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It is possible to offer smoking cessation treatment including varenicline to patients scheduled for elective surgery. This study will evaluate whether or not this will enable some patients to quit smoking for up to 4 weeks prior to surgery and in turn, whether this may lead to reductions in post-operative complication such as wound infections.
Recruitment to this study was terminated (on February 23, 2010) earlier than originally planned because recruitment was much slower than expected and therefore the study has already achieved its main objective of assessing the feasibility of conducting a larger study of similar design to investigate the efficacy of smoking cessation therapy in a pre-surgical setting. The decision to end recruitment to the trial was not based on any safety concerns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smoking cessation tratment including varenicline | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | Varenicline film coated tablets - escalating dose with maximum dose of 1mg bd |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Fully Compliant Participants | 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. | Baseline through Week 12 |
| Number of Participants With Surgical Site Infection Post-surgery Days 1 to 3: Center for Disease Control (CDC) Definition | 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. | Post-surgery Days 1-3 |
| Number of Participants With Surgical Site Infection Post-surgery Days 6 to 10: Center for Disease Control (CDC) Definition | 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. | Post-surgery Days 6-10 |
| Number of Participants With Surgical Site Infection at Week 12: Center for Disease Control (CDC) Definition | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Paris | 75651 | France | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Fully Compliant Participants | 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. | 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. | Posted | Number | percentage of participants | Baseline through Week 12 |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Week 12 |
| Number of Participants With Surgical Site Infection at Week 26: Center for Disease Control (CDC) Definition | 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. | Week 26 |
| Number of Participants With Surgical Site Infections With Microbiological Confirmation of Bacterial Infection | Microbiological confirmation defined as organisms isolated from an aseptically obtained culture of fluid or tissues from the superficial incision. | Post-surgery Days 1-3, Post-surgery Days 6-10, Week 12, Week 26 |
| 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 = 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. | Post-surgery Days 1-3 |
| 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 = 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. | Post-surgery Days 6-10 |
| Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 12: Southampton Wound Assessment Scale | 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. | Week 12 |
| Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 26: Southampton Wound Assessment Scale | 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. | Week 26 |
| Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 1 to 3 | 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. | Post-surgery Days 1-3 |
| Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 6 to 10 | 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. | Post-surgery Days 6-10 |
| Wound Healing Grade by ASEPSIS Criteria at Week 12 | 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. | Week 12 |
| Wound Healing Grade by ASEPSIS Criteria at Week 26 | 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. | Week 26 |
| Number of Participants With 7 Day Point Prevalence (PP) for Smoking Abstinence Prior to Hospital Admission. | 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). | 7 days prior to hospital admission to day of hospital admission (after Week 8 of treatment) |
| Baseline through Week 26 |
| Percentage of Participants Who Succeed in Reducing Their Cigarette Consumption by at Least 50% in 7 Days Preceding Hospital Admission Compared With Baseline. | Baseline, Week 8 |
| 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) | 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). | Week 12 |
| Number of Participants With 7 Day Point Prevalence (PP) for Abstinence in the Week Preceding Week 26 | 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). | Week 26 |
| Percentage of Participants Who Reduced Their Cigarette Consumption by at Least 50% in the 7 Days Preceding Weeks 12 and 26 Compared With Baseline. | Baseline, Week 12, Week 26 |
| Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline | 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. | Baseline through Week 26 (within 30 days of last dose) |
| Number of Treatment Emergent Adverse Events by Severity | 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. | Baseline through Week 26 (within 30 days of last dose) |
| Pisa |
| 56124 |
| Italy |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Primary | Number of Participants With Surgical Site Infection Post-surgery Days 1 to 3: Center for Disease Control (CDC) Definition | 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. | Surgical Population; N= number of participants with a Day 1-3 post-surgery visit. | Posted | Number | participants | Post-surgery Days 1-3 |
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| Primary | Number of Participants With Surgical Site Infection Post-surgery Days 6 to 10: Center for Disease Control (CDC) Definition | 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. | Surgical Population; N= number of participants with a Day 6-10 post-surgery visit. | Posted | Number | participants | Post-surgery Days 6-10 |
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| Primary | Number of Participants With Surgical Site Infection at Week 12: Center for Disease Control (CDC) Definition | 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. | Surgical Population; N= number of participants with a Week 12 visit. | Posted | Number | participants | Week 12 |
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| Primary | Number of Participants With Surgical Site Infection at Week 26: Center for Disease Control (CDC) Definition | 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. | Surgical Population; N= number of participants with a Week 26 visit. | Posted | Number | participants | Week 26 |
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| Primary | Number of Participants With Surgical Site Infections With Microbiological Confirmation of Bacterial Infection | Microbiological confirmation defined as organisms isolated from an aseptically obtained culture of fluid or tissues from the superficial incision. | Surgical Population; Due to satisfactory wound healing in all subjects, microbiological assessment was not necessary and no swabs were taken. | Posted | Number | participants | Post-surgery Days 1-3, Post-surgery Days 6-10, Week 12, Week 26 |
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| Primary | 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 = 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. | Surgical Population; N= number of participants with a Day 1-3 post-surgery visit. | Posted | Number | participants | Post-surgery Days 1-3 |
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| Primary | 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 = 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. | Surgical Population; N= number of participants with a Day 6-10 post-surgery visit. | Posted | Number | participants | Post-surgery Days 6-10 |
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| Primary | Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 12: Southampton Wound Assessment Scale | 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. | Surgical Population; N= number of participants with a Week 12 visit. | Posted | Number | participants | Week 12 |
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| Primary | Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 26: Southampton Wound Assessment Scale | 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. | Surgical Population; N= number of participants with a Week 26 visit. | Posted | Number | participants | Week 26 |
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| Primary | Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 1 to 3 | 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. | Surgical Population; N= number of participants who had ASEPSIS wound grading during the study and had a Day 1-3 post-surgery visit. | Posted | Number | participants | Post-surgery Days 1-3 |
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| Primary | Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 6 to 10 | 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. | Surgical Population; N= number of participants who had ASEPSIS wound grading during the study and had a Day 6-10 post-surgery visit. | Posted | Number | participants | Post-surgery Days 6-10 |
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| Primary | Wound Healing Grade by ASEPSIS Criteria at Week 12 | 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. | Surgical Population; N = number of participants who had ASEPSIS wound grading during the study and had a Week 12 visit. | Posted | Number | participants | Week 12 |
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| Primary | Wound Healing Grade by ASEPSIS Criteria at Week 26 | 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. | Surgical Population; N = number of participants who had ASEPSIS wound grading during the study and had a Week 24 visit. | Posted | Number | participants | Week 26 |
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| Primary | Number of Participants With 7 Day Point Prevalence (PP) for Smoking Abstinence Prior to Hospital Admission. | 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). | Surgical population: N = participants who took at least 1 dose of study medication and received planned surgery. | Posted | Number | participants | 7 days prior to hospital admission to day of hospital admission (after Week 8 of treatment) |
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| Secondary | Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System | 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. | 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. | Posted | Number | participants | Baseline through Week 26 |
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| Secondary | Percentage of Participants Who Succeed in Reducing Their Cigarette Consumption by at Least 50% in 7 Days Preceding Hospital Admission Compared With Baseline. | Surgical population. Not analyzed due the limited number of participants recruited. | Posted | Number | percentage of participants | Baseline, Week 8 |
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| Secondary | 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) | 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). | Surgical population: N = number of participants who had a Week 12 visit. | Posted | Number | participants | Week 12 |
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| Secondary | Number of Participants With 7 Day Point Prevalence (PP) for Abstinence in the Week Preceding Week 26 | 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). | Surgical population: N = number of participants who had a Week 26 visit. | Posted | Number | participants | Week 26 |
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| Secondary | Percentage of Participants Who Reduced Their Cigarette Consumption by at Least 50% in the 7 Days Preceding Weeks 12 and 26 Compared With Baseline. | Surgical population: Not analyzed due the limited number of participants recruited. | Posted | Number | percentage of participants | Baseline, Week 12, Week 26 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline | 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. | 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. | Posted | Number | participants | Baseline through Week 26 (within 30 days of last dose) |
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|
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| Secondary | Number of Treatment Emergent Adverse Events by Severity | 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. | Safety analysis set. N = number of treated subjects. Includes data up to 30 days after last dose of study drug. | Posted | Number | events | Baseline through Week 26 (within 30 days of last dose) |
|
|
|
| 1 |
| 16 |
| 9 |
| 16 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Viral rhinitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Incision site pain | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
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| Transaminases increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Decreased interest | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Libido decreased | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Mental disorder | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Lymphoedema | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
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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.
| D011810 | Quinoxalines |
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|
| Grade IIb |
|
| Not done |
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| 6-10 days PS: No post-operative complications |
|
| 6-10 days PS: Grade I |
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| 6-10 days PS: Grade II |
|
| 6-10 days PS: Not done |
|
| Week 12: No post-operative complications |
|
| Week 12: Grade II |
|
| Week 12: Grade IIIb |
|
| Week 12: Not done |
|
| Week 26: No post-operative complications |
|
| Week 26: Grade IIIb |
|
| Title | Measurements |
|---|---|
|
| Severe TEAE: treatment-related |
|
| SAE: all causalities |
|
| SAE: treatment-related |
|
| Title | Measurements |
|---|
|