change From Baseline to Day 21	0.00 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.20

SECONDARY outcome

Timeframe: Day 3

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

• 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.

Outcome measures

Measure	Nicotine Bitartrate 4mg Lozenge n=47 Participants Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product	Nicotine Polacrilex 4mg Lozenge n=49 Participants Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Polacrilex 4Mg Lozenge: Active Comparator
OMI-20 Erythema Subscore Change From Baseline to Day 3	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Day 7

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

• 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.

Outcome measures

Measure	Nicotine Bitartrate 4mg Lozenge n=49 Participants Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product	Nicotine Polacrilex 4mg Lozenge n=50 Participants Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Polacrilex 4Mg Lozenge: Active Comparator
OMI-20 Erythema Subscore Change From Baseline to Day 7	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Day 14

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

• 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.

Outcome measures

Measure	Nicotine Bitartrate 4mg Lozenge n=48 Participants Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product	Nicotine Polacrilex 4mg Lozenge n=49 Participants Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Polacrilex 4Mg Lozenge: Active Comparator
OMI-20 Erythema Subscore Change From Baseline to Day 14	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Day 21

Population: Modified Intent to Treat (no change in any participant was observed in the Nicotine Bitartrate arm)

• 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.

Outcome measures

Measure	Nicotine Bitartrate 4mg Lozenge n=47 Participants Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product	Nicotine Polacrilex 4mg Lozenge n=49 Participants Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Polacrilex 4Mg Lozenge: Active Comparator
OMI-20 Erythema Subscore Change From Baseline to Day 21	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.14

SECONDARY outcome

Timeframe: Day 3

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

• Scale Title: The 20 Item Oral Mucositis Index (OMI-20)
• The OMI-20 contains a subset of nine items measuring ulcers, 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.

Outcome measures

Measure	Nicotine Bitartrate 4mg Lozenge n=47 Participants Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product	Nicotine Polacrilex 4mg Lozenge n=49 Participants Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Polacrilex 4Mg Lozenge: Active Comparator
OMI-20 Ulcer Subscore Change From Baseline to Day 3	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Day 7

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

• Scale Title: The 20 Item Oral Mucositis Index (OMI-20)
• The OMI-20 contains a subset of nine items measuring ulcers, 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.

Outcome measures

Measure	Nicotine Bitartrate 4mg Lozenge n=49 Participants Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product	Nicotine Polacrilex 4mg Lozenge n=50 Participants Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Polacrilex 4Mg Lozenge: Active Comparator
OMI-20 Ulcer Subscore Change From Baseline to Day 7	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Day 14

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

• Scale Title: The 20 Item Oral Mucositis Index (OMI-20)
• The OMI-20 contains a subset of nine items measuring ulcers, 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.

Outcome measures

Measure	Nicotine Bitartrate 4mg Lozenge n=48 Participants Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product	Nicotine Polacrilex 4mg Lozenge n=49 Participants Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Polacrilex 4Mg Lozenge: Active Comparator
OMI-20 Ulcer Subscore Change From Baseline to Day 14	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Day 21

Population: Modified Intent to Treat (no change in any participant was observed in the Nicotine Bitartrate arm)

• Scale Title: The 20 Item Oral Mucositis Index (OMI-20)
• The OMI-20 contains a subset of nine items measuring ulcers, 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.

Outcome measures

Measure	Nicotine Bitartrate 4mg Lozenge n=47 Participants Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product	Nicotine Polacrilex 4mg Lozenge n=49 Participants Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Polacrilex 4Mg Lozenge: Active Comparator
OMI-20 Ulcer Subscore Change From Baseline to Day 21	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.14

SECONDARY outcome

Timeframe: Day 21

Population: Modified Intent to Treat

Count of the number of participants with Adverse Events.

