protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03559205 | 12.1 | Dissemination policy | 12.1 Dissemination policy Findings of this study will be disseminated through patient forums, health partners, academic health sciences networks, commissioners and healthcare providers, national associations, appropriate groups within NHS England, and international organisations. A summary of the findings will be avail... | [] |
NCT03559205 | 12.2 | Authorship eligibility guidelines | 12.2 Authorship eligibility guidelines Criteria for the authorship of scientific papers have been developed by the International Committee of Medical Journal Editors (ICMJE), and to be designated as an author on a paper an individual must fulfil all four of the following criteria: - 1) Substantial contributions to the ... | [] |
NCT03559205 | 13 | REFERENCES | 13 REFERENCES - 1. Vos T et al. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Aug 22; 386: 743-800. - 2. https://www.englan... | [] |
NCT03559751 | 1 | SPONSOR AND KEY PERSONNEL CONTACT INFORMATION | 1. SPONSOR AND KEY PERSONNEL CONTACT INFORMATION | ANDSPONSOR1.ROLEIN STUDY | KEYPERSONNELNamE | CONTACTINFORMATIONCONTACTINFORMATION | |-------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------------... | [] |
NCT03559751 | 2 | PROTOCOL SYNOPSIS | 2. PROTOCOL SYNOPSIS Name of Sponsor/Company: 22nd Century Group Inc. Name of Finished Product: Very Low Nicotine (VLN) cigarettes (0.4 mg nicotine/gram of tobacco)
Study Title: Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Cigarettes with Characterization of Nicotine Exposure Profiles in Adult Smokers
... | [
"Study Title:",
"Principal Investigator:",
"Study Center:",
"Objectives:",
"Methodology:",
"Number of Subjects (Planned):",
"Criteria for Inclusion/Exclusion:",
"Test Product:",
"Reference products:",
"Duration of Study:",
"Criteria for Evaluation:",
"Pharmacodynamic Endpoints:",
"Part A (Ad... |
NCT03559751 | 4 | LIST OF ABBREVIATIONS AND DEFINITION OF TERMS | 4. LIST OF ABBREVIATIONS AND DEFINITION OF TERMS AE Adverse event AUC(controlled) Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time zero (defined as the start of controlled use to 180 minutes, or the last quantifiable concentration during that interval). AUC(uncont... | [] |
NCT03559751 | 5 | INTRODUCTION | 5. INTRODUCTION | [] |
NCT03559751 | 5.1 | Background | 5.1. Background With the introduction of the 2009 Family Smoking Prevention and Tobacco Control Act, the Food and Drug Administration (FDA) was granted the authority to regulate tobacco products including the nicotine content of cigarettes. In July 2017, FDA Commissioner Scott Gottlieb, M.D., announced the FDA's intent... | [] |
NCT03559751 | 5.2 | Study Rationale | 5.2. Study Rationale The purpose of the current study is to provide an abuse liability assessment of VLN cigarettes compared with own-brand cigarettes and nicotine polacrilex gum in current manufactured filtered king size cigarette smokers, as recommended in "FDA Draft Guidance for Industry Version: Amendment 1.0, 2.0,... | [] |
NCT03559751 | 6 | STUDY OBJECTIVES | 6. STUDY OBJECTIVES | [] |
NCT03559751 | 6.1 | Primary Objective | 6.1. Primary Objective The primary objective of the study is: ▪ To evaluate the abuse liability of VLN cigarettes (0.4 mg nicotine/gram of tobacco) relative to own-brand cigarettes and nicotine polacrilex gum under controlled use and uncontrolled use conditions. | [] |
NCT03559751 | 6.2 | Secondary Objectives | 6.2. Secondary Objectives The secondary objectives of the study are: - To compare the nicotine pharmacokinetic (PK) profiles of VLN cigarettes relative to own-brand cigarettes and nicotine polacrilex gum under controlled use and uncontrolled use conditions. - To characterize product use behavior of VLN cigarettes, own-... | [] |
NCT03559751 | 7 | INVESTIGATIONAL PLAN | 7. INVESTIGATIONAL PLAN | [] |
NCT03559751 | 7.1 | Overall Study Design and Plan | 7.1. Overall Study Design and Plan This study will be a randomized, two-part, 3-way crossover designed to evaluate the abuse liability, PK, and product use behavior associated with study products, including VLN cigarettes, subjects' own-brand cigarettes, and nicotine polacrilex gum in healthy adult male and female excl... | [] |
