Trial Outcomes & Findings for A Pilot Study Of Smoking Cessation Treatment Including Varenicline In Patients Scheduled For Planned Surgery (NCT NCT00889720)
NCT ID: NCT00889720
Last Updated: 2011-10-17
Results Overview
Compliance defined as completed 12 weeks of varenicline therapy, underwent surgery 8 weeks +-10 days after start of varenicline treatment, and had evaluations of wound infection 1 to 3 days and 6 to 10 days after surgery.
COMPLETED
PHASE4
16 participants
Baseline through Week 12
2011-10-17
Participant Flow
Participant milestones
| Measure |
Varenicline
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
Surgical Population
|
12
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Varenicline
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Other
|
4
|
Baseline Characteristics
A Pilot Study Of Smoking Cessation Treatment Including Varenicline In Patients Scheduled For Planned Surgery
Baseline characteristics by cohort
| Measure |
Varenicline
n=16 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
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|---|---|
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Age, Customized
Between 18 and 44 years
|
6 Participants
n=5 Participants
|
|
Age, Customized
Between 45 and 64 years
|
7 Participants
n=5 Participants
|
|
Age, Customized
>= 65 years
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3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 12Population: Surgical Population: subset of Full Analysis Set; includes all participants who took at least 1 dose (including partial doses) of study medication and received their planned surgery within the study period. N = participants in surgical population.
Compliance defined as completed 12 weeks of varenicline therapy, underwent surgery 8 weeks +-10 days after start of varenicline treatment, and had evaluations of wound infection 1 to 3 days and 6 to 10 days after surgery.
Outcome measures
| Measure |
Varenicline
n=12 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
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|---|---|
|
Percentage of Fully Compliant Participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Post-surgery Days 1-3Population: Surgical Population; N= number of participants with a Day 1-3 post-surgery visit.
Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.
Outcome measures
| Measure |
Varenicline
n=12 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
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|---|---|
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Number of Participants With Surgical Site Infection Post-surgery Days 1 to 3: Center for Disease Control (CDC) Definition
Category 0: no surgical wound complications
|
11 participants
|
|
Number of Participants With Surgical Site Infection Post-surgery Days 1 to 3: Center for Disease Control (CDC) Definition
Not done
|
1 participants
|
PRIMARY outcome
Timeframe: Post-surgery Days 6-10Population: Surgical Population; N= number of participants with a Day 6-10 post-surgery visit.
Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.
Outcome measures
| Measure |
Varenicline
n=12 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
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|---|---|
|
Number of Participants With Surgical Site Infection Post-surgery Days 6 to 10: Center for Disease Control (CDC) Definition
Category 0: no surgical wound complications
|
11 participants
|
|
Number of Participants With Surgical Site Infection Post-surgery Days 6 to 10: Center for Disease Control (CDC) Definition
Not Done
|
1 participants
|
PRIMARY outcome
Timeframe: Week 12Population: Surgical Population; N= number of participants with a Week 12 visit.
Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.
Outcome measures
| Measure |
Varenicline
n=11 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
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|---|---|
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Number of Participants With Surgical Site Infection at Week 12: Center for Disease Control (CDC) Definition
Category 0: no surgical wound complications
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9 participants
|
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Number of Participants With Surgical Site Infection at Week 12: Center for Disease Control (CDC) Definition
Not done
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2 participants
|
PRIMARY outcome
Timeframe: Week 26Population: Surgical Population; N= number of participants with a Week 26 visit.
Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.
Outcome measures
| Measure |
Varenicline
n=9 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
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|---|---|
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Number of Participants With Surgical Site Infection at Week 26: Center for Disease Control (CDC) Definition
Category 0: no surgical wound complications
|
9 participants
|
|
Number of Participants With Surgical Site Infection at Week 26: Center for Disease Control (CDC) Definition
Not done
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0 participants
|
PRIMARY outcome
Timeframe: Post-surgery Days 1-3, Post-surgery Days 6-10, Week 12, Week 26Population: Surgical Population; Due to satisfactory wound healing in all subjects, microbiological assessment was not necessary and no swabs were taken.
Microbiological confirmation defined as organisms isolated from an aseptically obtained culture of fluid or tissues from the superficial incision.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Post-surgery Days 1-3Population: Surgical Population; N= number of participants with a Day 1-3 post-surgery visit.
Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd \> 2 cm, c: large volume, D: prolonged \> 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd \> 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.
Outcome measures
| Measure |
Varenicline
n=12 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
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|---|---|
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Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 1 to 3: Southampton Wound Assessment Scale
Grade 0
|
10 participants
|
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Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 1 to 3: Southampton Wound Assessment Scale
Grade Ia
|
1 participants
|
|
Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 1 to 3: Southampton Wound Assessment Scale
Not done
|
1 participants
|
PRIMARY outcome
Timeframe: Post-surgery Days 6-10Population: Surgical Population; N= number of participants with a Day 6-10 post-surgery visit.
Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd \> 2 cm, c: large volume, D: prolonged \> 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd \> 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.
