Safety IssuesPhase 1NCT03087786
Oral Mucosal Effects In Adult Smokers Associated With Two Nicotine Lozenge Formulations
A Phase 1 study testing Nicotine Bitartrate Lozenge 4mg and Nicotine Polacrilex 4Mg Lozenge in people with Safety Issues, run by Niconovum USA at 1 site in United States.
Trial summary
To study the oral mucosal effects in adult smokers associated with the use of two Nicotine Lozenge formulations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- Nicotine Bitartrate Lozenge 4mg and Nicotine Polacrilex 4Mg Lozenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2017to 13 Aug 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Has a known genetic deficiency with an inability to metabolize aspartame or phenylalanine or has been diagnosed with phenylketonuria.
- Clinical Study Participation:
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study.
- Previous participation in this study.
- Substance abuse:
- Current or recent (within two years of screening) history of drug or alcohol abuse, misuse, physical or psychological dependence.
- Demonstrates a positive alcohol breath test.
- Demonstrates a positive urine drug screen without disclosure of corresponding prescribed concomitant medication(s) at Screening and Study Visit Day 0.
- Urine glucose:
- Positive glucose urine screen.
- Personnel:
- Is an employee of the Sponsor or the study site.
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
To study the oral mucosal effects in adult smokers associated with the use of two Nicotine Lozenge formulations.
Read the 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
- Being tested
- Nicotine Bitartrate Lozenge 4mg, Nicotine Polacrilex 4Mg Lozenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Bitartrate Lozenge 4mgDrug
Also called Test Product
Test Product
Nicotine Polacrilex 4Mg LozengeDrug
Also called Nicorette Lozenge 4mg
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Bitartrate 4mg Lozenge | Experimental | Nicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days Receives: 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 Receives: Drug: Nicotine Polacrilex 4Mg Lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 21
Secondary outcomes (11)
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.
Measured: Day 3
OMI-20 Erythema Subscore Change From Baseline to Day 7
- 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.
Measured: Day 7
OMI-20 Erythema Subscore Change From Baseline to Day 14
- 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.
Measured: Day 14
OMI-20 Erythema Subscore Change From Baseline to Day 21
- 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.
Measured: Day 21
OMI-20 Ulcer 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 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.
Measured: Day 3
OMI-20 Ulcer Subscore Change From Baseline to Day 7
- 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.
Measured: Day 7
OMI-20 Ulcer Subscore Change From Baseline to Day 14
- 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.
Measured: Day 14
OMI-20 Ulcer Subscore Change From Baseline to Day 21
- 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.
Measured: Day 21
Number of Participants With Adverse Events (AEs)
Count of the number of participants with Adverse Events.
Measured: Day 21
Number of Participants With Serious Adverse Events (SAEs)
Count of the number of participants with Serious Adverse Events
Measured: Day 21
Number of Participants Who Discontinued Due to Adverse Events (AEs)
Count of the number of participants who discontinued due to Adverse Events.
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start21 Mar 2017
- Primary completion13 Aug 2017
- Study completion13 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niconovum USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inflamax Research Incorporated
- Responsible party
- Sponsor
- Investigators
- Frank Lee, MD, CPI, Principal investigator, Inflamax Research Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087786
- Sponsor's protocol ID
- 2016-NBTL-S-005
- Status last verified
- Jan 2021
- First submitted
- 17 Mar 2017
- Last updated
- 11 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03087786
- Acronym / sponsor ID
- 2016-NBTL-S-005
- Conditions
- Safety Issues
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Niconovum USAIndustry (pharma, biotech, devices)
- Collaborators
- Inflamax Research Incorporated
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 13 Aug 2017 (actual)
- Study completion
- 13 Aug 2017 (actual)
- First posted
- 23 Mar 2017 (actual)
- Results
- Posted 11 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine Bitartrate 4mg Lozenge | Experimental | Drug: Nicotine Bitartrate Lozenge 4mgNicotine Bitartrate Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days |
| Nicotine Polacrilex 4mg Lozenge | Active comparator | Drug: Nicotine Polacrilex 4Mg LozengeNicotine Polacrilex Lozenge 4mg. Take 1 lozenge every 1-2 hours, as needed for 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (29 listed)
- Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
- Nicotine use:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Bitartrate Lozenge 4mgAlso: Test ProductTest Product | Drug | Nicotine Bitartrate 4mg Lozenge |
| Nicotine Polacrilex 4Mg LozengeAlso: Nicorette Lozenge 4mgActive Comparator | Drug | Nicotine Polacrilex 4mg Lozenge |
Primary outcome
OMI-20 Total Score Change From Baseline to Day 3
Time frame: 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.
OMI-20 Total Score Change From Baseline to Day 7
Time frame: 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.
OMI-20 Total Score Change From Baseline to Day 14
Time frame: 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.
OMI-20 Total Score Change From Baseline to Day 21
Time frame: 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.
11 secondary outcomes
OMI-20 Erythema Subscore Change From Baseline to Day 3
Time frame: Day 3
OMI-20 Erythema Subscore Change From Baseline to Day 7
Time frame: Day 7
OMI-20 Erythema Subscore Change From Baseline to Day 14
Time frame: Day 14
OMI-20 Erythema Subscore Change From Baseline to Day 21
Time frame: Day 21
OMI-20 Ulcer Subscore Change From Baseline to Day 3
Time frame: Day 3
OMI-20 Ulcer Subscore Change From Baseline to Day 7
Time frame: Day 7
OMI-20 Ulcer Subscore Change From Baseline to Day 14
Time frame: Day 14
OMI-20 Ulcer Subscore Change From Baseline to Day 21
Time frame: Day 21
Number of Participants With Adverse Events (AEs)
Time frame: Day 21
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Day 21
Number of Participants Who Discontinued Due to Adverse Events (AEs)
Time frame: Day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Lee, MD, CPI principal investigator
Inflamax Research Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nicotine Bitartrate Lozenge 4mg and Nicotine Polacrilex 4Mg Lozenge in people with Safety Issues, run by Niconovum USA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OMI-20 Total Score Change From Baseline to Day 3 (time frame: Day 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021.