NCT03559751 | 7.1.1 | Screening Phase (Visit 1) | 7.1.1. Screening Phase (Visit 1) The Screening Phase will be completed during a clinic visit within 28 days of the Confined Assessment Phase and will consist of a standard medical screen. | [] |
NCT03559751 | 7.1.2 | Confined Assessment Phase (Visit 2) | 7.1.2. Confined Assessment Phase (Visit 2) | [] |
NCT03559751 | 7.1.2.1 | Check-in and Product Trial (Day -1) | 7.1.2.1. Check-in and Product Trial (Day -1) Subjects who successfully complete the Screening Phase will return to the clinical unit on Day -1 for check-in and to complete a product trial session. Subjects will engage in a 10-minute product training session with the nicotine polacrilex gum in order to familiarize thems... | [] |
NCT03559751 | 7.1.2.2 | Part A (Day 1 to 3) | 7.1.2.2. Part A (Day 1 to 3) On Day 1, subjects will be randomized to one of three product sequence groups in Part A, which will consist of an ad libitum product use session of each of the following study products for 4 hours in a randomized crossover manner (one product per day): - Product A: VLN cigarette - Product B... | [] |
NCT03559751 | 7.1.2.3 | Part B (Day 4 to 6) | 7.1.2.3. Part B (Day 4 to 6) Upon completion of Part A, subjects will be randomized to one of three product sequence groups in Part B, which will consist of 3 study days (Days 4 to 6), with one product per day. Each study day will consist of: 1) Controlled Product Use Session (10 puffs from their own-brand cigarette or... | [] |
NCT03559751 | 7.1.3 | End of Study or Early Termination | 7.1.3. End of Study or Early Termination Subjects will be discharged from the clinic on Day 6 once all procedures are completed (or at Early Termination). The maximum duration of subject participation, including Screening will be approximately 5 weeks. An overview of the study design is provided in [Figure](#page-22-0)... | [] |
NCT03559751 | 7.2 | Discussion of Study Design | 7.2. Discussion of Study Design The overall study design is consistent with similar publicly available clinical studies conducted with cigarettes, non-combustible nicotine products (i.e., e-cigarettes) or nicotine replacement therapy in that it will be conducted using a randomized, cross-over design. This approach cont... | [] |
NCT03559751 | 8 | SELECTION OF STUDY POPULATION | 8. SELECTION OF STUDY POPULATION An appropriate number of subjects will be randomized on Day 1 (Part A) to ensure that a minimum of 54 subjects complete the study. | [] |
NCT03559751 | 8.1 | Inclusion Criteria | 8.1. Inclusion Criteria Subjects must meet each one of the following inclusion criteria in order to be eligible for participation in the study: - 1. Must provide written informed consent prior to the initiation of any protocol-specific procedures. - 2. Male and female adults, between 22 to 65 years of age, inclusive. -... | [] |
NCT03559751 | 8.2 | Exclusion Criteria | 8.2. Exclusion Criteria Subjects will not be eligible to participate in this study if any one of the following exclusion criteria is met: - 1. Inability to tolerate 4 mg nicotine polacrilex gum during product use trial on Day -1 (checkin) or dentition prevents subjects from chewing gum. - 2. History or presence of any ... | [] |
NCT03559751 | 8.3 | Removal of Subjects from or Assessment | 8.3. Removal of Subjects from or Assessment A subject is free to withdraw his/her consent and discontinue participation in the study at any time for any reason. A subject may also be discontinued from the study, at the discretion of an investigator and/or sponsor, for any of the following reasons: - Entered the study i... | [] |
NCT03559751 | 8.4 | Study Restrictions | 8.4. Study Restrictions In addition to the inclusion/exclusion criteria described in Section [8,](#page-28-0) the subject must agree to abide by the following study restrictions: - Subjects will be asked to abstain from alcohol for 48 hours prior to Screening and prior to admission to the Confined Assessment Phase unti... | [] |
NCT03559751 | 9 | MATERIALS | 9. MATERIALS | [] |
NCT03559751 | 9.1 | Study Products | 9.1. Study Products The following products will be used during the Confined Assessment Phase: - Product A: VLN cigarette (0.4 mg nicotine/gram of tobacco) - Product B: Subjects' Own-brand non-menthol filtered standard king size cigarettes (reference product) - Product C: Nicorette® Original Flavor™ nicotine polacrilex ... | [] |
NCT03559751 | 9.2 | Identity of Investigational Product(s) | 9.2. Identity of Investigational Product(s) The VLN cigarettes will be provided by the Sponsor. Subjects will supply their own-brand cigarettes with 2 unopened packs (20 cigarettes/pack x 2). The nicotine polacrilex gum will be acquired by the study site pharmacy. The study site will coordinate shipping of the study pr... | [] |
NCT03559751 | 9.2.1 | Handling, Storage, and Accountability | 9.2.1. Handling, Storage, and Accountability Study products (not including own-brand cigarettes) will be transported, received, stored, and handled strictly in accordance with the container or product label, the instructions provided to the research site, the site's standard operating procedures, and applicable regulat... | [] |
NCT03559751 | 9.2.2 | Dispensing and Administration | 9.2.2. Dispensing and Administration Individual study product dispensing records will be maintained by the site pharmacy for each subject. Study products for dispensing to subjects will be prepared each day. Fresh packs of cigarettes will also be used each study day from which the cigarettes will be provided (Product A... | [] |
NCT03559751 | 9.3 | Method of Assigning Subjects to Study Groups | 9.3. Method of Assigning Subjects to Study Groups Each potential subject will be assigned a unique number in the screening process (subject number). This number will be used to identify the subject throughout the study. Algorithme Pharma Inc. will prepare the randomization schedule with a computer program according to ... | [] |
NCT03559751 | 9.4 | Selection and Timing of Product Use | 9.4. Selection and Timing of Product Use First product administration will occur in the morning on each study day (Days 1 through 6), after approximately 20 hours of nicotine abstinence. Subjects will be segregated in different areas of the facility based on the product that they are receiving so that odors and sight o... | [] |
NCT03559751 | 9.4.1 | Part A (Days 1 to 3) | 9.4.1. Part A (Days 1 to 3) On each of the 3 days, subjects will use only one of the 3 study products according to their randomization sequence. No other use of tobacco- or nicotine-containing products will be allowed from check-in on Day -1 through to End of Study discharge except as required by this protocol, and sub... | [] |
NCT03559751 | 9.4.1.1 | Product A: VLN Cigarettes | 9.4.1.1. Product A: VLN Cigarettes Subjects will be assigned an unopened pack of VLN cigarettes. They will be presented to the subjects unbranded. Subjects will have open access to the cigarettes and may smoke the cigarettes as desired during the 4-hour session. Study staff will record the number of cigarettes dispense... | [] |
NCT03559751 | 9.4.1.2 | Product B: Own-brand Cigarettes | 9.4.1.2. Product B: Own-brand Cigarettes Subjects will be assigned an unopened pack of their own-brand cigarettes. Subjects will have open access to the cigarettes and may smoke the cigarettes as desired during the 4-hour session. Clinic staff will record the number of cigarettes dispensed, time dispensed, and number o... | [] |
NCT03559751 | 9.4.1.3 | Nicotine Polacrilex Gum | 9.4.1.3. Nicotine Polacrilex Gum Subjects will be assigned unopened pack of 4 mg nicotine polacrilex gum. Subjects will have open access to nicotine polacrilex gum and may chew the gum as desired during the 4-hour session. Clinic staff will record the number of gum pieces dispensed to subjects and will record the amoun... | [] |
NCT03559751 | 9.4.2 | Part B (Days 4 to 6) | 9.4.2. Part B (Days 4 to 6) On each of the 3 days, subjects will use only one of the 3 study products according to their randomization sequences. No other use of tobacco- or nicotine-containing products will be allowed. | [] |
