Trial Outcomes & Findings for Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking (NCT NCT00594204)
NCT ID: NCT00594204
Last Updated: 2010-07-20
Results Overview
The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) \> 10 parts per milion (ppm) at any of these visits
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
593 participants
Primary outcome timeframe
Weeks 9 through 12
Results posted on
2010-07-20
Participant Flow
Participant milestones
| Measure |
Varenicline
0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
|
Placebo
matching placebo following the same treatment schema as the varenicline group
|
|---|---|---|
|
Overall Study
STARTED
|
394
|
199
|
|
Overall Study
Received Treatment
|
390
|
198
|
|
Overall Study
COMPLETED
|
336
|
154
|
|
Overall Study
NOT COMPLETED
|
58
|
45
|
Reasons for withdrawal
| Measure |
Varenicline
0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
|
Placebo
matching placebo following the same treatment schema as the varenicline group
|
|---|---|---|
|
Overall Study
Adverse Event
|
15
|
3
|
|
Overall Study
Lost to Follow-up
|
9
|
5
|
|
Overall Study
Withdrawal by Subject
|
23
|
29
|
|
Overall Study
Other
|
4
|
3
|
|
Overall Study
Lack of Efficacy
|
3
|
4
|
|
Overall Study
Randomized but not treated
|
4
|
1
|
Baseline Characteristics
Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking
Baseline characteristics by cohort
| Measure |
Varenicline
n=390 Participants
0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
|
Placebo
n=198 Participants
matching placebo following the same treatment schema as the varenicline group
|
Total
n=588 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 55
|
334 years
n=5 Participants
|
164 years
n=7 Participants
|
498 years
n=5 Participants
|
|
Age, Customized
55 - 65
|
49 years
n=5 Participants
|
28 years
n=7 Participants
|
77 years
n=5 Participants
|
|
Age, Customized
> 65
|
7 years
n=5 Participants
|
6 years
n=7 Participants
|
13 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
165 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
225 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
355 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 9 through 12Population: Intent-to-treat (ITT)
The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) \> 10 parts per milion (ppm) at any of these visits
Outcome measures
| Measure |
Varenicline
n=390 Participants
0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
|
Placebo
n=198 Participants
matching placebo following the same treatment schema as the varenicline group
|
|---|---|---|
|
Number of Participants With 4-week Continuous Abstinence
|
209 participants
|
37 participants
|
SECONDARY outcome
Timeframe: Weeks 9 through 24Population: ITT
The number of participants who, at each contact from Week 9 through the given timepoint, reported no smoking and no use of other nicotine-containing products (Treatment Phase) or tobacco products (Nontreatment Phase) since the last study contact(on the Nicotine Use Inventory) and who did not have CO \> 10 ppm
Outcome measures
| Measure |
Varenicline
n=390 Participants
0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
|
Placebo
n=198 Participants
matching placebo following the same treatment schema as the varenicline group
|
|---|---|---|
|
Number of Participants With Continuous Abstinence
|
155 participants
|
26 participants
|
SECONDARY outcome
Timeframe: Week 12 and 24Population: ITT
Number of participants who, at the given visit or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and who did not have CO \>10 ppm on that day
Outcome measures
| Measure |
Varenicline
n=390 Participants
0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
|
Placebo
n=198 Participants
matching placebo following the same treatment schema as the varenicline group
|
|---|---|---|
|
Number of Participants With Seven-day Point Prevalence of Abstinence
Week 12
|
220 participants
|
45 participants
|
|
Number of Participants With Seven-day Point Prevalence of Abstinence
