Trial Outcomes & Findings for Oral Tolerability Of Two Nicotine Dosage Forms (NCT NCT00682461)

NCT ID: NCT00682461

Last Updated: 2013-03-01

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 200 participants
• Primary outcome timeframe: From baseline to Week 1
• Results posted on: 2013-03-01

Participant Flow

Participants were recruited at one clinical site in the US.

Participant milestones

Measure	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	Nicotine Lozenge (2.0 mg) Prticipants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
Overall Study STARTED	100	100
Overall Study COMPLETED	75	69
Overall Study NOT COMPLETED	25	31

Reasons for withdrawal

Measure	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	Nicotine Lozenge (2.0 mg) Prticipants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
Overall Study Adverse Event	5	7
Overall Study Lost to Follow-up	8	5
Overall Study Withdrawal by Subject	12	19

Baseline Characteristics

Oral Tolerability Of Two Nicotine Dosage Forms

Baseline characteristics by cohort

Measure	Nicotine Mouth Strip (2.5 mg) n=100 Participants Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day	Nicotine Lozenge (2.0 mg) n=100 Participants Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day	Total n=200 Participants Total of all reporting groups
Age Continuous	42.32 Years STANDARD_DEVIATION 11.79 • n=5 Participants	42.84 Years STANDARD_DEVIATION 12.34 • n=7 Participants	42.58 Years STANDARD_DEVIATION 12.042 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	63 Participants n=7 Participants	125 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	37 Participants n=7 Participants	75 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to Week 1

Population: Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.

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

Outcome measures

Measure	Nicotine Mouth Strip (2.5 mg) n=86 Participants Participants were instructed to take 2.5 mg Nicotine Mouth strip, not exceeding a maximum limit of 15 per day	Nicotine Lozenge (2.0 mg) n=87 Participants Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 1	2.3 Percentage	12.6 Percentage

PRIMARY outcome

Timeframe: From baseline to Week 6

Population: Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.

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

Outcome measures

Measure	Nicotine Mouth Strip (2.5 mg) n=76 Participants Participants were instructed to take 2.5 mg Nicotine Mouth strip, not exceeding a maximum limit of 15 per day	Nicotine Lozenge (2.0 mg) n=73 Participants Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 6	6.6 Percentage	12.3 Percentage

PRIMARY outcome

Timeframe: From baseline to Week 12

Population: Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.

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

Outcome measures

Measure	Nicotine Mouth Strip (2.5 mg) n=75 Participants Participants were instructed to take 2.5 mg Nicotine Mouth strip, not exceeding a maximum limit of 15 per day	Nicotine Lozenge (2.0 mg) n=70 Participants Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 12	6.7 Percentage	7.1 Percentage

PRIMARY outcome

Timeframe: From baseline to Week 14

Population: Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.

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

Outcome measures

Measure	Nicotine Mouth Strip (2.5 mg) n=82 Participants Participants were instructed to take 2.5 mg Nicotine Mouth strip, not exceeding a maximum limit of 15 per day	Nicotine Lozenge (2.0 mg) n=87 Participants Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 14	2.4 Percentage	8.0 Percentage

SECONDARY outcome

Timeframe: From baseline to Week 14

Population: Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.

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

Outcome measures

Measure	Nicotine Mouth Strip (2.5 mg) n=100 Participants Participants were instructed to take 2.5 mg Nicotine Mouth strip, not exceeding a maximum limit of 15 per day	Nicotine Lozenge (2.0 mg) n=100 Participants Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
Percentage of Participants With Adverse Events Oral Treatment Emergent Adverse Events	27 Percentage	44 Percentage
Percentage of Participants With Adverse Events Non-oral Treatment Emergent Adverse Events	58 Percentage	60 Percentage
Percentage of Participants With Adverse Events Serious Adverse Events	0 Percentage	1 Percentage
Percentage of Participants With Adverse Events Death	0 Percentage	0 Percentage

Adverse Events

Nicotine Mouth Strip (2.5 mg)

Serious events: 0 serious events

Other events: 69 other events

Deaths: 0 deaths

Nicotine Lozenge (2.0 mg)

Serious events: 1 serious events

Other events: 75 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nicotine Mouth Strip (2.5 mg) n=100 participants at risk Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day	Nicotine Lozenge (2.0 mg) n=100 participants at risk Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum of 15 per day
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.00% 0/100 • From baseline to Week 14 All adverse events	1.0% 1/100 • Number of events 1 • From baseline to Week 14 All adverse events

