protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT02736409 | 6.2.3 | Dosing | 6.2.3 Dosing During the 4-week screening period, all subjects will receive 10 mL of blinded investigational product twice daily based on treatment assignment in SHP621-301. During the 36-week double-blind treatment period, oral administration of 10 mL of investigational product will occur twice daily (qAM, pc, and hs),... | [] |
NCT02736409 | 6.2.4 | Unblinding the Treatment Assignment | 6.2.4 Unblinding the Treatment Assignment The treatment assignment must not be broken during the study except in emergency situations where the identification of the investigational product is required for further treatment of the subject. The investigator should contact the medical monitor and the sponsor as soon as p... | [] |
NCT02736409 | 6.3 | Labeling, Packaging, Storage, and Handling | 6.3 Labeling, Packaging, Storage, and Handling | [] |
NCT02736409 | 6.3.1 | Labeling | 6.3.1 Labeling Labels containing study information and pack identification are applied to the investigational product(s) container. All investigational product is labeled with a minimum of the protocol number, Med ID, dosage form (including product name and quantity in pack), directions for use, storage conditions, exp... | [] |
NCT02736409 | 6.3.2 | Packaging | 6.3.2 Packaging Investigational product is packaged in the following labeled containers: The sponsor will supply the following medication to the study sites in a blinded manner: OBS 0.2 mg/mL or placebo in an 8 ounce amber glass bottle for multiple use. Bottles of OBS 0.2 mg/mL or placebo will be packaged in an appropr... | [] |
NCT02736409 | 6.3.3 | Storages | 6.3.3 Storages The investigator has overall responsibility for ensuring that investigational product is stored in a secure, limited-access location. Limited responsibility may be delegated to the pharmacy or member of the study team, but this delegation must be documented. OBS and placebo must be refrigerated at 2-8ºC ... | [] |
NCT02736409 | 6.3.4 | Special Handling | 6.3.4 Special Handling The investigational product should be stored under refrigeration at 2-8°C/36-46°F at all times. The investigational product should be protected from light and shaken well immediately prior to each dose. | [] |
NCT02736409 | 6.4 | Drug Accountability | 6.4 Drug Accountability Investigators will be provided with sufficient amounts of the investigational product to carry out this protocol for the agreed-upon number of subjects. The investigator or designee will acknowledge receipt of the investigational product, documenting shipment content and condition. Accurate reco... | [] |
NCT02736409 | 6.5 | Subject Compliance | 6.5 Subject Compliance Compliance with investigational product will be assessed at each study visit. Subjects must be instructed to bring their unused investigational product and empty/used investigational product packaging to every visit. Drug accountability must be assessed at the container/packaging level for unused... | [] |
NCT02736409 | 7 | STUDY PROCEDURES | 7. STUDY PROCEDURES | [] |
NCT02736409 | 7.1 | Study Schedule | 7.1 Study Schedule The detailed study procedures/assessments to be performed throughout the study are outlined in the Schedule of Assessments (Table 1-1) and must be referred to in conjunction with the instructions provided in this section. Prior to performing any study-related procedures (including those related to sc... | [] |
NCT02736409 | 7.1.1 | Screening Period (Weeks -4 to 0) | 7.1.1 Screening Period (Weeks -4 to 0) The screening period starts when subjects sign informed consent. The screening period will comprise up to 4 weeks, during which all procedures listed for the screening visit (Visit 0) in Table 1-1 shall be completed. The screening period will allow for the determination of eligibi... | [] |
NCT02736409 | 7.1.1.1 | Screening Visit (Visit 0) / Visit 4 of SHP621-301 Study | 7.1.1.1 Screening Visit (Visit 0) / Visit 4 of SHP621-301 Study The screening visit (Visit 0) assessments and procedures, beginning with informed consent, will be performed as outlined in Table 1-1. The following procedures will be performed at the screening visit: - Obtain subject consent (or assent as applicable for ... | [] |
NCT02736409 | 7.1.2 | Double-blind Treatment Period (Visits 1-8): Weeks 0, 4, 8, 12, 16, 20, 28 and 36 (or Early Termination) | 7.1.2 Double-blind Treatment Period (Visits 1-8): Weeks 0, 4, 8, 12, 16, 20, 28 and 36 (or Early Termination) The double-blind treatment period will comprise 36 weeks, during which all assessments and procedures listed for Visits 1-8 in Table 1-1 shall be completed. During this period, a 3-day visit window will be perm... | [] |
NCT02736409 | 7.1.2.1 | Randomization Visit (Visit 1): Week 0 | 7.1.2.1 Randomization Visit (Visit 1): Week 0 Subjects will return to the site for the randomization visit (Visit 1) to confirm eligibility. The randomization visit (Visit 1) assessments and procedures will be performed as outlined in Table 1-1. The following procedures should be performed first: - Reassess eligibility... | [] |
NCT02736409 | 7.1.2.2 | Visits 2 and 3 (Weeks 4 and 8) | 7.1.2.2 Visits 2 and 3 (Weeks 4 and 8) Subjects will return to the site for Visit 2 (Week 4) and Visit 3 (Week 8). Assessments at these visits will be performed as outlined in Table 1-1. The following procedures should be performed first: - Record vital signs (including blood pressure [systolic and diastolic], heart ra... | [] |
NCT02736409 | 7.1.2.3 | Visit 4 (Week 12) | 7.1.2.3 Visit 4 (Week 12) Subjects will return to the site for Visit 4 (Week 12). Assessments at this visit will be performed as outlined in Table 1-1. The following order is recommended for the procedures that will be performed at this visit: - Record vital signs (including blood pressure [systolic and diastolic], hea... | [] |
NCT02736409 | 7.1.2.4 | Visits 5, 6, and 7 (Weeks 16, 20, and 28) | 7.1.2.4 Visits 5, 6, and 7 (Weeks 16, 20, and 28) Subjects will return to the site for Visits 5, 6, and 7 (Weeks 16, 20, and 28). Assessments at these visits will be performed as outlined in Table 1-1. - Record vital signs (including blood pressure [systolic and diastolic], heart rate, respirations, and temperature) an... | [] |
NCT02736409 | 7.1.2.5 | Visit 8 (Week 36) or Early Termination | 7.1.2.5 Visit 8 (Week 36) or Early Termination Subjects will return to the site for Visit 8 (Week 36). Assessments at this visit will be performed as outlined in Table 1-1. If a subject discontinues prematurely, the assessments for Visit 8 are to be performed as completely as possible. The following procedures should b... | [] |
NCT02736409 | 7.1.3 | Follow-up Period | 7.1.3 Follow-up Period The follow-up period for this protocol is 4 weeks from the last dose of investigational product. Subjects will receive a follow-up phone call at Visit 9 (Week 40) to query for SAEs, AEs, and concomitant treatments (Section [7.1.3.1\)](#page-61-0). | [] |
NCT02736409 | 7.1.3.1 | Safety Follow-up Contact (Visit 9): Week 40 | 7.1.3.1 Safety Follow-up Contact (Visit 9): Week 40 Assessments at this time, as outlined in Table 1-1, will include the following: - Review concomitant medications and procedures. - Perform AE assessments, including specific assessments for signs of glucocorticoid excess. Any AE that occurs during this visit will be r... | [] |
NCT02736409 | 7.2 | Study Evaluations and Procedures | 7.2 Study Evaluations and Procedures The full title and details about who completes the scales used in this study is included in Appendix 1. All assessments listed below will be performed by the subject and/or a qualified/trained site staff as indicated in the assessment description. For subject-completed assessments, ... | [] |
NCT02736409 | 7.2.1 | Efficacy | 7.2.1 Efficacy | [] |
NCT02736409 | 7.2.1.1 | Esophagogastroduodenoscopy with Esophageal Biopsy and Histopathologic Evaluation | 7.2.1.1 Esophagogastroduodenoscopy with Esophageal Biopsy and Histopathologic Evaluation The EGD with endoscopy score and biopsy will be performed during the study as outlined in Table 1-1. The screening EGD with biopsies will be performed by a physician at the investigative site at the final treatment evaluation visit... | [] |
NCT02736409 | 7.2.1.2 | Dysphagia Symptom Questionnaire | 7.2.1.2 Dysphagia Symptom Questionnaire Subjects' dysphagia symptoms will be evaluated using a DSQ ePRO device (Appendix 2). The questionnaire will be completed by subjects daily during the screening period and during the 36-week treatment period. Each evening before bedtime, subjects will be asked to indicate if they ... | [] |
NCT02736409 | 7.2.2 | Safety | 7.2.2 Safety The name and address of each third-party vendor (eg, clinical laboratory) used in this study will be maintained in the investigator's and sponsor's files. | [] |
NCT02736409 | 7.2.2.1 | Medical and Medication History | 7.2.2.1 Medical and Medication History
Medical History The investigator must record all new clinically or medically relevant information which arose after the recording of the medical history in the antecedent study. New medical history will be collected at the screening visit (Visit 0) of this study. Medical history ... | [
"Medical History",
"Medication History"
] |
NCT02736409 | 7.2.2.2 | Physical Examination (Including Height and Weight) | 7.2.2.2 Physical Examination (Including Height and Weight) Abnormalities identified at the screening visit (Visit 0) will be documented in the subject's source documents and on the medical history CRF. Changes after the screening visit (Visit 0) will be captured as AEs on the AE CRF page, as deemed by the investigator.... | [] |
NCT02736409 | 7.2.2.3 | Adverse Event Collection | 7.2.2.3 Adverse Event Collection At each study visit, subjects will be questioned in a general way to ascertain if AEs have occurred since the previous visit (eg, "Have you had any health problems since your last visit?"). AEs are collected from the time informed consent is signed. (Please refer to Section 8.) Any AE t... | [] |
NCT02736409 | 7.2.2.4 | Vital Signs | 7.2.2.4 Vital Signs Vital signs will be conducted after the subject has been supine for at least 5 minutes immediately prior to the assessment and will include blood pressure (systolic and diastolic), heart rate, respirations, and temperature. Blood pressure should be determined by cuff (using the same method, the same... | [] |
NCT02736409 | 7.2.2.5 | Clinical Laboratory Evaluations | 7.2.2.5 Clinical Laboratory Evaluations All clinical laboratory assays will be performed according to the laboratory's normal procedures. All subjects must fast overnight prior to collection of clinical laboratory tests. Reference ranges are to be supplied by the laboratory and will be used to assess the clinical labor... | [
"Biochemistry",
"Hematology",
"Urinalysis",
"Other tests"
] |
NCT02736409 | 7.2.2.6 | Pregnancy Test | 7.2.2.6 Pregnancy Test A serum β-hCG pregnancy test is performed on all female subjects at the screening visit (Visit 0) and the final treatment evaluation visit (Visit 8) or ET visit. A urine pregnancy test is performed on all female subjects at all other visits or if pregnancy is suspected. | [] |
NCT02736409 | 7.2.2.7 | Dual-energy X-ray Absorptiometry for Bone Mineral Density | 7.2.2.7 Dual-energy X-ray Absorptiometry for Bone Mineral Density Dual-energy X-ray absorptiometry (also referred to as DEXA) scans for determination of BMD and body composition measurements will be performed in subjects aged 11-17 years, inclusive, as outlined in Table 1-1. The sites for DXA measurement will be the lu... | [] |
NCT02736409 | 7.2.3 | Other Assessments | 7.2.3 Other Assessments   | [] |
NCT02736409 | 7.2.4 | Volume of Blood to Be Drawn from Each Subject | 7.2.4 Volume of Blood to Be Drawn from Each Subject | Table 7-1: | Approximate Volume of Blood to Be Drawn from Each Subject | | | | |------------|-----------------------------------------------------------|-----------------------|----------------------|----------------------------------| | Assessment | | Sample Volume... | [] |
NCT02736409 | 8 | ADVERSE AND SERIOUS ADVERSE EVENTS ASSESSMENT | 8. ADVERSE AND SERIOUS ADVERSE EVENTS ASSESSMENT | [] |
NCT02736409 | 8.1 | Definition of Adverse Events, Period of Observation, Recording of Adverse Events | 8.1 Definition of Adverse Events, Period of Observation, Recording of Adverse Events An AE is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and... | [] |
NCT02736409 | 8.1.1 | Severity Categorization | 8.1.1 Severity Categorization The severity of AEs must be recorded during the course of the event including the start and stop dates for each change in severity. An event that changes in severity should be captured as a new event. Worsening of pretreatment events, after initiation of investigational product, must be re... | [] |
NCT02736409 | 8.1.2 | Relationship Categorization | 8.1.2 Relationship Categorization | Mild: | A type of AE that is usually transient and may require only minimal treatmentor therapeutic intervention. The event does not generally interfere with usuallactivities of daily living. | |-----------------------------|-----------------------------------------------------------... | [] |
NCT02736409 | 8.1.3 | Outcome Categorization | 8.1.3 Outcome Categorization The outcome of AEs must be recorded during the course of the study on the CRF. Outcomes are as follows: - Fatal - Not Recovered/Not Resolved - Recovered/Resolved - Recovered/Resolved With Sequelae - Recovering/Resolving - Unknown | [] |
NCT02736409 | 8.1.4 | Symptoms of the Disease under Study | 8.1.4 Symptoms of the Disease under Study Symptoms of the disease under study should not be classed as AEs as long as they are within the normal day-to-day fluctuation or expected progression of the disease and are part of the efficacy data to be collected in the study; however, significant worsening of the symptoms sh... | [] |
NCT02736409 | 8.1.5 | Clinical Laboratory and Other Safety Evaluations | 8.1.5 Clinical Laboratory and Other Safety Evaluations A change in the value of a clinical laboratory or vital sign assessment can represent an AE if the change is clinically relevant or if, during treatment with the investigational product, a shift of a parameter is observed from a normal value to an abnormal value, o... | [] |
NCT02736409 | 8.1.6 | Pregnancy | 8.1.6 Pregnancy All pregnancies are to be reported from the time informed consent is signed until the defined follow-up period stated in Section 7.1.3. Any report of pregnancy for any female study participant must be reported within 24 hours to the Shire Global Pharmacovigilance and Risk Management Department using the... | [] |
NCT02736409 | 8.1.7 | Abuse, Misuse, Overdose, and Medication Error | 8.1.7 Abuse, Misuse, Overdose, and Medication Error Abuse, misuse, overdose, or medication error (as defined below) must be reported to the sponsor according to the SAE reporting procedure whether or not they result in an AE/SAE as described in Section 8.2. Note: The 24-hour reporting requirement for SAEs does not appl... | [] |
NCT02736409 | 8.2 | Serious Adverse Event Procedures | 8.2 Serious Adverse Event Procedures | [] |
NCT02736409 | 8.2.1 | Reference Safety Information | 8.2.1 Reference Safety Information The reference for safety information for this study is the investigator brochure, which the sponsor has provided under separate cover to all investigators. | [] |
NCT02736409 | 8.2.2 | Reporting Procedures | 8.2.2 Reporting Procedures All initial and follow-up SAE reports must be reported by the investigator to the Shire Global Pharmacovigilance and Risk Management Department and the CRO medical monitor within 24 hours of the first awareness of the event. Note: The 24-hour reporting requirement for SAEs does not apply to r... | [] |
NCT02736409 | 8.2.3 | Serious Adverse Event Definition | 8.2.3 Serious Adverse Event Definition A Serious Adverse Event (SAE) is any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: - Results in death - Is life-threatening. Note: The term "life-threatening" in the definition of "serious" refers to an event in ... | [] |
NCT02736409 | 8.2.4 | Serious Adverse Event Collection Time Frame | 8.2.4 Serious Adverse Event Collection Time Frame All SAEs (regardless of relationship to study) are collected from the time the subject signs the informed consent until the defined follow-up period stated in Section 7.1.3 and must be reported to the Shire Global Pharmacovigilance and Risk Management Department and the... | [] |
NCT02736409 | 8.2.5 | Serious Adverse Event Onset and Resolution Dates | 8.2.5 Serious Adverse Event Onset and Resolution Dates The onset date of the SAE is defined as the date the event meets serious criteria. The resolution date is the date the event no longer meets serious criteria, the date the symptoms resolve, or the event is considered chronic. In the case of hospitalizations, the ho... | [] |
NCT02736409 | 8.2.6 | Fatal Outcome | 8.2.6 Fatal Outcome Any SAE that results in the subject's death (ie, the SAE was noted as the primary cause of death) must have "fatal" checked as an outcome with the date of death recorded as the resolution date. For all other events ongoing at the time of death that did not contribute to the subject's death, the outc... | [] |
NCT02736409 | 8.2.7 | Regulatory Agency, Institutional Review Board, Ethics Committee, and Site Reporting | 8.2.7 Regulatory Agency, Institutional Review Board, Ethics Committee, and Site Reporting The sponsor and the clinical CRO are responsible for notifying the relevant regulatory authorities/US central Institutional Review Boards (IRBs) of related, unexpected SAEs. In addition, the sponsor and the clinical CRO are respon... | [] |
NCT02736409 | 9 | DATA MANAGEMENT AND STATISTICAL METHODS | 9. DATA MANAGEMENT AND STATISTICAL METHODS | [] |
NCT02736409 | 9.1 | Data Collection | 9.1 Data Collection The investigators' authorized site personnel must enter the information required by the protocol on the CRF. A study monitor will visit each site in accordance with the monitoring plan and review the CRF data against the source data for completeness and accuracy. Discrepancies between source data an... | [] |
NCT02736409 | 9.2 | Clinical Data Management | 9.2 Clinical Data Management Data are to be entered into a clinical database as specified in the CRO's data management plan. Quality control and data validation procedures are applied to ensure the validity and accuracy of the clinical database. Data are to be reviewed and checked for omissions, errors, and values requ... | [] |
NCT02736409 | 9.3 | Data Handling Considerations | 9.3 Data Handling Considerations Data that may potentially unblind the treatment assignment (ie, investigational product serum concentrations, treatment allocation, and investigational product preparation/accountability data) will be handled with special care during the data cleaning and review process. These data will... | [] |
NCT02736409 | 9.4 | Statistical Analysis Process | 9.4 Statistical Analysis Process The study will be analyzed by the sponsor or its agent. All statistical analyses will be performed using SAS® (SAS Institute, Cary, NC, USA) version 9.3 or higher. The statistical analysis plan (SAP) will provide the statistical methods and definitions for the analysis of the efficacy a... | [] |
NCT02736409 | 9.5 | Planned Interim Analysis, Adaptive Design, and Data Monitoring Committee | 9.5 Planned Interim Analysis, Adaptive Design, and Data Monitoring Committee No interim analysis is planned. | [] |
NCT02736409 | 9.6 | Sample Size Calculation and Power Considerations | 9.6 Sample Size Calculation and Power Considerations Approximately 200 subjects (88%) who are randomized in the SHP621-301 study are estimated to complete the SHP621-301 study and enroll in this treatment extension study based on enrollment observed in the Phase 2 study (MPI 101-06). The primary efficacy measure of the... | [] |
NCT02736409 | 9.7 | Study Population | 9.7 Study Population The safety set will include all subjects who are randomized and receive at least 1 dose of investigational product. The intent-to-treat (ITT) set will include all randomized subjects. Subjects will be analyzed according to their assigned treatment, regardless of the treatment actually received. The... | [] |
NCT02736409 | 9.8 | Efficacy Analyses | 9.8 Efficacy Analyses | [] |
NCT02736409 | 9.8.1 | Primary Efficacy Endpoint | 9.8.1 Primary Efficacy Endpoint The primary efficacy endpoint for each subject is relapse during the double-blind randomized withdrawal period. Relapse, a binary response (either with a relapse or not), is defined as having an eosinophil count of ≥15 eos/HPF from at least 2 of 3 levels of the esophagus, as determined b... | [] |
NCT02736409 | 9.8.2 | Secondary Efficacy Endpoints | 9.8.2 Secondary Efficacy Endpoints | [] |
NCT02736409 | 9.8.2.1 | Key Secondary Efficacy Endpoint | 9.8.2.1 Key Secondary Efficacy Endpoint The key secondary efficacy endpoint is the long-term treatment response, a binary response over an extended period of 36 weeks in adolescent and adult subjects who were randomized to OBS treatment but did not respond after 12 weeks in the SHP621-301 induction study (subject did n... | [] |
NCT02736409 | 9.8.3 | Exploratory Efficacy Endpoints | 9.8.3 Exploratory Efficacy Endpoints The exploratory endpoints that will be explored are the following: | [] |
NCT02736409 | 9.9 | Safety Analyses | 9.9 Safety Analyses Safety data will be presented for the safety set by treatment group. The safety data collected at the randomization visit (Visit 1), or at the screening visit (Visit 0) if not collected at Visit 1, will be used as the baseline value for safety analyses. TEAEs are defined as AEs that start or deterio... | [] |
NCT02736409 | 10 | SPONSOR'S AND INVESTIGATOR'S RESPONSIBILITIES | 10. SPONSOR'S AND INVESTIGATOR'S RESPONSIBILITIES This study is conducted in accordance with current applicable regulations, ICH, EU Directive 2001/20/EC and its updates, and local ethical and legal requirements. The name and address of each third-party vendor (eg, CRO) used in this study will be maintained in the inve... | [] |
NCT02736409 | 10.1 | Sponsor's Responsibilities | 10.1 Sponsor's Responsibilities | [] |
NCT02736409 | 10.1.1 | Good Clinical Practice Compliance | 10.1.1 Good Clinical Practice Compliance The study sponsor and any third party to whom aspects of the study management or monitoring have been delegated will undertake their assigned roles for this study in compliance with all applicable industry regulations, ICH GCP Guideline E6 (1996), EU Directive 2001/20/EC, as wel... | [] |
NCT02736409 | 10.1.2 | Indemnity/Liability and Insurance | 10.1.2 Indemnity/Liability and Insurance The sponsor of this research adheres to the recommendations of the Association of British Pharmaceutical Industry Guidelines. If appropriate, a copy of the indemnity document is supplied to the investigator before study initiation, per local country guidelines. The sponsor ensur... | [] |
NCT02736409 | 10.1.3 | Public Posting of Study Information | 10.1.3 Public Posting of Study Information The sponsor is responsible for posting appropriate study information on applicable websites. Information included in clinical study registries may include participating investigators' names and contact information. | [] |
NCT02736409 | 10.1.4 | Submission of Summary of Clinical Study Report to Competent Authorities of Member States Concerned and Ethics Committees | 10.1.4 Submission of Summary of Clinical Study Report to Competent Authorities of Member States Concerned and Ethics Committees The sponsor will provide a summary of the clinical study report to the competent authority of the member state(s) concerned as required by regulatory requirement(s) and to comply with the comm... | [] |
NCT02736409 | 10.1.5 | Study Suspension, Termination, and Completion | 10.1.5 Study Suspension, Termination, and Completion The sponsor may suspend or terminate the study, or part of the study, at any time for any reason. If the study is suspended or terminated, the sponsor will ensure that applicable sites, regulatory agencies and IRBs/ECs are notified as appropriate. Additionally, the d... | [] |
NCT02736409 | 10.2 | Investigator's Responsibilities | 10.2 Investigator's Responsibilities | [] |
NCT02736409 | 10.2.1 | Good Clinical Practice Compliance | 10.2.1 Good Clinical Practice Compliance The investigator must undertake to perform the study in accordance with ICH GCP Guideline E6 (1996), EU Directive 2001/20/EC, and applicable regulatory requirements and guidelines. It is the investigator's responsibility to ensure that adequate time and appropriately trained res... | [] |
NCT02736409 | 10.2.3 | Documentation and Retention of Records | 10.2.3 Documentation and Retention of Records | [] |
NCT02736409 | 10.2.3.1 | Case Report Forms | 10.2.3.1 Case Report Forms Electronic CRFs are supplied by the CRO and should be handled in accordance with instructions from the sponsor. The investigator is responsible for maintaining adequate and accurate medical records from which accurate information is recorded onto CRFs, which have been designed to record all o... | [] |
NCT02736409 | 10.2.3.2 | Recording, Access, and Retention of Source Data and Study Documents | 10.2.3.2 Recording, Access, and Retention of Source Data and Study Documents Original source data to be reviewed during this study will include but are not limited to subject's medical file, original clinical laboratory reports, and histology and pathology reports. All key data must be recorded in the subject's medical... | [] |
NCT02736409 | 10.2.3.3 | Audit/Inspection | 10.2.3.3 Audit/Inspection To ensure compliance with relevant regulations, data generated by this study must be available for inspection upon request by representatives of, for example, the US FDA (as well as other US national and local regulatory authorities), the EMA, the Medicines and Healthcare products Regulatory A... | [] |
NCT02736409 | 10.2.3.4 | Financial Disclosure | 10.2.3.4 Financial Disclosure The investigator is required to disclose any financial arrangement during the study and for 1 year after, whereby the outcome of the study could be influenced by the value of the compensation for conducting the study, or other payments the investigator received from the sponsor. The follow... | [] |
NCT02736409 | 10.3 | Ethical Considerations | 10.3 Ethical Considerations | [] |
NCT02736409 | 10.3.1 | Informed Consent | 10.3.1 Informed Consent It is the responsibility of the investigator to obtain written informed consent (or assent as applicable for subjects <18 years of age) from all study subjects prior to any study-related procedures including screening assessments. All consent documentation must be in accordance with applicable r... | [] |
NCT02736409 | 10.3.2 | Institutional Review Board or Ethics Committee | 10.3.2 Institutional Review Board or Ethics Committee For sites outside the EU, it is the responsibility of the investigator to submit this protocol, the informed consent document (approved by the sponsor or their designee), relevant supporting information, and all types of subject recruitment information to the IRB/EC... | [] |
NCT02736409 | 10.4 | Privacy and Confidentiality | 10.4 Privacy and Confidentiality All US-based sites and laboratories or entities providing support for this study, must, where applicable, comply with HIPAA of 1996. A site that is not a covered entity as defined by HIPAA must provide documentation of this fact to the CRO/sponsor. The confidentiality of records that ma... | [] |
NCT02736409 | 10.5 | Study Results/Publication Policy | 10.5 Study Results/Publication Policy Shire will endeavor to publish the results of all qualifying, applicable, and covered studies according to external guidelines in a timely manner regardless of whether the outcomes are perceived as positive, neutral, or negative. Additionally, Shire adheres to external guidelines (... | [] |
NCT02736409 | 11 | REFERENCES | 11. REFERENCES Bachrach LK, Sills IN, Section on Endocrinology. Clinical report—bone densitometry in children and adolescents. Pediatrics. 2011;127(1):189-94. Bone Mineral Density in Childhood Study (BMDCS). Available at: http://www.bmdcspublic.com. Accessed August 5, 2015. Dellon ES, Jensen ET, Martin CF, et al. Preva... | [] |
NCT02736409 | 12 | APPENDIX | 12. APPENDIX 
Appendix 1 Scales and Assessments | Full Title of Scale/Assessment | Completed By | |-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------... | [
"Appendix 1 Scales and Assessments",
"Appendix 2 Dysphagia Symptom Questionnaire ePRO for EoE",
"PROTOCOL SIGNATURE PAGE",
"Acknowledgement",
"SUMMARY OF CHANGES FROM PREVIOUS VERSION",
"EMERGENCY CONTACT INFORMATION",
"PRODUCT QUALITY COMPLAINTS",
"LIST OF TABLES",
"LIST OF FIGURES",
"LIST OF APP... |
NCT02736409 | 12 | APPENDIX | 12. APPENDIX 
Appendix 1 Protocol History | Document | Date | Global/Country/Site Specific | |----------------------------------|---------------------------------|---------------------------------| | Protocol Amendment 1 | 22 Jun 2016 | Global | | Original Protocol | 05 Dec 2015 | ylGlobal | |... | [
"Appendix 1 Protocol History",
"Appendix 2 Scales and Assessments",
"Appendix 3 Dysphagia Symptom Questionnaire ePRO for EoE",
"PROTOCOL SIGNATURE PAGE",
"SUMMARY OF CHANGES FROM PREVIOUS VERSION",
"EMERGENCY CONTACT INFORMATION",
"PRODUCT QUALITY COMPLAINTS",
"LIST OF TABLES",
"LIST OF ABBREVIATION... |
NCT02736409 | 12 | APPENDIX | 12. APPENDIX  SHP621-302 19 Dec 2016
Appendix 1 Protocol History | Document | Date | Global/Country/Site Specific | |----------------------|-------------|------------------------------| | Protocol Amendment 2 | 19 Dec 2016 | Global | | Protocol Amendment 1 | 22 Jun 2016 | Global | | Original P... | [
"Appendix 1 Protocol History",
"Appendix 2 Scales and Assessments",
"Appendix 3 Dysphagia Symptom Questionnaire ePRO for EoE",
"For non-commercial use only",
"Rationale for changes:",
"Rationale for changes:"
] |
NCT02839746 | 2 | LIST OF ABBREVIATIONS | 2. LIST OF ABBREVIATIONS | AE | Adverse Event | |------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | AF | Atrial Fibrillation | | ADR | Adverse Drug Reaction | | BI | Boehringer Ingelheim... | [] |
NCT02839746 | 3 | RESPONSIBLE PARTIES | 3. RESPONSIBLE PARTIES | Therapeutic AreaCardiovascularMedicine | | |------------------------------------------------|--| | Team Member Medical Affairs | | | Team Member Epidemiology | | | Trial Clinical Monitor | | | Trial Statistician | | | GPV CTC3.1.1.1 | | | LPVM3.1.1.2 | | | CoordinatorInvestigator | | | [] |
NCT02839746 | 4 | ABSTRACT | 4. ABSTRACT | Name of company: | | Pradaxa® | | | |-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [
"Boehringer Ingelheim Page 10 of 49 Non-interventional Study Protocol BI Study Number 1160.253"
] |
NCT02839746 | 5 | AMENDMENTS AND UPDATES | 5. AMENDMENTS AND UPDATES None. | [] |
NCT02839746 | 6 | MILESTONES | 6. MILESTONES | Milestone | Planned Date | |----------------------------------------|----------------| | Start of data collection | June 2016 | | End of data collection | June2017 | | Registration in theEU PAS register | Not applicable | | Final report of study results: | September 2017 | | [] |
NCT02839746 | 7 | RATIONALE AND BACKGROUND | 7. RATIONALE AND BACKGROUND Pradaxa® (Dabigatran etexilate) is a direct Thrombin inhibitor approved in Europe, USA and many other countries worldwide for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors. Pradaxa® has been studied in the... | [] |
NCT02839746 | 8 | RESEARCH QUESTION AND OBJECTIVES | 8. RESEARCH QUESTION AND OBJECTIVES | [] |
NCT02839746 | 8.1 | RESEARCH QUESTIONS | 8.1 RESEARCH QUESTIONS This non-interventional study will address the following questions: - How do patients with non-valvular atrial fibrillation perceive anticoagulation treatment for stroke prevention (switched from previous treatment to Pradaxa®)? - Is there any geographical variation (between autonomous communitie... | [] |
NCT02839746 | 8.2 | OBJECTIVES: | 8.2 OBJECTIVES:
Primary objective Describe the non-valvular atrial fibrillation patient´s treatment perception by using the PACTQ at three time-points: at baseline, during initiation period and during the continuation period: - - At baseline: when being treated with any anticoagulation therapy to prevent stroke/emboli... | [
"Primary objective",
"Secondary objective"
] |
NCT02839746 | 9 | RESEARCH METHODS | 9. RESEARCH METHODS | [] |
NCT02839746 | 9.1 | STUDY DESIGN | 9.1 STUDY DESIGN This is a non-interventional national, multi-centre study based on newly collected data. The study will enrol consented patients with non-valvular atrial fibrillation in Spain with a VKA therapy and subsequent initiation of Pradaxa® This is an observational study since Pradaxa is prescribed according t... | [] |
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