NCT03559751 | 9.4.2.1 | Product A: VLN Cigarettes | 9.4.2.1. Product A: VLN Cigarettes During the first product use session (i.e., Controlled Use), subjects will take 10 puffs of one of the VLN cigarettes at approximately 30-second intervals (± 5 seconds) based off the start of inhalation, inhalation duration will not exceed 3 ± 2 seconds per puff. The clinic staff will... | [] |
NCT03559751 | 9.4.2.2 | Product B: Own-brand Cigarettes | 9.4.2.2. Product B: Own-brand Cigarettes During the first product use session (i.e., Controlled Use), subjects will take 10 puffs of one of their own-brand cigarettes at approximately 30-second intervals (± 5 seconds) based off the start of inhalation, inhalation duration will not exceed 3 ± 2 seconds per puff. The cli... | [] |
NCT03559751 | 9.4.2.3 | Product C: Nicotine Polacrilex Gum | 9.4.2.3. Product C: Nicotine Polacrilex Gum During the first product use session (i.e., Controlled Use), subjects will chew the 4 mg nicotine polacrilex gum product according to the package instructions: The gum is to be chewed slowly until a tingling sensation is felt in the mouth, "parked" between the cheek and gum u... | [] |
NCT03559751 | 9.5 | Meal Schedule | 9.5. Meal Schedule On Day -1, meals and snacks will be served at appropriate times as determined by the clinic based on the time of Check-in. Standard meals will be served on Days 1 to 3. Subjects will be served a light breakfast each morning and must complete breakfasts on the mornings of Days 4 to 6 at least 1 hour p... | [] |
NCT03559751 | 9.6 | Blinding | 9.6. Blinding The study design is not blinded since subjects will know if the product is a VLN cigarette, their own cigarette or a nicotine polacrilex gum. The study product codes will be open to all study staff and to the Sponsor. The randomization code will not be available to the personnel of the bioanalytical facil... | [] |
NCT03559751 | 9.7 | Prior and Concomitant Therapy | 9.7. Prior and Concomitant Therapy All medications, including prescription, over-the-counter, or herbal therapies used by the subjects will be documented for the 30 days prior to Screening and throughout the study. An investigator will determine if the prior/concomitant medication(s) affect the subject's eligibility to... | [] |
NCT03559751 | 9.8 | Product Compliance | 9.8. Product Compliance Study products will be administered under the supervision of study personnel, and compliance with protocol-specified procedures during the Controlled Use Sessions will be monitored by study personnel. Version: Amendment 1.0, 2.0, 11APR2018 Page 36 of 65 | [] |
NCT03559751 | 10 | STUDY PROCEDURES AND ASSESSMENTS | 10. STUDY PROCEDURES AND ASSESSMENTS All study assessments will be performed at the visits and timepoints outlined in the Schedule of Assessments [\(Table](#page-23-0) 1); the following sections outline the details and procedures associated with the assessments. Other logistical considerations (e.g., sequence of events... | [] |
NCT03559751 | 10.1 | Demographics and Other Baseline Characteristics | 10.1. Demographics and Other Baseline Characteristics | [] |
NCT03559751 | 10.1.1 | Informed Consent | 10.1.1. Informed Consent The nature of the study and its risks and benefits will be explained to the subject by an investigator or designated study personnel. The subject must provide written informed consent on an ethics-approved informed consent form (ICF), prior to performing any study-related procedures. A copy of ... | [] |
NCT03559751 | 10.1.2 | Demographics | 10.1.2. Demographics The following demographics will be recorded: age (birthdate), sex, race, and ethnicity. | [] |
NCT03559751 | 10.1.3 | Medical History | 10.1.3. Medical History The complete medical history will include histories of acute, chronic, or infectious disease; surgical or oncologic histories; and any reported conditions affecting major body systems. All findings on medical history will be evaluated by an investigator for clinical significance. Medical histori... | [] |