Week 24
|
185 participants
|
38 participants
|
Adverse Events
Varenicline
Serious events: 11 serious events
Other events: 224 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline
n=390 participants at risk
0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
|
Placebo
n=198 participants at risk
matching placebo following the same treatment schema as the varenicline group
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.26%
1/390
|
0.00%
0/198
|
|
Cardiac disorders
Palpitations
|
0.26%
1/390
|
0.00%
0/198
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/390
|
0.51%
1/198
|
|
Immune system disorders
Hypersensitivity
|
0.26%
1/390
|
0.00%
0/198
|
|
Infections and infestations
Appendicitis
|
0.00%
0/390
|
0.51%
1/198
|
|
Infections and infestations
Bronchitis
|
0.26%
1/390
|
0.00%
0/198
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/390
|
0.51%
1/198
|
|
Injury, poisoning and procedural complications
Laceration
|
0.26%
1/390
|
0.00%
0/198
|
|
Injury, poisoning and procedural complications
Overdose
|
0.26%
1/390
|
0.00%
0/198
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/390
|
0.51%
1/198
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.26%
1/390
|
0.00%
0/198
|
|
Psychiatric disorders
Depressed mood
|
0.26%
1/390
|
0.00%
0/198
|
|
Psychiatric disorders
Panic attack
|
0.26%
1/390
|
0.00%
0/198
|
|
Psychiatric disorders
Suicidal ideation
|
0.51%
2/390
|
0.00%
0/198
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.26%
1/390
|
0.00%
0/198
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.26%
1/390
|
0.00%
0/198
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.26%
1/390
|
0.00%
0/198
|
|
Surgical and medical procedures
Appendicectomy
|
0.26%
1/390
|
0.00%
0/198
|
Other adverse events
| Measure |
Varenicline
n=390 participants at risk
0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
|
Placebo
n=198 participants at risk
matching placebo following the same treatment schema as the varenicline group
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
9/390
|
0.51%
1/198
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.1%
16/390
|
2.5%
5/198
|
|
Gastrointestinal disorders
Constipation
|
5.9%
23/390
|
5.1%
10/198
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
9/390
|
1.0%
2/198
|
|
Gastrointestinal disorders
Dry mouth
|
3.6%
14/390
|
4.0%
8/198
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
13/390
|
3.0%
6/198
|
|
Gastrointestinal disorders
Flatulence
|
1.8%
7/390
|
2.5%
5/198
|
|
Gastrointestinal disorders
Nausea
|
26.4%
103/390
|
8.1%
16/198
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
12/390
|
0.51%
1/198
|
|
General disorders
Fatigue
|
2.3%
9/390
|
2.0%
4/198
|
|
General disorders
Irritability
|
4.4%
17/390
|
4.0%
8/198
|
|
General disorders
Malaise
|
2.6%
10/390
|
0.51%
1/198
|
|
Infections and infestations
Bronchitis
|
2.3%
9/390
|
2.0%
4/198
|
|
Infections and infestations
Influenza
|
3.6%
14/390
|
6.1%
12/198
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
13/390
|
2.0%
4/198
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
14/390
|
2.5%
5/198
|
|
Metabolism and nutrition disorders
Increased appetite
|
2.3%
9/390
|
0.51%
1/198
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
5/390
|
2.0%
4/198
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.51%
2/390
|
2.0%
4/198
|
|
Nervous system disorders
Dizziness
|
3.3%
13/390
|
4.5%
9/198
|
|
Nervous system disorders
Headache
|
16.4%
64/390
|
12.1%
24/198
|
|
Nervous system disorders
Somnolence
|
4.1%
16/390
|
4.5%
9/198
|
|
Psychiatric disorders
Abnormal dreams
|
2.1%
8/390
|
0.00%
0/198
|
|
Psychiatric disorders
Anxiety
|
4.1%
16/390
|
7.6%
15/198
|
|
Psychiatric disorders
Depression
|
2.1%
8/390
|
2.0%
4/198
|
|
Psychiatric disorders
Drug dependence
|
0.77%
3/390
|
2.5%
5/198
|
|
Psychiatric disorders
Insomnia
|
12.8%
50/390
|
6.6%
13/198
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
10/390
|
4.5%
9/198
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER