Trial Outcomes & Findings for Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment (NCT NCT00749463)
NCT ID: NCT00749463
Last Updated: 2012-07-13
Results Overview
Percentage of subjects with treatment-related adverse events by preferred term, included if the percentage in any single arm was 1% or higher
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
300 participants
Primary outcome timeframe
24 Weeks
Results posted on
2012-07-13
Participant Flow
Participant milestones
| Measure |
Nicotine Gum 2
Dosage: 2 mg, Dosage Form: Gum
|
Nicotine Gum 4
Dosage: 4 mg, Dosage Form: Gum
|
Nicotine Patch
Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
|
|---|---|---|---|
|
Overall Study
STARTED
|
86
|
64
|
150
|
|
Overall Study
COMPLETED
|
85
|
60
|
149
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
1
|
Reasons for withdrawal
| Measure |
Nicotine Gum 2
Dosage: 2 mg, Dosage Form: Gum
|
Nicotine Gum 4
Dosage: 4 mg, Dosage Form: Gum
|
Nicotine Patch
Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment
Baseline characteristics by cohort
| Measure |
Nicotine Gum 2
n=86 Participants
Dosage: 2 mg, Dosage Form: Gum
|
Nicotine Gum 4
n=64 Participants
Dosage: 4 mg, Dosage Form: Gum
|
Nicotine Patch
n=150 Participants
Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
40.6 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
40.3 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
41.7 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
297 Participants
n=4 Participants
|
|
Region of Enrollment
China
|
86 participants
n=5 Participants
|
64 participants
n=7 Participants
|
150 participants
n=5 Participants
|
300 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: Safety Analysis Set (ITT)
Percentage of subjects with treatment-related adverse events by preferred term, included if the percentage in any single arm was 1% or higher
Outcome measures
| Measure |
Nicotine Gum 2
n=86 Participants
Dosage: 2 mg, Dosage Form: Gum
|
Nicotine Gum 4
n=64 Participants
Dosage: 4 mg, Dosage Form: Gum
|
Nicotine Patch
n=150 Participants
Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
|
|---|---|---|---|
|
Treatment-Related Adverse Events
Subjects with at Least One Treatment-Related AE
|
25.6 Percentage of Participants
|
39.1 Percentage of Participants
|
21.3 Percentage of Participants
|
|
Treatment-Related Adverse Events
Sinus tachycardia
|
0 Percentage of Participants
|
1.6 Percentage of Participants
|
0 Percentage of Participants
|
|
Treatment-Related Adverse Events
Abdominal distension
|
2.3 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Treatment-Related Adverse Events
Abdominal pain upper
|
3.5 Percentage of Participants
|
1.6 Percentage of Participants
|
0.6 Percentage of Participants
|
|
Treatment-Related Adverse Events
Abdominal symptom
|
1.2 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Treatment-Related Adverse Events
Diarrhoea
|
0 Percentage of Participants
|
1.6 Percentage of Participants
|
0.6 Percentage of Participants
|
|
Treatment-Related Adverse Events
Dyspepsia
|
1.2 Percentage of Participants
|
1.6 Percentage of Participants
|
0 Percentage of Participants
|
|
Treatment-Related Adverse Events
Eructation
|
0 Percentage of Participants
|
1.6 Percentage of Participants
|
0 Percentage of Participants
|
|
Treatment-Related Adverse Events
Gingival ulceration
|
0 Percentage of Participants
|
1.6 Percentage of Participants
|
0 Percentage of Participants
|
|
Treatment-Related Adverse Events
Mouth ulceration
|
2.3 Percentage of Participants
|
0 Percentage of Participants
|
0.6 Percentage of Participants
|
|
Treatment-Related Adverse Events
Nausea
|
15.1 Percentage of Participants
|
21.9 Percentage of Participants
|
5.3 Percentage of Participants
|
|
Treatment-Related Adverse Events
Oral discomfort
|
1.2 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Treatment-Related Adverse Events
Retching
|
0 Percentage of Participants
|
1.6 Percentage of Participants
|
0 Percentage of Participants
|
|
Treatment-Related Adverse Events
Chest discomfort
|
1.2 Percentage of Participants
|
3.1 Percentage of Participants
|
0 Percentage of Participants
|
|
Treatment-Related Adverse Events
Heart rate increased
|
0 Percentage of Participants
|
1.6 Percentage of Participants
|
0 Percentage of Participants
|
|
Treatment-Related Adverse Events
Myalgia
|
0 Percentage of Participants
|
1.6 Percentage of Participants
|
0 Percentage of Participants
|
|
Treatment-Related Adverse Events
Dizziness
|
1.2 Percentage of Participants
|
1.6 Percentage of Participants
|
2.0 Percentage of Participants
|
|
Treatment-Related Adverse Events
Insomnia
|
0 Percentage of Participants
|
0 Percentage of Participants
|
1.3 Percentage of Participants
|
|
Treatment-Related Adverse Events
Hiccups
|
0 Percentage of Participants
|
1.6 Percentage of Participants
|
0 Percentage of Participants
|
|
Treatment-Related Adverse Events
Oropharyngeal pain
|
8.1 Percentage of Participants
|
7.8 Percentage of Participants
|
0.6 Percentage of Participants
|
|
Treatment-Related Adverse Events
Tachypnoea
|
1.2 Percentage of Participants
|
1.6 Percentage of Participants
|
0 Percentage of Participants
|
|
Treatment-Related Adverse Events
Dermatitis allergic
|
0 Percentage of Participants
|
0 Percentage of Participants
|
8.0 Percentage of Participants
|
|
Treatment-Related Adverse Events
Pruritus
|
0 Percentage of Participants
|
0 Percentage of Participants
|
2.0 Percentage of Participants
|
|
Treatment-Related Adverse Events
Rash vesicular
|
0 Percentage of Participants
|
0 Percentage of Participants
|
1.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: 24 WeeksPercentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day
Outcome measures
| Measure |
Nicotine Gum 2
n=86 Participants
Dosage: 2 mg, Dosage Form: Gum
|
Nicotine Gum 4
n=64 Participants
Dosage: 4 mg, Dosage Form: Gum
|
Nicotine Patch
n=150 Participants
Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
|
|---|---|---|---|
|
Self-Reported Smoking Reduction
Week 1
|
78.8 Percentage of Participants
Standard Deviation 24.3
|
73.6 Percentage of Participants
Standard Deviation 21.9
|
75.2 Percentage of Participants
Standard Deviation 25.1
|
|
Self-Reported Smoking Reduction
Week 2
|
79.9 Percentage of Participants
Standard Deviation 22.0
|
73.5 Percentage of Participants
Standard Deviation 21.6
|
77.0 Percentage of Participants
Standard Deviation 24.4
|
|
Self-Reported Smoking Reduction
Week 3
|
81.0 Percentage of Participants
Standard Deviation 22.6
|
77.3 Percentage of Participants
Standard Deviation 22.2
|
79.9 Percentage of Participants
Standard Deviation 23.7
|
|
Self-Reported Smoking Reduction
Week 4
|
84.2 Percentage of Participants
Standard Deviation 20.1
|
78.6 Percentage of Participants
Standard Deviation 23.6
|
80.3 Percentage of Participants
Standard Deviation 24.2
|
|
Self-Reported Smoking Reduction
Week 6
|
81.0 Percentage of Participants
Standard Deviation 23.6
|
78.0 Percentage of Participants
Standard Deviation 22.8
|
77.2 Percentage of Participants
Standard Deviation 26.7
|
|
Self-Reported Smoking Reduction
Week 8
|
80.8 Percentage of Participants
Standard Deviation 23.5
|
75.4 Percentage of Participants
Standard Deviation 24.6
|
77.1 Percentage of Participants
Standard Deviation 28.9
|
|
Self-Reported Smoking Reduction
Week 10
|
80.9 Percentage of Participants
Standard Deviation 24.5
|
76.0 Percentage of Participants
Standard Deviation 24.0
|
77.6 Percentage of Participants
Standard Deviation 27.7
|
|
Self-Reported Smoking Reduction
Week 12
|
80.8 Percentage of Participants
Standard Deviation 24.1
|
77.0 Percentage of Participants
Standard Deviation 22.0
|
78.7 Percentage of Participants
Standard Deviation 27.5
|
|
Self-Reported Smoking Reduction
Week 16
|
76.0 Percentage of Participants
Standard Deviation 27.1
|
72.3 Percentage of Participants
Standard Deviation 26.3
|
74.8 Percentage of Participants
Standard Deviation 31.6
|
|
Self-Reported Smoking Reduction
Week 20
|
73.7 Percentage of Participants
Standard Deviation 29.7
|
69.3 Percentage of Participants
Standard Deviation 28.5
|
74.0 Percentage of Participants
Standard Deviation 32.6
|
|
Self-Reported Smoking Reduction
Week 24
|
72.7 Percentage of Participants
Standard Deviation 31.6
|
63.7 Percentage of Participants
Standard Deviation 31.0
|
71.9 Percentage of Participants
Standard Deviation 34.0
|
PRIMARY outcome
Timeframe: 24 WeeksContinuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day
Outcome measures
| Measure |
Nicotine Gum 2
n=86 Participants
Dosage: 2 mg, Dosage Form: Gum
|
Nicotine Gum 4
n=64 Participants
Dosage: 4 mg, Dosage Form: Gum
|
Nicotine Patch
n=150 Participants
Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
|
|---|---|---|---|
|
Smoking Abstinence
Visit at 2 Weeks
|
24 Participants
|
9 Participants
|
34 Participants
|
|
Smoking Abstinence
Visit at 6 Weeks
|
19 Participants
|
7 Participants
|
24 Participants
|
|
Smoking Abstinence
Visit at 8 Weeks
|
18 Participants
|
7 Participants
|
24 Participants
|
|
Smoking Abstinence
Visit at 10 Weeks
|
17 Participants
|
7 Participants
|
22 Participants
|
|
Smoking Abstinence
Visit at 12 Weeks
|
16 Participants
|
7 Participants
|
21 Participants
|
|
Smoking Abstinence
Visit at 24 Weeks
|
13 Participants
|
7 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Percentage of participants with carbon monoxide (CO)-verified reduction from baseline in number of cigarettes smoked per day (%)
Outcome measures
| Measure |
Nicotine Gum 2
n=86 Participants
Dosage: 2 mg, Dosage Form: Gum
|
Nicotine Gum 4
n=64 Participants
Dosage: 4 mg, Dosage Form: Gum
|
Nicotine Patch
n=150 Participants
Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
|
|---|---|---|---|
|
Carbon Monoxide (CO)-Verified Smoking Reduction
Visit at 2 Weeks
|
82.3 Percentage of Participants
Standard Deviation 21.1
|
76.1 Percentage of Participants
Standard Deviation 20.0
|
80.6 Percentage of Participants
Standard Deviation 19.0
|
|
Carbon Monoxide (CO)-Verified Smoking Reduction
Visit at 6 Weeks
|
83.7 Percentage of Participants
Standard Deviation 20.4
|
78.9 Percentage of Participants
Standard Deviation 22.4
|
81.6 Percentage of Participants
Standard Deviation 21.0
|
|
Carbon Monoxide (CO)-Verified Smoking Reduction
Visit at 8 Weeks
|
86.1 Percentage of Participants
Standard Deviation 18.0
|
77.4 Percentage of Participants
Standard Deviation 23.4
|
81.9 Percentage of Participants
Standard Deviation 23.3
|
|
Carbon Monoxide (CO)-Verified Smoking Reduction
Visit at 10 Weeks
|
85.1 Percentage of Participants
Standard Deviation 18.9
|
78.7 Percentage of Participants
Standard Deviation 20.0
|
82.9 Percentage of Participants
Standard Deviation 22.2
|
|
Carbon Monoxide (CO)-Verified Smoking Reduction
Visit at 12 Weeks
|
84.7 Percentage of Participants
Standard Deviation 19.4
|
79.5 Percentage of Participants
Standard Deviation 19.8
|
83.4 Percentage of Participants
Standard Deviation 23.6
|
|
Carbon Monoxide (CO)-Verified Smoking Reduction
Visit at 24 Weeks
|
80.4 Percentage of Participants
Standard Deviation 25.5
|
67.6 Percentage of Participants
Standard Deviation 29.2
|
81.2 Percentage of Participants
Standard Deviation 25.5
|
SECONDARY outcome
Timeframe: 24 Weeks from last visit:Number of cigarettes smoked by subjects reporting smoking since last visit - total during the day (for daily smokers)
Outcome measures
| Measure |
Nicotine Gum 2
n=35 Participants
Dosage: 2 mg, Dosage Form: Gum
|
Nicotine Gum 4
n=37 Participants
Dosage: 4 mg, Dosage Form: Gum
|
Nicotine Patch
n=67 Participants
Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
|
|---|---|---|---|
|
Smoking Consumption Per Day
|
9.5 Cigarettes
Standard Deviation 6.3
|
16.1 Cigarettes
Standard Deviation 8.2
|
11.9 Cigarettes
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: 24 Weeks from last visit:Number of cigarettes smoked by subjects reporting smoking since last visit - total during the the week (for non-daily smokers)
Outcome measures
| Measure |
Nicotine Gum 2
n=18 Participants
Dosage: 2 mg, Dosage Form: Gum
|
Nicotine Gum 4
n=7 Participants
Dosage: 4 mg, Dosage Form: Gum
|
Nicotine Patch
n=25 Participants
Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
|
|---|---|---|---|
|
Smoking Consumption Per Week
|
25.8 Cigarettes
Standard Deviation 21.4
|
41.6 Cigarettes
Standard Deviation 27.7
|
22.1 Cigarettes
Standard Deviation 24.6
|
SECONDARY outcome
Timeframe: 24 WeeksPoint Prevalence Smoking Abstinence since last visit. Point prevalence abstinence is defined as the percentage of former smokers who are not smoking at a particular point in time, typically at the time of assessment.
Outcome measures
| Measure |
Nicotine Gum 2
n=86 Participants
Dosage: 2 mg, Dosage Form: Gum
|
Nicotine Gum 4
n=64 Participants
Dosage: 4 mg, Dosage Form: Gum
|
Nicotine Patch
n=150 Participants
Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
|
|---|---|---|---|
|
Point Prevalence Smoking Abstinence (PPSA)
Week 1
|
28 Participants
|
11 Participants
|
42 Participants
|
|
Point Prevalence Smoking Abstinence (PPSA)
Week 2
|
28 Participants
|
13 Participants
|
43 Participants
|
|
Point Prevalence Smoking Abstinence (PPSA)
Week 3
|
33 Participants
|
15 Participants
|
50 Participants
|
|
Point Prevalence Smoking Abstinence (PPSA)
Week 4
|
33 Participants
|
16 Participants
|
55 Participants
|
|
Point Prevalence Smoking Abstinence (PPSA)
Week 6
|
31 Participants
|
16 Participants
|
45 Participants
|
|
Point Prevalence Smoking Abstinence (PPSA)
Week 8
|
33 Participants
|
16 Participants
|
50 Participants
|
|
Point Prevalence Smoking Abstinence (PPSA)
Week 10
|
32 Participants
|
16 Participants
|
51 Participants
|
|
Point Prevalence Smoking Abstinence (PPSA)
Week 12
|
34 Participants
|
16 Participants
|
60 Participants
|
|
Point Prevalence Smoking Abstinence (PPSA)
Week 16
|
33 Participants
|
17 Participants
|
53 Participants
|
|