Outcome measures

Measure	Nicotine Bitartrate 4mg Lozenge n=49 Participants Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product	Nicotine Polacrilex 4mg Lozenge n=50 Participants Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Polacrilex 4Mg Lozenge: Active Comparator
Number of Participants With Adverse Events (AEs)	18 Participants	12 Participants

SECONDARY outcome

Timeframe: Day 21

Population: Modified Intent to Treat

Count of the number of participants with Serious Adverse Events

Outcome measures

Measure	Nicotine Bitartrate 4mg Lozenge n=49 Participants Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product	Nicotine Polacrilex 4mg Lozenge n=50 Participants Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Polacrilex 4Mg Lozenge: Active Comparator
Number of Participants With Serious Adverse Events (SAEs)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 21

Population: Modified Intent to Treat

Count of the number of participants who discontinued due to Adverse Events.

Outcome measures

Measure	Nicotine Bitartrate 4mg Lozenge n=49 Participants Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product	Nicotine Polacrilex 4mg Lozenge n=50 Participants Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Polacrilex 4Mg Lozenge: Active Comparator
Number of Participants Who Discontinued Due to Adverse Events (AEs)	0 Participants	0 Participants

Adverse Events

Nicotine Bitartrate 4mg Lozenge

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Nicotine Polacrilex 4mg Lozenge

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nicotine Bitartrate 4mg Lozenge n=49 participants at risk Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Bitartrate Lozenge 4mg: Test Product	Nicotine Polacrilex 4mg Lozenge n=50 participants at risk Nicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Nicotine Polacrilex 4Mg Lozenge: Active Comparator
Respiratory, thoracic and mediastinal disorders Hiccups	16.3% 8/49 • Number of events 8 • 24 days	4.0% 2/50 • Number of events 2 • 24 days
Gastrointestinal disorders Nausea	10.2% 5/49 • Number of events 6 • 24 days	4.0% 2/50 • Number of events 2 • 24 days
Nervous system disorders Headache	0.00% 0/49 • 24 days	6.0% 3/50 • Number of events 3 • 24 days
Gastrointestinal disorders Dispepsia	4.1% 2/49 • Number of events 2 • 24 days	0.00% 0/50 • 24 days
Nervous system disorders Dizziness	4.1% 2/49 • Number of events 2 • 24 days	0.00% 0/50 • 24 days
Infections and infestations Upper Respiratory Tract Infection	2.0% 1/49 • Number of events 1 • 24 days	4.0% 2/50 • Number of events 2 • 24 days
Gastrointestinal disorders Diarrhorea	2.0% 1/49 • Number of events 1 • 24 days	2.0% 1/50 • Number of events 1 • 24 days
Infections and infestations Pharyngitis Streptococcal	2.0% 1/49 • Number of events 1 • 24 days	0.00% 0/50 • 24 days
Infections and infestations Urinary Tract Infection	2.0% 1/49 • Number of events 1 • 24 days	0.00% 0/50 • 24 days
Musculoskeletal and connective tissue disorders Myalgia	2.0% 1/49 • Number of events 1 • 24 days	2.0% 1/50 • Number of events 1 • 24 days
Nervous system disorders Presyncope	2.0% 1/49 • Number of events 1 • 24 days	0.00% 0/50 • 24 days
Psychiatric disorders Anxiety	2.0% 1/49 • Number of events 1 • 24 days	0.00% 0/50 • 24 days
Respiratory, thoracic and mediastinal disorders Throat Irritation	2.0% 1/49 • Number of events 1 • 24 days	0.00% 0/50 • 24 days
General disorders Application Site Warmth	0.00% 0/49 • 24 days	2.0% 1/50 • Number of events 1 • 24 days
General disorders Vessel Puncture Site Bruise	0.00% 0/49 • 24 days	2.0% 1/50 • Number of events 1 • 24 days
Psychiatric disorders Insomnia	0.00% 0/49 • 24 days	2.0% 1/50 • Number of events 1 • 24 days

Additional Information

Dr. Abraham Varghese

Niconovum USA

Phone: 336-741-2315

Email: varghea@rjrt.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor and the PI have a Confidentiality Agreement stating: * Each Party shall not disclose Confidential Information publicly or to any third party in an unauthorized manner. * Each Party's obligations of confidentiality, non-disclosure and limited use imposed by this Agreement shall not apply to information or items that are required to be disclosed by governmental authority or by judicial process.
• Publication restrictions are in place

Restriction type: OTHER