Oral Tolerability Of Two Nicotine Dosage Forms

A Randomized, Open Label Study to Evaluate the Oral Tolerability of a Nicotine Prototype

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00682461

Enrollment

200

Registered

2008-05-22

Start date

2007-09-30

Completion date

2009-01-31

Last updated

2013-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer Smokers

Keywords

Nicotine Tolerability NRT

Brief summary

This study is to evaluate the oral tolerability of a nicotine prototype

Interventions

DRUGNicotine

Marketed nicotine replacement therapy formulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Age:Males and females aged at least 18 years. * Smoking status: a.Must have smoked 5 to 20 cigarettes per day for the previous 12 months. b.Must be motivated to quit smoking upon randomization into 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. * Oral health:Must have good oral health (in the opinion of the Investigator) with no clinically significant oral pathology at screening. * General health:Must have good general health (in the opinion of the Investigator) with no clinically significant and relevant abnormalities of medical history on physical examination at screening. * Compliance:Understands and is willing, able and likely to comply with all study procedures and restrictions. * Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.

Exclusion criteria

* Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. Females of child-bearing potential will be required to undergo a urine pregnancy test which must be negative. * Breast-feeding:Women who are breast-feeding. * Nicotine use: a.Is unable/unwilling to stop using forms of tobacco. b.Is unable/unwilling to stop using other nicotine replacement therapy. * 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 the first study session), unstable angina, severe cardiac arrhythmia, diabetes or peptic ulcer. * Oral condition: a.Has history of oral surgery (including extractions) within four weeks, operative dental work within seven days, or a presence of any clinically significant oral pathology (as determined by the Investigator) including lesions, sores or inflammation which would interfere with assessments. b.Has fixed retainers, orthodontic appliances, or either maxillary and/or mandibular dentures or other appliances which may interfere with the placement or wearing of the product. c.Has current or recurrent disease that could affect the site of application, the action, absorption or disposition of the study treatment, or clinical assessment. d.Has severe gingivitis, periodontitis or rampant caries, as diagnosed by the investigator. e.Has the presence of oral or peri-oral ulceration including herpetic lesions at the time of baseline (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). f.Has elective dentistry scheduled during the study duration. * Allergy/Intolerance: a.Has a known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. b.Presence of a genetic deficiency with an inability to metabolize aspartame or phenylalanine or has been diagnosed with phenylketonuria. * Clinical Study/Experimental medication: a.Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study. b.Previous participation in this study. * Substance abuse: a) Current or recent (within two year of screening) alcohol or other substance abuse. b) Positive alcohol breath screen. c) Positive urine drug screen for cannabinoids, amphetamine, cocaine, ecstasy, methamphetamine or morphine. * Urine glucose:Positive glucose urine screen. * Personnel: a.Is an employee of the sponsor or the study site. b.Is a member of the same household as another subject in this trial.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 1	From baseline to Week 1	Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands
Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 6	From baseline to Week 6	Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands
Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 12	From baseline to Week 12	Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands
Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 14	From baseline to Week 14	Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands

Secondary

Measure	Time frame	Description
Percentage of Participants With Adverse Events	From baseline to Week 14	Adverse Event=any untoward medical occurrence in a subject following administration of an investigational product, which did not necessarily have a causal relationship with this treatment. Serious Adverse Event=any untoward medical occurrence that at any dose; results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect

Participant flow

Recruitment details

Participants were recruited at one clinical site in the US.

Participants by arm

Arm	Count
Nicotine Mouth Strip (2.5 mg) Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day	100
Nicotine Lozenge (2.0 mg) Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day	100
Total	200

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	5	7
Overall Study	Lost to Follow-up	8	5
Overall Study	Withdrawal by Subject	12	19

Baseline characteristics

Characteristic	Nicotine Mouth Strip (2.5 mg)	Nicotine Lozenge (2.0 mg)	Total
Age Continuous	42.32 Years STANDARD_DEVIATION 11.79	42.84 Years STANDARD_DEVIATION 12.34	42.58 Years STANDARD_DEVIATION 12.042
Sex: Female, Male Female	62 Participants	63 Participants	125 Participants
Sex: Female, Male Male	38 Participants	37 Participants	75 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	69 / 100	75 / 100
serious Total, serious adverse events	0 / 100	1 / 100

Outcome results

Primary

Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 1

Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands

Time frame: From baseline to Week 1