NCT03559751 | 10.1.4 | Medication and Smoking History | 10.1.4. Medication and Smoking History All medications (prescription and non-prescription, herbal medications/natural health products, or investigational drugs) taken by the subjects during the 30 days prior to Screening will be recorded in the source documentation as medication history. A history of tobacco use/histor... | [] |
NCT03559751 | 10.2 | Pharmacodynamic Measures | 10.2. Pharmacodynamic Measures On Day -1, subjects will complete a training session during which they will complete the subjective questionnaires in order to familiarize themselves with the questions, appropriate use of the VAS, and use of the computerized tablet system. | [] |
NCT03559751 | 10.2.1 | Tobacco/Nicotine Withdrawal Scale | 10.2.1. Tobacco/Nicotine Withdrawal Scale The Tobacco/Nicotine Withdrawal items are administered as 100 point VAS, and are intended to measure withdrawal symptoms and craving (adapted from Hughes & [Hatsukami,](#page-59-9) 1986; Appendix [17.2.1\)](#page-62-1). The VAS is anchored with "Not at All" on the left and "Ext... | [] |
NCT03559751 | 10.2.2 | Direct Effects of Product Questionnaire | 10.2.2. Direct Effects of Product Questionnaire The Direct Effects of Product items are administered as 100 point VAS, and are intended to measure the effects of the product being sampled at the moment (Appendix [17.2.2\)](#page-63-0). The VAS is anchored with "Not at All" on the left and "Extremely" on the right. The ... | [] |
NCT03559751 | 10.2.3 | Use the Product Again Questionnaire | 10.2.3. Use the Product Again Questionnaire The Use the Product Again questionnaire is a bipolar 100 point VAS used to assess how much a subject would be willing to use the sampled product again (Appendix [17.2.3\)](#page-63-1). The VAS is anchored by "Definitely Would Not" on the left and "Definitely Would" on the rig... | [] |
NCT03559751 | 10.2.4 | Product Use | 10.2.4. Product Use Number of own-brand cigarettes and VLN cigarettes smoked and number of nicotine polacrilex gum pieces chewed and duration of gum in mouth will be recorded during the ad libitum product use sessions in Part A. During the Uncontrolled Use Sessions in Part B, number of inhalations and duration of each ... | [] |
NCT03559751 | 10.3 | Safety Assessments | 10.3. Safety Assessments | [] |
NCT03559751 | 10.3.1 | Adverse Events and Serious Adverse Events | 10.3.1. Adverse Events and Serious Adverse Events An investigator and research site staff are responsible for the detection, documentation, classification, reporting, and follow-up of events meeting the definition of an AE or serious adverse event (SAE). All AEs will be recorded following informed consent (at Screening... | [] |
NCT03559751 | 10.3.1.1 | Adverse Events | 10.3.1.1. Adverse Events An AE is any untoward medical occurrence in a clinical investigation subject administered a product and may not necessarily have a causal relationship with the administered treatment. An AE can, therefore, be any unfavorable and unintended sign (including a clinically significant laboratory abn... | [] |
NCT03559751 | 10.3.1.2 | Serious Adverse Events and Serious Unexpected Adverse Events | 10.3.1.2. Serious Adverse Events and Serious Unexpected Adverse Events An SAE is any untoward medical occurrence that at any product use: - Results in death; - Is life-threatening (at the time of the event); - Requires inpatient hospitalization or prolongation of existing hospitalization; - Results in persistent or sig... | [] |
NCT03559751 | 10.3.1.3 | Clinical Laboratory Abnormalities and Other Abnormal Assessments | 10.3.1.3. Clinical Laboratory Abnormalities and Other Abnormal Assessments Abnormal clinical laboratory findings (e.g., clinical chemistry, hematology, or urinalysis) or other abnormal assessments (e.g., from vital signs or ECG), judged as clinically significant by an investigator will be recorded as AEs or SAEs, if th... | [] |
NCT03559751 | 10.3.1.4 | Classification of Adverse Event Intensity and Causality | 10.3.1.4. Classification of Adverse Event Intensity and Causality For each recorded AE or SAE, an investigator must make an assessment of intensity based on the following criteria: Mild: An event that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally i... | [] |