Outcome measures
| Measure |
Varenicline
n=12 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
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|---|---|
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Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 6 to 10: Southampton Wound Assessment Scale
Grade 0
|
8 participants
|
|
Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 6 to 10: Southampton Wound Assessment Scale
Grade Ia
|
1 participants
|
|
Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 6 to 10: Southampton Wound Assessment Scale
Grade IIa
|
1 participants
|
|
Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 6 to 10: Southampton Wound Assessment Scale
Grade IIb
|
1 participants
|
|
Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 6 to 10: Southampton Wound Assessment Scale
Not done
|
1 participants
|
PRIMARY outcome
Timeframe: Week 12Population: Surgical Population; N= number of participants with a Week 12 visit.
Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd \> 2 cm, c: large volume, D: prolonged \> 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd \> 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.
Outcome measures
| Measure |
Varenicline
n=11 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
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|---|---|
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Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 12: Southampton Wound Assessment Scale
Grade Ia
|
1 participants
|
|
Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 12: Southampton Wound Assessment Scale
Grade 0
|
8 participants
|
|
Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 12: Southampton Wound Assessment Scale
Not done
|
2 participants
|
PRIMARY outcome
Timeframe: Week 26Population: Surgical Population; N= number of participants with a Week 26 visit.
Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd \> 2 cm, c: large volume, D: prolonged \> 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd \> 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.
Outcome measures
| Measure |
Varenicline
n=9 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
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|---|---|
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Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 26: Southampton Wound Assessment Scale
Grade 0
|
8 participants
|
|
Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 26: Southampton Wound Assessment Scale
Not done
|
1 participants
|
PRIMARY outcome
Timeframe: Post-surgery Days 1-3Population: Surgical Population; N= number of participants who had ASEPSIS wound grading during the study and had a Day 1-3 post-surgery visit.
Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (\>40). Surgical site complication defined as total score \>10; wound infection defined as total score \>20. Not done = not assessed.
Outcome measures
| Measure |
Varenicline
n=8 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
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|---|---|
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Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 1 to 3
Satisfactory healing
|
7 participants
|
|
Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 1 to 3
Not done
|
1 participants
|
PRIMARY outcome
Timeframe: Post-surgery Days 6-10Population: Surgical Population; N= number of participants who had ASEPSIS wound grading during the study and had a Day 6-10 post-surgery visit.
Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (\>40). Surgical site complication defined as total score \>10; wound infection defined as total score \>20. Not done = not assessed.
Outcome measures
| Measure |
Varenicline
n=8 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
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|---|---|
|
Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 6 to 10
Satisfactory healing
|
7 participants
|
|
Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 6 to 10
Not done
|
1 participants
|
PRIMARY outcome
Timeframe: Week 12Population: Surgical Population; N = number of participants who had ASEPSIS wound grading during the study and had a Week 12 visit.
Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (\>40). Surgical site complication defined as total score \>10; wound infection defined as total score \>20. Not done = not assessed.
Outcome measures
| Measure |
Varenicline
n=7 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
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|---|---|
|
Wound Healing Grade by ASEPSIS Criteria at Week 12
Satisfactory healing
|
6 participants
|
|
Wound Healing Grade by ASEPSIS Criteria at Week 12
Not done
|
1 participants
|
PRIMARY outcome
Timeframe: Week 26Population: Surgical Population; N = number of participants who had ASEPSIS wound grading during the study and had a Week 24 visit.
Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (\>40). Surgical site complication defined as total score \>10; wound infection defined as total score \>20. Not done = not assessed.
Outcome measures
| Measure |
Varenicline
n=6 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
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|---|---|
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Wound Healing Grade by ASEPSIS Criteria at Week 26
Satisfactory healing
|
6 participants
|
|
Wound Healing Grade by ASEPSIS Criteria at Week 26
Not done
|
0 participants
|
PRIMARY outcome
Timeframe: 7 days prior to hospital admission to day of hospital admission (after Week 8 of treatment)Population: Surgical population: N = participants who took at least 1 dose of study medication and received planned surgery.
Responder defined as participant who answered "No" to question on Nicotine Use Inventory (NUI), "Has the subject smoked any cigarettes or cigarillos or used any other nicotine containing products in the last 7 days?" Additionally, responder status confirmed by measurement of end-expiratory exhaled carbon monoxide concentration \<10 parts per million (ppm).
Outcome measures
| Measure |
Varenicline
n=12 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
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|---|---|
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Number of Participants With 7 Day Point Prevalence (PP) for Smoking Abstinence Prior to Hospital Admission.
|
9 participants
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: Surgical Population; N = participants who took at least 1 dose of study medication and received planned surgery. Results provided for participants who had a study visit at timepoint. For participants with more than 1 incidence of surgical complication recorded, the most severe incidence was used for analysis. Abbreviations: PS=post-surgery.
Grade 0: no post-operative (post-op) complications (comp), Grade 1: any deviation from normal post-op course without need for pharmacological treatment (PT) other than allowed interventions (INT), or surgical, endoscopic or radiological INT; Grade II: required PT with drugs other than those allowed for grade I comp; Grade III required surgical, endoscopic or radiological INT, IIIa: not under general anaesthesia (GA), IIIb: under GA; Grade IV: life-threatening comp requiring IC/ICU management, IVa: single organ dysfunction (DSF), IVb: multiorgan DSF; Grade V: death. Not done = not assessed.
Outcome measures
| Measure |
Varenicline
n=12 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
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|---|---|
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Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System
Week 12: Not done
|
2 participants
|
|
Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System
1-3 days PS: No post-operative complications
|
10 participants
|
|
Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System
1-3 days PS: Grade II
|
1 participants
|
|
Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System
1-3 days PS: Not done
|
1 participants
|
|
Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System
6-10 days PS: No post-operative complications
|
7 participants
|
|
Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System
6-10 days PS: Grade I
|
3 participants
|
|
Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System
6-10 days PS: Grade II
|
1 participants
|
|
Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System
6-10 days PS: Not done
|
1 participants
|
|
Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System
Week 12: No post-operative complications
|
7 participants
|
|
Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System
Week 12: Grade II
|
1 participants
|
|
Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System
Week 12: Grade IIIb
|
1 participants
|
|
Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System
Week 26: No post-operative complications
|
8 participants
|
|
Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System
Week 26: Grade IIIb
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Surgical population. Not analyzed due the limited number of participants recruited.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: Surgical population: N = number of participants who had a Week 12 visit.
Responder defined as participant who answered "No" to question on Nicotine Use Inventory (NUI), "Has the subject smoked any cigarettes or cigarillos or used any other nicotine containing products in the last 7 days?" Additionally, responder status confirmed by measurement of end-expiratory exhaled carbon monoxide concentration \<10 parts per million (ppm).
Outcome measures
| Measure |
Varenicline
n=11 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
|
|---|---|
|
Number of Participants With 7-day Point Prevalence (PP) for Abstinence From Cigarette Smoking and Other Nicotine Use at the End of Treatment (Week 12)
|
9 participants
|
SECONDARY outcome
Timeframe: Week 26Population: Surgical population: N = number of participants who had a Week 26 visit.
Responder defined as participant who answered "No" to question on Nicotine Use Inventory (NUI), "Has the subject smoked any cigarettes or cigarillos or used any other nicotine containing products in the last 7 days?" Additionally, responder status confirmed by measurement of end-expiratory exhaled carbon monoxide concentration \<10 parts per million (ppm).
Outcome measures
| Measure |
Varenicline
n=9 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
|
|---|---|
|
Number of Participants With 7 Day Point Prevalence (PP) for Abstinence in the Week Preceding Week 26
|
7 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 26Population: Surgical population: Not analyzed due the limited number of participants recruited.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Week 26 (within 30 days of last dose)Population: Safety analysis set: participants who took at least 1 dose (including partial doses) of study medication. N = number of treated subjects. Includes data up to 30 days after last dose of study drug.
Treatment-emergent AE (TEAE): any untoward medical occurrence that occurred or worsened after beginning study treatment without regard to causal relationship. Treatment-related TEAE: investigator assessment of reasonable possibility that treatment caused or contributed to AE. Severe TEAE: interfered significantly with usual function. SAE: AE resulting in death, initial or prolonged inpatient hospitalization, a life-threatening experience (immediate risk of death), persistent or significant disability/incapacity, congenital anomaly, or deemed significant for any other reason.
Outcome measures
| Measure |
Varenicline
n=16 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline
SAE: treatment-related
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline
Severe TEAE: all causalities
|
3 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline
Severe TEAE: treatment-related
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline
SAE: all causalities
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline
TEAE: all causalities
|
9 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline
TEAE: treatment-related
|
8 participants
|
SECONDARY outcome
Timeframe: Baseline through Week 26 (within 30 days of last dose)Population: Safety analysis set. N = number of treated subjects. Includes data up to 30 days after last dose of study drug.
Mild: did not interfere with usual function; Moderate: interfered to some extent with usual function; Severe: interfered significantly with usual function. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the most severe occurrence was taken. Missing baseline severities were imputed as mild.
Outcome measures
| Measure |
Varenicline
n=16 Participants
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
|
|---|---|
|
Number of Treatment Emergent Adverse Events by Severity
Mild
|
13 events
|
|
Number of Treatment Emergent Adverse Events by Severity
Moderate
|
11 events
|
|
Number of Treatment Emergent Adverse Events by Severity
Severe
|
4 events
|
Adverse Events
Varenicline
Serious adverse events
| Measure |
Varenicline
n=16 participants at risk
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
|
|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Varenicline
n=16 participants at risk
Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
|
|---|---|
|
Cardiac disorders
Tachycardia
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
18.8%
3/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Asthenia
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Feeling abnormal
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral rhinitis
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Transaminases increased
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
2/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Abnormal dreams
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Decreased interest
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
18.8%
3/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Libido decreased
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Mental disorder
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Lymphoedema
|
6.2%
1/16
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 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