Other adverse events

Measure	Nicotine Mouth Strip (2.5 mg) n=100 participants at risk Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day	Nicotine Lozenge (2.0 mg) n=100 participants at risk Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum of 15 per day
Respiratory, thoracic and mediastinal disorders Throat Irritation	4.0% 4/100 • Number of events 5 • From baseline to Week 14 All adverse events	13.0% 13/100 • Number of events 15 • From baseline to Week 14 All adverse events
Injury, poisoning and procedural complications Mouth Injury	5.0% 5/100 • Number of events 5 • From baseline to Week 14 All adverse events	6.0% 6/100 • Number of events 8 • From baseline to Week 14 All adverse events
Gastrointestinal disorders Oral Mucosal Erythema	1.0% 1/100 • Number of events 2 • From baseline to Week 14 All adverse events	3.0% 3/100 • Number of events 4 • From baseline to Week 14 All adverse events
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	1.0% 1/100 • Number of events 1 • From baseline to Week 14 All adverse events	5.0% 5/100 • Number of events 5 • From baseline to Week 14 All adverse events
Injury, poisoning and procedural complications Tooth Fracture	3.0% 3/100 • Number of events 3 • From baseline to Week 14 All adverse events	3.0% 3/100 • Number of events 3 • From baseline to Week 14 All adverse events
Gastrointestinal disorders Dry Mouth	2.0% 2/100 • Number of events 2 • From baseline to Week 14 All adverse events	3.0% 3/100 • Number of events 3 • From baseline to Week 14 All adverse events
Gastrointestinal disorders Gingival Ulceration	1.0% 1/100 • Number of events 1 • From baseline to Week 14 All adverse events	3.0% 3/100 • Number of events 4 • From baseline to Week 14 All adverse events
Gastrointestinal disorders Oral Discomfort	3.0% 3/100 • Number of events 3 • From baseline to Week 14 All adverse events	1.0% 1/100 • Number of events 1 • From baseline to Week 14 All adverse events
Gastrointestinal disorders Paraesthesia Oral	0.00% 0/100 • From baseline to Week 14 All adverse events	4.0% 4/100 • Number of events 4 • From baseline to Week 14 All adverse events
Gastrointestinal disorders Nausea	11.0% 11/100 • Number of events 12 • From baseline to Week 14 All adverse events	14.0% 14/100 • Number of events 17 • From baseline to Week 14 All adverse events
Gastrointestinal disorders Dyspepsia	6.0% 6/100 • Number of events 6 • From baseline to Week 14 All adverse events	8.0% 8/100 • Number of events 8 • From baseline to Week 14 All adverse events
Gastrointestinal disorders Flatulence	0.00% 0/100 • From baseline to Week 14 All adverse events	7.0% 7/100 • Number of events 7 • From baseline to Week 14 All adverse events
Gastrointestinal disorders Gastrointestinal Reflux Disease	3.0% 3/100 • Number of events 3 • From baseline to Week 14 All adverse events	0.00% 0/100 • From baseline to Week 14 All adverse events
Gastrointestinal disorders Vomitting	0.00% 0/100 • From baseline to Week 14 All adverse events	3.0% 3/100 • Number of events 3 • From baseline to Week 14 All adverse events
Infections and infestations Gastrooenteritis Viral	2.0% 2/100 • Number of events 2 • From baseline to Week 14 All adverse events	3.0% 3/100 • Number of events 3 • From baseline to Week 14 All adverse events
Infections and infestations Nasopharyngitis	17.0% 17/100 • Number of events 18 • From baseline to Week 14 All adverse events	19.0% 19/100 • Number of events 20 • From baseline to Week 14 All adverse events
Respiratory, thoracic and mediastinal disorders Hiccups	4.0% 4/100 • Number of events 4 • From baseline to Week 14 All adverse events	9.0% 9/100 • Number of events 12 • From baseline to Week 14 All adverse events
Respiratory, thoracic and mediastinal disorders Cough	2.0% 2/100 • Number of events 2 • From baseline to Week 14 All adverse events	5.0% 5/100 • Number of events 5 • From baseline to Week 14 All adverse events
Nervous system disorders Headache	9.0% 9/100 • Number of events 11 • From baseline to Week 14 All adverse events	4.0% 4/100 • Number of events 4 • From baseline to Week 14 All adverse events
Nervous system disorders Dizziness	3.0% 3/100 • Number of events 3 • From baseline to Week 14 All adverse events	1.0% 1/100 • Number of events 1 • From baseline to Week 14 All adverse events
Psychiatric disorders Insomnia	3.0% 3/100 • Number of events 3 • From baseline to Week 14 All adverse events	0.00% 0/100 • From baseline to Week 14 All adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER