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protocol_id stringclasses 263 values	section_number stringlengths 1 12	title stringlengths 1 1.88k	content stringlengths 0 866k	merged_titles listlengths 0 491
NCT01779375	7.1	Data and Safety Monitoring Board (DSMB)	7.1 Data and Safety Monitoring Board (DSMB) A DSMB comprised of appropriately qualified and conflict-free independent experts is appointed by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and provides input to the Institute. Board members are chosen by the NIDDK without consultation with ...	[]
NCT01779375	7.2	Data and Safety Monitoring Plan	7.2 Data and Safety Monitoring Plan	[]
NCT01779375	7.2.1	Informed Consent	7.2.1 Informed Consent Written informed consent will be obtained prior to initiation of any study-related activities. The informed consent process will be conducted by qualified study personnel. All participants must read, sign and date a consent/assent form as appropriate (consent for participants age 18 and above, as...	[]
NCT01779375	7.2.2	Safety Review Plan and Monitoring	7.2.2 Safety Review Plan and Monitoring - A. Justification of Sample Size – See Section 9.3. - B. Stopping Rules The DSMB may suggest terminating a study arm at any time for safety or efficacy reasons. Details of interim analysis plans and stopping rules can be found in Sections 9.4 and 9.5. - C. Safety Monitoring Comm...	[]
NCT01779375	7.2.3	Confidentiality	7.2.3 Confidentiality - A. Protection of subject privacy – Participants are identified within the study only by their RISE Participant ID. No personal identifiers are used in any data collection. - B. Database Protection All files are stored in a locked cabinet at the clinical centers, and data are entered into a secur...	[]
NCT01779375	7.3	Expected Side Effects	7.3 Expected Side Effects The RISE Pediatric Study will use the following medications: metformin and insulin glargine. Metformin: Known adverse effects associated with metformin are primarily gastrointestinal (diarrhea, nausea, vomiting, abdominal bloating, flatulence, anorexia), hematologic (reduced vitamin B12 levels...	[]
NCT01779375	7.4	Risk Management	7.4 Risk Management Glucose management (including study medications) will be provided free of charge to RISE Study participants while participating in the study. Participants will receive training about the proper use of hypoglycemic medications as well as education about the symptoms, causes and response to episodes o...	[]
NCT01779375	7.5	Potential Benefits	7.5 Potential Benefits There is potential benefit of participation by individuals with either prediabetes or type 2 diabetes. Prediabetic participants are at increased risk of developing diabetes and may benefit from the frequent monitoring and testing that will allow earlier recognition should their condition progress...	[]
NCT01779375	7.6	HIPAA – Protection of Patient Information	7.6 HIPAA – Protection of Patient Information All data collected in the process of pre-screening, screening, and conducting the proposed research will be stored and maintained locally and centrally in compliance with HIPAA regulations. Access to study data will be secure with limited, password-protected access. Only st...	[]
NCT01779375	8	ADVERSE EVENT REPORTING	8 ADVERSE EVENT REPORTING An adverse event is defined as any medical problem experienced by a RISE participant whether or not considered intervention-related by the clinical center staff. The timely and complete reporting of adverse events is a critical requirement in the conduct of this trial. This trial will be condu...	[]
NCT01779375	8.1	Definition of Serious Adverse Events	8.1 Definition of Serious Adverse Events - a. The event results in an inpatient hospitalization (any overnight stay associated with an admission). - b. The event results in the prolongation of a hospital stay. - c. The event results in permanent or severe disability. - d. The event results in death. - e. A pregnancy re...	[]
NCT01779375	8.2	Non-serious Adverse Events	8.2 Non-serious Adverse Events Non-serious adverse events are all AEs which do not meet the above criteria for "serious".	[]
NCT01779375	8.3	Reporting Adverse Events	8.3 Reporting Adverse Events AEs will be ascertained in an unbiased manner using standard questions that are identical and identically administered to participants in all treatment arms. To accomplish this, AEs will be reported on a standard form that is completed by the study staff at each regular study visit followin...	[]
NCT01779375	8.4	Tracking Adverse Events	8.4 Tracking Adverse Events - Serious Adverse Events: SAEs will be monitored by the RISE Safety Monitoring Committee, which will remain blinded to treatment arm. The external DSMB will monitor SAEs by treatment arm. It is important to note that all serious and unexpected AEs must be reported to the CoC, regardless of t...	[]
NCT01779375	8.5	Emergency Unmasking	8.5 Emergency Unmasking The Safety Monitoring Committee remains blinded to treatment group. If a SAE warrants unblinding, an on-call member of the Safety Monitoring Committee is available for consultation at all times. Unblinding will be performed by a selected member of the study group in combination with the CoC.	[]
NCT01779375	9	STATISTICAL CONSIDERATIONS	9 STATISTICAL CONSIDERATIONS All analyses will be conducted under the intention-to-treat principle using the treatment as assigned to each participant, and using all available data from all participants. Analyses of study data will be conducted to address the primary and secondary objectives of the trial, other stated ...	[]
NCT01779375	9.1	Primary Outcome and Analyses	9.1 Primary Outcome and Analyses Two primary outcomes each measuring ß-cell function after 3-months of washout will be assessed for this trial. Analysis of covariance will be used to compare the two intervention groups after the washout. All analyses will be adjusted for the baseline value of each outcome. Because we a...	[]
NCT01779375	9.2	Secondary Outcomes and Analyses	9.2 Secondary Outcomes and Analyses	[]
NCT01779375	9.2.1	Measures of ß- and -cell Function and Glucose Tolerance	9.2.1 Measures of ß- and -cell Function and Glucose Tolerance Comparisons of the primary study outcomes will be made for those with vs. without diabetes at study entry, by race/ethnicity and sex, by baseline HbA1c and ß-cell function, and by categorical groups of various biomarkers. Analysis of covariance will be used ...	[]
NCT01779375	9.3	Sample Size/Power Calculations	9.3 Sample Size/Power Calculations As this is a proof-of-principle trial, we have chosen 2 measures of ß-cell function as co-primary outcomes. They measure different components of ß-cell function, and we have no basis of determining whether one or the other is likely to change following the interventions. There is litt...	[]
NCT01779375	9.4	Interim Analysis Plans	9.4 Interim Analysis Plans The CoC will provide interim analyses of primary and major secondary trial outcomes to the DSMB on a predefined schedule. These results will not be shared with the study group unless the DSMB recommends early stopping of the trial.	[]
NCT01779375	9.5	Stopping Rules	9.5 Stopping Rules The DSMB will monitor trial outcomes as they emerge for futility with specific rules outlined in the DSMB Monitoring Plan. This trial will not be stopped for lack of efficacy, as it is a proof-ofprinciple study with small numbers of participants in each treatment arm.	[]
NCT01779375	9.6	Handling of Missing Data	9.6 Handling of Missing Data It is anticipated that a small number of participants will require immediate rescue therapy and be unable to have the 3-month post-washout evaluation. In these cases, the primary outcome will be missing. A sensitivity analysis which includes these participants will use a conservative approa...	[]
NCT01779375	10	DATA PROCESSING AND MANAGEMENT	10 DATA PROCESSING AND MANAGEMENT	[]
NCT01779375	10.1	Data Management System	10.1 Data Management System Data are entered by the clinical centers using a web data entry application that directly enters study data into the CoC's study database. The web application guides the clinical site staff member through the data entry process. If an invalid response is entered, the website signals and prov...	[]
NCT01779375	10.2	Data Transfer	10.2 Data Transfer Newly entered clinical center data are received by the CoC immediately upon data entry. The CoC merges newly received data with the accumulated data in a SAS database. Data transfer from central units such as the central laboratory will be through the CoC data management system.	[]
NCT01779375	10.3	Quality Control	10.3 Quality Control Range checks, inter-item checks, cross-table checks, and double data entry verification are used where appropriate to ensure accurate data entry. Specific quality control procedures are run to check for missing, incorrect, and questionable values immediately after they are entered. Reports with the...	[]
NCT01779375	10.4	Back-up, Data Security and Confidentiality	10.4 Back-up, Data Security and Confidentiality The CoC adheres to the George Washington University Biostatistics Center's data backup and security policies to ensure the safety and confidentiality of the data. Backup procedures include: twice-weekly system backup, daily incremental back-up, and off-site disaster recov...	[]
NCT01779375	10.5	Tracking Study Progress	10.5 Tracking Study Progress The purpose of tracking reports is to keep the collaborative group informed of study progress, and to report special problems and resolutions. Reports will be produced regularly by the CoC, as directed by the Steering Committee. These reports will be distributed to the study group through t...	[]
NCT01779375	10.6	Archiving and Study Close-out	10.6 Archiving and Study Close-out At the end of the study, after all data have been received and edited, the database is archived in computer readable format, including documentation files, files of study documents (such as forms annotated with variable names, protocols, and manuals of procedures), data files in the f...	[]
NCT01779375	11	STUDY ADMINISTRATION	11 STUDY ADMINISTRATION This randomized clinical trial is one of three studies conducted by the RISE Study Consortium. RISE is a collaborative study group funded by the NIDDK of the National Institutes of Health (NIH) under a cooperative agreement mechanism. The goal of the RISE Study is to test different interventions...	[]
NCT01779375	11.1	Organization	11.1 Organization The major organizational components and their responsibilities are described: - The RISE Steering Committee, comprised of the principal investigators of the clinical centers, the CoC, and the NIDDK project office, is the primary decision making body for the study with overall responsibility for the de...	[]
NCT01779375	11.2	Central Laboratories and Reading Centers	11.2 Central Laboratories and Reading Centers In collaboration with the CoC and study investigators, central laboratories and reading centers perform the following tasks: - 1. Establish procedures and standards for training staff involved in the measurement, collection, preparation, handling, transfer, and all other pr...	[]
NCT01779375	11.3	Training and Certification	11.3 Training and Certification During the start-up period, clinic staff will receive central training and certification at a training workshop held by the study group. The CoC staff and selected clinical center staff with expertise in various study components will provide instruction in all aspects of the study. The p...	[]
NCT01779375	11.4	Site Visits	11.4 Site Visits The Steering Committee will be responsible for ongoing monitoring of the performance of study components. There are two types of site visits that can be conducted (1) scheduled monitoring and (2) as needed to address specific problems. The RISE Study does not anticipate scheduled monitoring site visits...	[]
NCT01779375	11.5	Study Website	11.5 Study Website The CoC maintains the study website, which is a secure site requiring a user ID and password combination for access. The web server utilizes the Secure Socket Layer (SSL) protocol that encrypts all traffic to and from the server. Investigators, coordinators, consultants, and other study staff who wou...	[]
NCT01779375	11.6	Conflict of Interest Policy	11.6 Conflict of Interest Policy The RISE Study investigators have adopted a conflict of interest policy similar to that used by other NIDDK collaborative groups. On an annual basis or whenever there is a significant change in status, RISE collaborators are required to disclose any financial or related interest that co...	[]
NCT01779375	11.7	Publications and Presentations Policy	11.7 Publications and Presentations Policy The Publications and Presentations Subcommittee (PPS) will coordinate, monitor, review, and assume responsibility for overseeing the preparation of all study-wide communications (press releases, interviews, presentations (oral and posters), and publications) relating to the sc...	[]
NCT01779375	11.8	Ancillary Studies Policy	11.8 Ancillary Studies Policy The Ancillary Studies Subcommittee will evaluate all proposals for studies that involve RISE participants and/or data that are not a part of the protocol. These studies may be done in all RISE participants or only on a subset of participants in RISE. Ancillary studies may make use of data ...	[]
NCT01779375	11.9	Protocol Amendments	11.9 Protocol Amendments Adoption of protocol amendments requires two-thirds majority approval by voting members of the RISE Steering Committee and approval by the DSMB. The amended protocol is resubmitted to the IRB, and the participant consent is revised appropriately.	[]
NCT01779375	11.10	Repository for Storage and Distribution of RISE Data and Samples	11.10 Repository for Storage and Distribution of RISE Data and Samples At the end of the study, de-identified research data and samples of blood and urine will be provided to the NIDDK Central Repositories, a research resource supported by the National Institutes of Health. The Repository collects, stores, and distribu...	[]
NCT01779375	12	STUDY TIMELINE	12 STUDY TIMELINE The study timeline allows for recruitment over the first 3 years of the study, which commences after all approvals have been obtained (DSMB, FDA, IRBs, CTAs or CRADAs), central study training has been performed and all study medications and supplies have been procured. Intervention and washout phases ...	[]
NCT01779375	13	LITERATURE CITED	13 LITERATURE CITED - 1. The TODAY Study Group, A clinical trial to maintain glycemic control in youth with type 2 diabetes. N Engl J Med, 2012. 366(24): p. 2247-56. - 2. Kahn, S.E., R.L. Hull, and K.M. Utzschneider, Mechanisms linking obesity to insulin resistance and type 2 diabetes. Nature, 2006. 444(7121): p. 840-8...	[]
NCT01846611	R279741	(trabectedin)	R279741 (trabectedin) \ YONDELIS, ET-743 (trabectedin), is being co-developed by Janssen Research & Development, LLC pursuant to a licensing arrangement with Pharma Mar, S.A. Janssen Research & Development is a global organization that operates through different legal entities in various countries. Therefore, the legal...	[ "Confidentiality Statement", "LIST OF IN-TEXT TABLES AND FIGURES", "TABLES", "PROTOCOL AMENDMENTS", "Amendment 6 (9 January 2018)", "Amendment INT-5 (18 March 2016)", "Applicable Section(s) Description of Change(s)", "Amendment INT-4 (17 December 2015)", "Amendment INT-3 (26 August 2015)", "Amendm...
NCT01868477	1	Background	1 Background	[]
NCT01868477	1.1	Overview of disease pathogenesis, epidemiology and current treatment	1.1 Overview of disease pathogenesis, epidemiology and current treatment Overview The myelodysplastic syndromes (MDS) include a diverse group of acquired disorders of hematopoeisis, collectively characterized by bone marrow failure (ie, inadequate production of healthy, mature blood cells) and a tendency for clonal ev...	[ "Overview", "Classification", "Treatment", "Iron overload in MDS" ]
NCT01868477	1.2	Introduction to investigational treatment(s) and other study treatment(s)	1.2 Introduction to investigational treatment(s) and other study treatment(s)	[]
NCT01868477	1.2.1	Overview of Deferasirox (ICL670)	1.2.1 Overview of Deferasirox (ICL670) Deferasirox (DFX) (company research code: ICL670) is an orally active chelator that is highly selective for iron (III). It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio. Two molecules of DFX form a complete complex with Fe3+. The high potency of DFX in m...	[]
NCT01868477	1.2.1.1	Non-clinical experience	1.2.1.1 Non-clinical experience Preclinical studies revealed that DFX did not affect fertility and it is neither teratogenic nor carcinogenic. Detailed information on preclinical evaluation of DFX is provided in the current [Investigators' Brochure]. In addition to serum ferritin levels also reactive oxygen species (RO...	[]
NCT01868477	1.2.1.2	Clinical experience	1.2.1.2 Clinical experience Clinical studies have shown DFX to effectively chelate iron in patients with transfusional iron overload as demonstrated by decreases in LIC, SF and cardiac iron (MRI T2\) in patients with various underlying anemia [\(Nick 2003, Cappellini 2006, Vichinsky 2007, Porter 2008, Pennell 2010\)](#...	[]
NCT01868477	1.2.2	Overview of EPO	1.2.2 Overview of EPO The process of erythropoiesis in the bone marrow takes 14–17 days and is highly dependent on a number of hemopoietic growth factors. Erythropoietin (EPO) alone, or in combination with other colony-stimulating factors (CSFs), has therefore been investigated as a potential approach to correct the an...	[]
NCT01868477	2	Rationale	2 Rationale	[]
NCT01868477	2.1	Study rationale and purpose	2.1 Study rationale and purpose Treatment goals for patients with lower risk MDS primarily involve managing anemia and cytopenias. While specific therapies and the use of growth factors stimulating erythropoiesis may alleviate transfusion requirements in some patients, 60-80% of patients do not respond and require ongo...	[]
NCT01868477	2.2	Rationale for the study design	2.2 Rationale for the study design This is an open-label, phase II, randomized, pilot study. Although, DFX and EPO have been administered concomitantly in some studies (EPIC, US22) this was not part of the study design and the combination was not analyzed. In addition, there are no published studies of the combination ...	[]
NCT01868477	2.3	Rationale for dose and regimen selection	2.3 Rationale for dose and regimen selection EPO treatment is used in MDS patients early after the diagnosis to induce erythroid response and alleviate the symptoms of anemia. At this stage, iron overload is not expected to be high. In addition, the mechanism by which DFX might be efficacious in this setting is related...	[]
NCT01868477	2.4	Rationale for choice of combination drugs	2.4 Rationale for choice of combination drugs Anecdotal case reports and clinical trials suggest that MDS patients can show improvement in hematopoietic function if they receive iron chelation therapy with DFX. In an ad hoc analysis, erythroid response rate during DFX treatment was 22% in 341 MDS patients included in t...	[]
NCT01868477	3	Objectives and endpoints	3 Objectives and endpoints Objectives and related endpoints are described in [Table 3-1](#page-48-0) below. Table 3-1 Objectives and related endpoints \| Objective \| Endpoint \| Analysis \| \|------------------------------------------------------------------------------------------------------------------------------------...	[]
NCT01868477	4	Study design	4 Study design	[]
NCT01868477	4.1	Description of study design	4.1 Description of study design This is an open-label, phase II, randomized, multi-center, pilot study to assess the efficacy in term of erythroid improvement of DFX combined with EPO compared to EPO alone in patients with low- and int-1-risk MDS. Patients will be randomly assigned to DFX plus EPO 40,000 units/week or ...	[ "Pre-treatment phase (Screening)", "Treatment phase" ]
NCT01868477	30	day follow-up	30 day follow-up Patients who discontinue study drug before completing the study should be scheduled for a visit as soon as possible, at which time all of the assessments listed for the final visit will be performed. At a minimum, all patients who discontinue study treatment, including those who refuse to return for a ...	[ "4.2 Definition of end of the study", "4.3 Early study termination", "5 Population", "5.1 Patient population", "5.2 Inclusion criteria", "ALLOWED PRIOR CONCURRENT THERAPY:", "5.3 Exclusion criteria", "6 Treatment", "6.1 Study treatment", "6.1.1 Dosing regimen", "Deferasirox DT (10 mg/kg/day, Exj...
NCT01940887	A	PHASE 3 RANDOMIZED, DOUBLE-MASKED, CONTROLLED TRIAL TO ESTABLISH THE SAFETY AND EFFICACY OF INTRAVITREOUS ADMINISTRATION OF FOVISTATM (ANTI PDGF-B PEGYLATED APTAMER) ADMINISTERED IN COMBINATION WITH EITHER AVASTIN® OR EYLEA® COMPARED TO AVASTIN® OR EYLEA® MONOTHERAPY IN SUBJECTS WITH SUBFOVEAL NEOVASCULAR AGE-RELATED M...	A PHASE 3 RANDOMIZED, DOUBLE-MASKED, CONTROLLED TRIAL TO ESTABLISH THE SAFETY AND EFFICACY OF INTRAVITREOUS ADMINISTRATION OF FOVISTATM (ANTI PDGF-B PEGYLATED APTAMER) ADMINISTERED IN COMBINATION WITH EITHER AVASTIN® OR EYLEA® COMPARED TO AVASTIN® OR EYLEA® MONOTHERAPY IN SUBJECTS WITH SUBFOVEAL NEOVASCULAR AGE-RELATED...	[ "SPONSOR: OPHTHOTECH CORP.", "FOR MEDICAL EMERGENCIES REFER TO THE \"SAFETY CONTACT LIST\" PROVIDED SEPARATELY", "1 GLOSSARY OF ABBREVIATIONS", "2 SUMMARY OF PROTOCOL OPH1004B", "3 STUDY ASSESSMENTS", "Year 1", "STUDY ASSESSMENTS (CONTINUED)", "Year 2", "4 INTRODUCTION", "4.1 Age-Related Macular D...
NCT01940887	S	11 STATISTICAL METHOD	S 11 STATISTICAL METHOD 11.1 Experimental Design Subjects will be randomized in a 1:1 ratio to the following dose groups: - Fovista™ 1.5 mg/eye + Avastin® 1.25 mg/eye or Eylea® 2 mg/eye - Fovista™ sham + Avastin® 1.25 mg/eye or Eylea® 2 mg/eye Within each of the above dose groups, subjects will be randomized in a 1:1 ...	[ "11.1 Experimental Design", "11.2 Endpoints", "11.2.1 Primary Efficacy Endpoint", "11.2.2 Secondary Efficacy Endpoints", ".2.3 Safety and Tolerability Endpoints 11", "11.3 Number of Subjects", "11.3.1 Sample Size Required", "11.4 Randomization Procedure", "11.5 Masking Procedures", "11.5.1 Visual ...
NCT01970982	1	INSTITUTIONAL REVIEW BOARD (IRB) APPROVAL	1 INSTITUTIONAL REVIEW BOARD (IRB) APPROVAL	[]
NCT01970982	1.1	Institutional Review Board (IRB) Approval	1.1 Institutional Review Board (IRB) Approval Prior to the start of the study, the clinical study protocol, together with its associated documents (informed consent form [ICF] including both subject information sheet and consent form, subject recruitment procedures [e.g. advertisements], written information to be provi...	[]
NCT01970982	1.2	Ethical Conduct of the Study	1.2 Ethical Conduct of the Study The study will be performed in accordance with ethical principles that have their origin in the [Declaration of Helsinki, 2008](#page-145-0) and are consistent with ICH/GCP, Ethical Guidelines for Clinical Studies (Ministry of Health, Labour and Welfare, 2003 [as last amended on July 31...	[]
NCT01970982	1.3	Subject Information and Consent	1.3 Subject Information and Consent	[]
NCT01970982	1.3.1	Study Consent/Subject Information Sheet for Participation to the Study	1.3.1 Study Consent/Subject Information Sheet for Participation to the Study Confidentiality statement: Data and information contained in this document are considered to constitute trade Before or at the Screening Visit, the Investigator will ensure each subject is given full and adequate oral and written information a...	[]
NCT01970982	1.3.2	Informed Consent Form/Subject Information Sheet for Long -term Bio-Banking	1.3.2 Informed Consent Form/Subject Information Sheet for Long -term Bio-Banking In addition to the ICF for the participation in the study, each subject will be asked for consent to the additional bio-banking for measurements of BoExp and risk markers in serum/plasma and urine and for consent to the additional bio-bank...	[]
NCT01970982	1.3.2.1	Bio-banking for Biomarkers of Exposure and Risk Markers	1.3.2.1 Bio-banking for Biomarkers of Exposure and Risk Markers Subjects will be provided with a separate subject information sheet and will be asked for their consent for samples (serum/plasma/urine) that will be stored in a bio-bank for subsequent analysis of biomarkers of exposure (BoExp) and/or risk markers followi...	[]
NCT01970982	1.3.2.2	Bio-banking for Transcriptomics (Pharmacogenomics)	1.3.2.2 Bio-banking for Transcriptomics (Pharmacogenomics) Confidentiality statement: Data and information contained in this document are considered to constitute trade secrets and confidential commercial information, and the legal protections provided to such trade secrets and confidential information are hereby claim...	[]
NCT01970982	1.3.2.3	Information on Optional Consents to Bio-banking	1.3.2.3 Information on Optional Consents to Bio-banking Each subject will be given full and adequate oral and written information about the nature, purpose, possible risks and benefits of bio-banking, and the Investigator will answer all questions the subject might have to his/her full satisfaction. The subject will be...	[]
NCT01970982	1.3.3	Amendment to the Informed Consent Forms	1.3.3 Amendment to the Informed Consent Forms If a protocol amendment is required, or if new information regarding the risk profile of the Investigational Product (IP) becomes available, an amendment may be required to the ICFs. If revision of the ICFs is necessary, the Principal Investigator will, with the support of ...	[]
NCT01970982	1.4	Good Clinical Practice and Regulatory Requirements	1.4 Good Clinical Practice and Regulatory Requirements The procedures set out in this clinical study protocol pertaining to the conduct, evaluation, and documentation of this study are designed to ensure that the Sponsor, its authorized representative, and Principal Investigator abide by the principles of the ICH guide...	[]
NCT01970982	2	INTRODUCTION	2 INTRODUCTION	[]
NCT01970982	2.1	Background	2.1 Background	[]
NCT01970982	2.1.1	Smoking-Related Diseases and Harm Reduction Strategy	2.1.1 Smoking-Related Diseases and Harm Reduction Strategy Cigarette smoking causes pulmonary and cardiovascular diseases and other serious diseases in smokers [\(U.S. Department of Health and Human Services, 2010\)](#page-152-0). The effects of smoking and smoking cessation on mortality from cardiovascular disease amo...	[]
NCT01970982	2.1.2	Description of the Product and Scientific Findings	2.1.2 Description of the Product and Scientific Findings Thousands of chemicals - "smoke constituents" - are formed when tobacco is burned or combusted. More than 5,300 smoke constituents have been identified [\(Rodgman and Perfetti,](#page-152-1) [2009\)](#page-152-1), and more than 100 of them have been categorized a...	[]
NCT01970982	2.2	Purpose of the Study	2.2 Purpose of the Study The overall goal of the study is to show that the ad libitum use of THS 2.2 for 5 days by adult healthy Japanese smokers results in a reduction in selected BoExp to HPHCs (except BoExp to nicotine) in a well-controlled environment and to obtain information about safety in subjects using the THS...	[]
NCT01970982	2.3	Anticipated Benefits and Risks	2.3 Anticipated Benefits and Risks	[]
NCT01970982	2.3.1	Anticipated Benefits	2.3.1 Anticipated Benefits In Japan, research conducted by the Ministry of Health, Labour and Welfare has shown that 35.9% of male and 43.6% of female respondents over 20 years of age expressed the wish to quit smoking [\(International Tobacco Online, 2012\)](#page-148-1). In a large follow-up study of middle aged Japa...	[]
NCT01970982	2.3.2	Anticipated Foreseeable Risks due to Study Procedures	2.3.2 Anticipated Foreseeable Risks due to Study Procedures - Risks related to blood sampling, e.g. excessive bleeding, fainting, hematoma, paresthesia, or infection. - Risks related to chest X-rays, e.g. a small increase of risk to develop cancer later in life. - Risks related to drug application as part of testing pr...	[]
NCT01970982	2.3.3	Anticipated Foreseeable Risks due to Investigational Product (THS 2.2/CC)	2.3.3 Anticipated Foreseeable Risks due to Investigational Product (THS 2.2/CC) • Change in smoking habits due to study requirements and related concomitant symptoms, (e.g., craving, withdrawal symptoms). All risks related to study procedures, IP, or support for smoking abstinence will be explained in detail to the sub...	[]
NCT01970982	2.3.4	Unforeseeable Risks	2.3.4 Unforeseeable Risks As with any new IP, there may be unforeseeable risks and hazards that could occur. The possibility of such will be explained at Screening and at Admission. Mitigation will include close monitoring and medical supervision to detect any unforeseeable risk or safety signals at the earliest possib...	[]
NCT01970982	3	STUDY OBJECTIVES	3 STUDY OBJECTIVES	[]
NCT01970982	3.1	Primary Objective	3.1 Primary Objective The primary objective of this study is: • To demonstrate the reduction of primary biomarkers of exposure (BoExp) in smokers switching from conventional cigarettes (CC) to THS 2.2 as compared to smokers continuing to smoke CC.	[]
NCT01970982	3.2	Secondary Objectives	3.2 Secondary Objectives The secondary objectives of this study are: - To determine the reduction of secondary BoExp on Day 5 in smokers switching from CC to THS 2.2 as compared to smokers continuing to smoke CC. - To describe the levels of primary and secondary BoExp over the exposure period in smokers switching from ...	[]
NCT01970982	3.3	Exploratory Objectives	3.3 Exploratory Objectives The exploratory objectives of this study are: - To describe the following parameters in smokers switching from CC to THS 2.2 as compared to smokers continuing to smoke CC and smokers switching from CC to SA: - Excretion of mutagenic material in urine. - Subjective effects of smoking. - CYP2A6...	[]
NCT01970982	3.4	Study Endpoints	3.4 Study Endpoints The primary and secondary BoExp measured in this study are presented in Table S1. Table S1: \| \| Biomarkers of Exposure (BoExp) \| HPHCs \| Matrix \| \|-----------------\|------------------------------------------------\|----------------------\|-------------------\| \| \| monohydroxybutenyl mercapturic acid(MH...	[]
NCT01970982	3.4.1	Primary Endpoints	3.4.1 Primary Endpoints - To demonstrate the reduction of primary BoExp in smokers switching from CC to THS 2.2 as compared to those continuing to smoke CC. - MHBMA, 3-HPMA, S-PMA (concentration adjusted to creatinine) in 24-hour urine, and COHb in blood (expressed as % saturation of hemoglobin) as measured on Day 5. E...	[]
NCT01970982	3.4.2	Secondary Endpoints	3.4.2 Secondary Endpoints - To determine the reduction of secondary BoExp on Day 5 in smokers switching from CC to THS 2.2 as compared to smokers continuing to smoke CC. - BoExp listed as secondary (Table S1) for the comparison of levels between smokers switching from CC to THS 2.2 and smokers continuing to smoke CC as...	[]
NCT01970982	3.4.3	Exploratory Endpoints	3.4.3 Exploratory Endpoints - To describe the following parameters in smokers switching from CC to THS 2.2 as compared to smokers continuing to smoke CC and to smokers switching from CC to SA: - Excretion of mutagenic material in urine: Ames Mutagenicity test (YG1024+S9) on Day 5 in 24-hour urine. - Subjective effects ...	[]
NCT01970982	4	INVESTIGATIONAL PLAN	4 INVESTIGATIONAL PLAN	[]
NCT01970982	4.1	Overall Study Design and Plan	4.1 Overall Study Design and Plan A randomized, controlled, open-label, 3-arm, parallel group, single-center study with a stratified randomization by sex and average daily cigarette consumption over the last 4 weeks as reported during the Screening Visit (smokers smoking 10 to 19 CC and smokers smoking >19 CC per day)....	[]
NCT01970982	4.2	Rationale for Study Design and Control Groups	4.2 Rationale for Study Design and Control Groups The minimum age of 23 years age in the inclusion criteria was selected based on: - The legal age of smoking in Japan is 20 years. - To account for the 3 years of smoking history. This clinical study aims to demonstrate reduction in exposure to selected HPHCs (except nic...	[]
NCT01970982	4.3	Appropriateness of Measurements	4.3 Appropriateness of Measurements The laboratory measures to be utilized in this study were selected based on the following criteria: 1) the availability of a validated analytical method, and 2) measure is known to be directly or indirectly affected by smoking; 3) measure is readily reversible after smoking cessation...	[]
NCT01970982	4.4	Study Duration	4.4 Study Duration The entire study duration per subject will be 17 to 44 days, including a Screening period of up to 28 days prior to baseline (Day -30 to Day -3), an 9-day confinement period (afternoon of Day -2 to time of Discharge at Day 6), followed by a 7-day safety follow-up period (until Day 13) for the recordi...	[]
NCT01970982	5	STUDY POPULATION	5 STUDY POPULATION	[]
NCT01970982	5.1	Selection of Study Population	5.1 Selection of Study Population In total, 160 female or male smoking, healthy Japanese subjects who smoke per day at least 10 non-menthol CC for the last 4 weeks with a maximum yield of 1 mg nicotine ISO per cigarette will be included in this study. The maximum number of CC is not limited. Subjects must have a smokin...	[]
NCT01970982	5.1.1	Inclusion Criteria	5.1.1 Inclusion Criteria At the Screening Visit/day of Admission, each subject must meet the following criteria: \| \| 1.Inclusion Criteria \| Rationale \| Screening \| Day ofAdmission(Day -2) \| \|----\|----------------------------------------------------------------------------------------------------------------------------...	[]
NCT01970982	5.1.2	Exclusion Criteria	5.1.2 Exclusion Criteria Subjects who meet any of the following exclusion criteria must not be enrolled into the study: ZRHR-REXC-04-JP Clinical Study Protocol Confidential Final 2.0/08 July 2013 Page 53 of 171 \| Exclusion Criteria \| Rationale \| Screening \| Day ofAdmission(Day -2) \| \|-----------------------------------...	[]

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