Point Prevalence Smoking Abstinence (PPSA)
Week 20
|
32 Participants
|
17 Participants
|
55 Participants
|
|
Point Prevalence Smoking Abstinence (PPSA)
Week 24
|
32 Participants
|
16 Participants
|
57 Participants
|
Adverse Events
Nicotine Gum 2
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Nicotine Gum 4
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Nicotine Patch
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nicotine Gum 2
n=86 participants at risk
Dosage: 2 mg, Dosage Form: Gum
|
Nicotine Gum 4
n=64 participants at risk
Dosage: 4 mg, Dosage Form: Gum
|
Nicotine Patch
n=150 participants at risk
Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
|
|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/86 • 24 Weeks
|
1.6%
1/64 • 24 Weeks
|
0.00%
0/150 • 24 Weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
2.3%
2/86 • 24 Weeks
|
0.00%
0/64 • 24 Weeks
|
0.00%
0/150 • 24 Weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.5%
3/86 • 24 Weeks
|
1.6%
1/64 • 24 Weeks
|
0.67%
1/150 • 24 Weeks
|
|
Gastrointestinal disorders
Abdominal symptom
|
1.2%
1/86 • 24 Weeks
|
0.00%
0/64 • 24 Weeks
|
0.00%
0/150 • 24 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/86 • 24 Weeks
|
1.6%
1/64 • 24 Weeks
|
0.67%
1/150 • 24 Weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
1.2%
1/86 • 24 Weeks
|
1.6%
1/64 • 24 Weeks
|
0.00%
0/150 • 24 Weeks
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/86 • 24 Weeks
|
1.6%
1/64 • 24 Weeks
|
0.00%
0/150 • 24 Weeks
|
|
Gastrointestinal disorders
Gingival ulceration
|
0.00%
0/86 • 24 Weeks
|
1.6%
1/64 • 24 Weeks
|
0.00%
0/150 • 24 Weeks
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.3%
2/86 • 24 Weeks
|
0.00%
0/64 • 24 Weeks
|
0.67%
1/150 • 24 Weeks
|
|
Gastrointestinal disorders
Nausea
|
15.1%
13/86 • 24 Weeks
|
23.4%
15/64 • 24 Weeks
|
5.3%
8/150 • 24 Weeks
|
|
Gastrointestinal disorders
Oral discomfort
|
1.2%
1/86 • 24 Weeks
|
0.00%
0/64 • 24 Weeks
|
0.00%
0/150 • 24 Weeks
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/86 • 24 Weeks
|
1.6%
1/64 • 24 Weeks
|
0.00%
0/150 • 24 Weeks
|
|
General disorders
Chest discomfort
|
1.2%
1/86 • 24 Weeks
|
3.1%
2/64 • 24 Weeks
|
0.00%
0/150 • 24 Weeks
|
|
Investigations
Heart rate increased
|
0.00%
0/86 • 24 Weeks
|
1.6%
1/64 • 24 Weeks
|
0.00%
0/150 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/86 • 24 Weeks
|
1.6%
1/64 • 24 Weeks
|
0.00%
0/150 • 24 Weeks
|
|
Nervous system disorders
Dizziness
|
1.2%
1/86 • 24 Weeks
|
1.6%
1/64 • 24 Weeks
|
2.0%
3/150 • 24 Weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/86 • 24 Weeks
|
0.00%
0/64 • 24 Weeks
|
1.3%
2/150 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/86 • 24 Weeks
|
1.6%
1/64 • 24 Weeks
|
0.00%
0/150 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.1%
7/86 • 24 Weeks
|
7.8%
5/64 • 24 Weeks
|
0.67%
1/150 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
1.2%
1/86 • 24 Weeks
|
1.6%
1/64 • 24 Weeks
|
0.00%
0/150 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/86 • 24 Weeks
|
0.00%
0/64 • 24 Weeks
|
8.0%
12/150 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/86 • 24 Weeks
|
0.00%
0/64 • 24 Weeks
|
2.0%
3/150 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/86 • 24 Weeks
|
0.00%
0/64 • 24 Weeks
|
1.3%
2/150 • 24 Weeks
|
Additional Information
Joyce Hauze, Sr Specialist, Clinical Research Operations
J&J Consumer and Personal Products Worldwide
Phone: 928-277-0715
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60