NCT03559751 | 10.3.1.5 | Follow-up of Adverse Events and Serious Adverse Events | 10.3.1.5. Follow-up of Adverse Events and Serious Adverse Events All unresolved AEs will be followed for a minimum of 14 days after the subject's final Study Day, unless an investigator's judgment dictates otherwise, the event has resolved or stabilized before the 14-day period, or the subject is lost to follow-up. Ver... | [] |
NCT03559751 | 10.3.2 | Pregnancy | 10.3.2. Pregnancy If a subject becomes pregnant during the study or for 14 days after the final Study Day, an investigator will report the pregnancy to 22nd Century Inc. or designee within 24 hours of learning of the event. Any subject who becomes pregnant during the study will be immediately withdrawn from the study. ... | [] |
NCT03559751 | 10.3.3 | Clinical Laboratory Assessments | 10.3.3. Clinical Laboratory Assessments Blood and urine samples will be collected, processed, and shipped according to the research site's standard operating procedures and instructions from the safety laboratory. Samples will be Version: Amendment 1.0, 2.0, 11APR2018 Page 42 of 65 segregated in such a way as to minimi... | [] |
NCT03559751 | 10.3.4 | Urine Drug Screen and Alcohol Testing | 10.3.4. Urine Drug Screen and Alcohol Testing Urine drug screens will test for the following drugs of abuse: tetrahydrocannabinol (THC), opioids, amphetamines, cocaine, and benzodiazepines. The opioid panel will include morphine, codeine, heroin, hydrocodone, hydromorphone, and oxycodone. Version: Amendment 1.0, 2.0, 1... | [] |
NCT03559751 | 10.3.5 | Vital Signs | 10.3.5. Vital Signs Vital signs will consist of blood pressure (systolic and diastolic blood pressure, mmHg), pulse rate (beats per minute), and respiratory rate (breaths/min). Oral temperature (°C) will also be taken at some time points, as specified in [Table](#page-23-0) 1. Vitals signs will be collected and managed... | [] |
NCT03559751 | 10.3.6 | 12-lead Electrocardiograms | 10.3.6. 12-lead Electrocardiograms ECGs will be performed after the subject has been resting in a recumbent/supine position for at least 3 minutes. The ECG variables will include ventricular heart rate and the PR, QRS, QT, QTcB and QTcF intervals. 12-lead ECGs will be performed and interpreted according to the site's s... | [] |
NCT03559751 | 10.3.7 | Physical Examination | 10.3.7. Physical Examination A complete physical examination, assessing the subject's overall health and physical condition, will be performed at Screening according to the site's standard operating procedures. A brief, symptom-driven physical will be conducted on Day -1 and End of Study Day 6. Height, weight and BMI w... | [] |
NCT03559751 | 10.4 | Pharmacokinetic Assessments | 10.4. Pharmacokinetic Assessments Venous blood samples will be collected to determine the plasma concentrations of nicotine at the timepoints outlined in the Schedule of Assessments [\(Table](#page-23-0) 1). Samples will be collected, processed, and shipped according to the site's standard operating procedures and inst... | [] |
NCT03559751 | 10.5 | Appropriateness of Measures | 10.5. Appropriateness of Measures The selection of abuse liability measures in this study, including the primary endpoints of "Urges to Smoke" and "Pleasant" Emax during the Controlled Use Session are consistent with previous studies of this type. The Use the Product Again VAS is being used as this is thought to indica... | [] |
NCT03559751 | 10.6 | Pharmacodynamic Variables | 10.6. Pharmacodynamic Variables | [] |
NCT03559751 | 10.6.1 | Primary Pharmacodynamic Endpoints | 10.6.1. Primary Pharmacodynamic Endpoints The primary endpoints of this study are as follows: - Controlled Product Use (Part B) - o Emax\urge(controlled): The maximum reduction in VAS score for the question "Urges to smoke" (Tobacco/Nicotine Withdrawal Questionnaire) between pre-use and post-use (i.e., VASpre-use1 – VA... | [] |
