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A Pilot Study Of Smoking Cessation Treatment Including Varenicline In Patients Scheduled For Planned Surgery

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ClinicalTrials.gov Identifier: NCT00889720
Recruitment Status : Completed
First Posted : April 29, 2009
Results First Posted : August 25, 2011
Last Update Posted : October 17, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Smoking Cessation
Intervention Drug: Varenicline
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Varenicline
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 16
Surgical Population 12
Completed 8
Not Completed 8
Reason Not Completed
Withdrawal by Subject             4
Other             4
Arm/Group Title Varenicline
Hide Arm/Group Description 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 Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants
Between 18 and 44 years 6
Between 45 and 64 years 7
>= 65 years 3
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
7
  43.8%
Male
9
  56.3%
1.Primary Outcome
Title Percentage of Fully Compliant Participants
Hide Description 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.
Time Frame Baseline through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of participants
0
2.Primary Outcome
Title Number of Participants With Surgical Site Infection Post-surgery Days 1 to 3: Center for Disease Control (CDC) Definition
Hide Description 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.
Time Frame Post-surgery Days 1-3
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical Population; N= number of participants with a Day 1-3 post-surgery visit.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
Category 0: no surgical wound complications 11
Not done 1
3.Primary Outcome
Title Number of Participants With Surgical Site Infection Post-surgery Days 6 to 10: Center for Disease Control (CDC) Definition
Hide Description 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.
Time Frame Post-surgery Days 6-10
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical Population; N= number of participants with a Day 6-10 post-surgery visit.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
Category 0: no surgical wound complications 11
Not Done 1
4.Primary Outcome
Title Number of Participants With Surgical Site Infection at Week 12: Center for Disease Control (CDC) Definition
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical Population; N= number of participants with a Week 12 visit.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
Category 0: no surgical wound complications 9
Not done 2
5.Primary Outcome
Title Number of Participants With Surgical Site Infection at Week 26: Center for Disease Control (CDC) Definition
Hide Description 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.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical Population; N= number of participants with a Week 26 visit.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
Category 0: no surgical wound complications 9
Not done 0
6.Primary Outcome
Title Number of Participants With Surgical Site Infections With Microbiological Confirmation of Bacterial Infection
Hide Description Microbiological confirmation defined as organisms isolated from an aseptically obtained culture of fluid or tissues from the superficial incision.
Time Frame Post-surgery Days 1-3, Post-surgery Days 6-10, Week 12, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical Population; Due to satisfactory wound healing in all subjects, microbiological assessment was not necessary and no swabs were taken.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Primary Outcome
Title Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 1 to 3: Southampton Wound Assessment Scale
Hide Description 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.
Time Frame Post-surgery Days 1-3
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical Population; N= number of participants with a Day 1-3 post-surgery visit.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
Grade 0 10
Grade Ia 1
Not done 1
8.Primary Outcome
Title Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 6 to 10: Southampton Wound Assessment Scale
Hide Description 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.
Time Frame Post-surgery Days 6-10
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical Population; N= number of participants with a Day 6-10 post-surgery visit.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
Grade 0 8
Grade Ia 1
Grade IIa 1
Grade IIb 1
Not done 1
9.Primary Outcome
Title Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 12: Southampton Wound Assessment Scale
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical Population; N= number of participants with a Week 12 visit.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
Grade 0 8
Grade Ia 1
Not done 2
10.Primary Outcome
Title Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 26: Southampton Wound Assessment Scale
Hide Description 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.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical Population; N= number of participants with a Week 26 visit.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
Grade 0 8
Not done 1
11.Primary Outcome
Title Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 1 to 3
Hide Description 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.
Time Frame Post-surgery Days 1-3
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical Population; N= number of participants who had ASEPSIS wound grading during the study and had a Day 1-3 post-surgery visit.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
Satisfactory healing 7
Not done 1
12.Primary Outcome
Title Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 6 to 10
Hide Description 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.
Time Frame Post-surgery Days 6-10
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical Population; N= number of participants who had ASEPSIS wound grading during the study and had a Day 6-10 post-surgery visit.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
Satisfactory healing 7
Not done 1
13.Primary Outcome
Title Wound Healing Grade by ASEPSIS Criteria at Week 12
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical Population; N = number of participants who had ASEPSIS wound grading during the study and had a Week 12 visit.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
Satisfactory healing 6
Not done 1
14.Primary Outcome
Title Wound Healing Grade by ASEPSIS Criteria at Week 26
Hide Description 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.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical Population; N = number of participants who had ASEPSIS wound grading during the study and had a Week 24 visit.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Satisfactory healing 6
Not done 0
15.Primary Outcome
Title Number of Participants With 7 Day Point Prevalence (PP) for Smoking Abstinence Prior to Hospital Admission.
Hide Description 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).
Time Frame 7 days prior to hospital admission to day of hospital admission (after Week 8 of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical population: N = participants who took at least 1 dose of study medication and received planned surgery.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
9
16.Secondary Outcome
Title Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System
Hide Description 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.
Time Frame Baseline through Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
1-3 days PS: No post-operative complications 10
1-3 days PS: Grade II 1
1-3 days PS: Not done 1
6-10 days PS: No post-operative complications 7
6-10 days PS: Grade I 3
6-10 days PS: Grade II 1
6-10 days PS: Not done 1
Week 12: No post-operative complications 7
Week 12: Grade II 1
Week 12: Grade IIIb 1
Week 12: Not done 2
Week 26: No post-operative complications 8
Week 26: Grade IIIb 1
17.Secondary Outcome
Title Percentage of Participants Who Succeed in Reducing Their Cigarette Consumption by at Least 50% in 7 Days Preceding Hospital Admission Compared With Baseline.
Hide Description [Not Specified]
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical population. Not analyzed due the limited number of participants recruited.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title 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)
Hide Description 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).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical population: N = number of participants who had a Week 12 visit.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
9
19.Secondary Outcome
Title Number of Participants With 7 Day Point Prevalence (PP) for Abstinence in the Week Preceding Week 26
Hide Description 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).
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical population: N = number of participants who had a Week 26 visit.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
7
20.Secondary Outcome
Title Percentage of Participants Who Reduced Their Cigarette Consumption by at Least 50% in the 7 Days Preceding Weeks 12 and 26 Compared With Baseline.
Hide Description [Not Specified]
Time Frame Baseline, Week 12, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical population: Not analyzed due the limited number of participants recruited.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
21.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline
Hide Description 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.
Time Frame Baseline through Week 26 (within 30 days of last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
TEAE: all causalities 9
TEAE: treatment-related 8
Severe TEAE: all causalities 3
Severe TEAE: treatment-related 1
SAE: all causalities 1
SAE: treatment-related 0
22.Secondary Outcome
Title Number of Treatment Emergent Adverse Events by Severity
Hide Description 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.
Time Frame Baseline through Week 26 (within 30 days of last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set. N = number of treated subjects. Includes data up to 30 days after last dose of study drug.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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 Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: events
Mild 13
Moderate 11
Severe 4
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Varenicline
Hide Arm/Group Description 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.
All-Cause Mortality
Varenicline
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline
Affected / at Risk (%)
Total   1/16 (6.25%) 
Gastrointestinal disorders   
Intestinal obstruction * 1  1/16 (6.25%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Varenicline
Affected / at Risk (%)
Total   9/16 (56.25%) 
Cardiac disorders   
Tachycardia * 1  1/16 (6.25%) 
Gastrointestinal disorders   
Abdominal pain * 1  1/16 (6.25%) 
Dyspepsia * 1  1/16 (6.25%) 
Nausea * 1  3/16 (18.75%) 
Vomiting * 1  2/16 (12.50%) 
General disorders   
Asthenia * 1  1/16 (6.25%) 
Feeling abnormal * 1  1/16 (6.25%) 
Infections and infestations   
Gastroenteritis * 1  1/16 (6.25%) 
Viral rhinitis * 1  1/16 (6.25%) 
Injury, poisoning and procedural complications   
Incision site pain * 1  1/16 (6.25%) 
Investigations   
Transaminases increased * 1  1/16 (6.25%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  2/16 (12.50%) 
Hypocalcaemia * 1  1/16 (6.25%) 
Psychiatric disorders   
Abnormal dreams * 1  1/16 (6.25%) 
Decreased interest * 1  1/16 (6.25%) 
Insomnia * 1  3/16 (18.75%) 
Libido decreased * 1  1/16 (6.25%) 
Mental disorder * 1  1/16 (6.25%) 
Respiratory, thoracic and mediastinal disorders   
Productive cough * 1  1/16 (6.25%) 
Vascular disorders   
Hypertension * 1  1/16 (6.25%) 
Lymphoedema * 1  1/16 (6.25%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
This study was terminated after 16 of 100 planned subjects were enrolled due to slow recruitment and non-compliance with the protocol; only selected efficacy listings of the surgical population and key safety data were reported.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00889720     History of Changes
Other Study ID Numbers: A3051113
First Submitted: April 28, 2009
First Posted: April 29, 2009
Results First Submitted: July 27, 2011
Results First Posted: August 25, 2011
Last Update Posted: October 17, 2011