NCT03559751 | 10.6.2 | Secondary Endpoints | 10.6.2. Secondary Endpoints The secondary endpoints of this study are as follows: - Ad libitum Product Use (Part A) - o Use the Product Again VAS score - o Product use behavior (number of units consumed, time spent per unit, number of inhalations per cigarette, duration of gum in mouth) - Controlled and Uncontrolled Pr... | [] |
NCT03559751 | 10.7 | Pharmacokinetic Variables | 10.7. Pharmacokinetic Variables The PK parameters of nicotine will include, but are not limited to, the following: - Cmax(controlled): Maximum measured plasma nicotine concentration during the Controlled Use Session. - Cmax(uncontrolled): Maximum measured plasma nicotine concentration during the Uncontrolled Use Sessio... | [] |
NCT03559751 | 10.8 | Safety Variables | 10.8. Safety Variables The safety endpoints include the following: - AEs (incidence, frequency, severity and relationship to product), SAEs, and AEs leading to discontinuation; - Vital signs (heart rate, blood pressure, respiratory rate, oral temperature); - 12-lead ECG; - Clinical laboratory tests (clinical chemistry,... | [] |
NCT03559751 | 11 | DATA QUALITY ASSURANCE | 11. DATA QUALITY ASSURANCE This study will be conducted under Good Clinical Practice (GCP) and all applicable regulatory requirements. To ensure compliance, the Sponsor or designee may conduct a quality assurance audit, as outlined in Section [11.2.](#page-47-2) Actions to ensure the accuracy and reliability of data in... | [] |
NCT03559751 | 11.1 | Data Collection | 11.1. Data Collection Source documents include but are not limited to original documents, data and records such as hospital/medical records (including electronic health records), clinic charts, lab results, subject diaries, data recorded in automated instruments, microfilm or magnetic media, and pharmacy records, etc. ... | [] |
NCT03559751 | 11.2 | Study Auditing and Monitoring | 11.2. Study Auditing and Monitoring Monitoring of the study site (including, but not limited to, reviewing CRFs for accuracy and completeness) will be performed by the Sponsor's monitor. The extent, nature, and frequency of on-site visits will be based on such considerations as the study objectives and/or endpoints, th... | [] |
NCT03559751 | 12 | STATISTICAL METHODS AND DETERMINATION OF SAMPLE SIZE | 12. STATISTICAL METHODS AND DETERMINATION OF SAMPLE SIZE | [] |
NCT03559751 | 12.1 | Statistical and Analytical Plans | 12.1. Statistical and Analytical Plans Complete details of the statistical analyses to be performed will be documented in a statistical analysis plan (SAP), which will be finalized prior to completion of the study. This document will include more detail of analysis populations, summary strategies, and any amendments to... | [] |
NCT03559751 | 12.2 | Determination of Sample Size | 12.2. Determination of Sample Size Sample size estimation was performed on both pharmacodynamic endpoints. Using a 2-sided Type I error rate at α=0.05 and assuming a mean difference in Emax\urge(controlled) between own-brand cigarette and nicotine polacrilex gum of 15.85 points and standard deviation (SD) of 28.44, 54 ... | [] |
NCT03559751 | 12.3 | Analysis Populations | 12.3. Analysis Populations The study analysis populations will consist of - Randomized Population (Part A): All subjects who are randomized into Part A. - Randomized Population (Part B): All subjects who are randomized into Part B. - Safety Population: All randomized subjects who use at least one of the study products.... | [] |
NCT03559751 | 12.4 | Planned Analyses | 12.4. Planned Analyses | [] |
NCT03559751 | 12.4.1 | Subject Disposition | 12.4.1. Subject Disposition Disposition of each analysis population will be summarized using descriptive statistics. Data from subjects who discontinue from the study will also be summarized by last product used and reason for discontinuation. | [] |
NCT03559751 | 12.4.2 | Demographics and Other Baseline Characteristics | 12.4.2. Demographics and Other Baseline Characteristics Descriptive statistics will be reported for continuous demographic variables (age, weight, height, and BMI) and frequency counts will be tabulated for categorical demographics variables (gender, ethnicity, and race). In addition, number of cigarettes smoked per da... | [] |
NCT03559751 | 12.4.3 | Analysis of Pharmacodynamic Measures | 12.4.3. Analysis of Pharmacodynamic Measures | [] |
NCT03559751 | 12.4.3.1 | Part A | 12.4.3.1. Part A Responses to Use the Product Again VAS will be summarized by study product using descriptive statistics (n, mean, SD, median, Q1, Q3, min, max). A summary table of frequencies may also be provided. Descriptive statistics (n, mean, SD, median, Q1, Q3, min, max) will be provided for amount of product use... | [] |
NCT03559751 | 12.4.3.2 | Part B | 12.4.3.2. Part B Responses to each Tobacco/Nicotine Withdrawal Questionnaire and Direct Effects of Product Questionnaire item will be summarized by time point for each study product, and product use condition. For Tobacco/Nicotine Withdrawal VAS scores, descriptive statistics (n, mean, SD, median, Q1, Q3, min, max) for... | [] |
NCT03559751 | 12.4.3.3 | Adjustment for Covariates | 12.4.3.3. Adjustment for Covariates Baseline (pre-use) score will be included as a covariate for all pharmacodynamics measures for which a pre-use score is collected. | [] |
NCT03559751 | 12.4.3.4 | Handling of Dropouts or Missing Data | 12.4.3.4. Handling of Dropouts or Missing Data Missing pharmacodynamic data, including reasons for the missing data, will be listed by subject and examined on a case-by-case basis to determine if these affect subject allocation. No imputation of missing pharmacodynamic data will be performed. | [] |
NCT03559751 | 12.4.3.5 | Interim Analyses and Data Monitoring | 12.4.3.5. Interim Analyses and Data Monitoring No interim analyses will be performed. | [] |
NCT03559751 | 12.4.3.6 | Multiple Comparison/Multiplicity | 12.4.3.6. Multiple Comparison/Multiplicity Multiple comparison adjustments will not be made. | [] |
NCT03559751 | 12.4.3.7 | Tabulation of Individual Response Data | 12.4.3.7. Tabulation of Individual Response Data Individual subject pharmacodynamic data will be listed by measure and timepoint. A by-subject listing of derived pharmacodynamic endpoints (e.g., Emax, etc.) will also be provided. | [] |
NCT03559751 | 12.4.4 | Analysis of Pharmacokinetics | 12.4.4. Analysis of Pharmacokinetics Refer to the SAP for details on analysis of PK. Descriptive statistics of plasma nicotine concentrations will be tabulated by time point for each study product and product use condition. Derived PK parameters (both unadjusted and baseline Version: Amendment 1.0, 2.0, 11APR2018 Page ... | [] |
NCT03559751 | 12.4.5 | Analysis of Safety Assessments | 12.4.5. Analysis of Safety Assessments A by-subject AE data listing, including verbatim term, preferred term, study product, severity, and relationship to study product, will be provided. Study product use–emergent AEs will be summarized with tables. Frequencies of subjects with AEs, SAEs and incidence of those events,... | [] |
NCT03559751 | 13 | STUDY ADMINISTRATION AND INVESTIGATOR RESPONSIBILITIES | 13. STUDY ADMINISTRATION AND INVESTIGATOR RESPONSIBILITIES Additional details may be outlined in the Clinical Study Agreement (CSA) between the Sponsor and the investigational site. | [] |
NCT03559751 | 13.1 | Regulatory and Ethical Considerations | 13.1. Regulatory and Ethical Considerations | [] |
NCT03559751 | 13.1.1 | Ethical Conduct of the Study | 13.1.1. Ethical Conduct of the Study An investigator will conduct the study in accordance with GCP and all applicable regulations, including, where applicable, the Declaration of Helsinki. The study will also be carried out in keeping with applicable national and local laws and regulations. This may include an inspecti... | [] |
NCT03559751 | 13.1.2 | Regulatory Authority and Ethics Approval | 13.1.2. Regulatory Authority and Ethics Approval The investigational site's IRB must meet all relevant regulatory requirements. The study protocol and ICF will be reviewed by the IRB prior to enrolling subjects into the study; written approval from the committee must be received by the Sponsor before study product will... | [] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.