protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT02704364 | 5.9 | CLINICAL EVALUATIONS | 5.9 CLINICAL EVALUATIONS | [] |
NCT02704364 | 5.9.1 | Colonoscopy | 5.9.1 Colonoscopy Due to the high risk of colonic dysplasia in UC patients with PSC, a 2010 guideline from the AASLD recommends that patients with PSC and IBD undergo surveillance colonoscopy every 1–2 years from the time of diagnosis of PSC (Chapman et al. 2010). Patients with PSC without IBD should undergo surveillan... | [] |
NCT02704364 | 5.9.2 | Magnetic Resonance Cholangiopancreatography | 5.9.2 Magnetic Resonance Cholangiopancreatography MRCP is a noninvasive technique for evaluating the intrahepatic and extrahepatic bile ducts and the pancreatic duct. Unlike conventional ERCP, MRCP does not require contrast material to be administered into the ductal system; thus, the morbidity associated with endoscop... | [] |
NCT02704364 | 5.9.3 | Pharmacokinetic Blood Sample Collection and Processing | 5.9.3 Pharmacokinetic Blood Sample Collection and Processing Blood samples for PK analysis of NGM282 levels will be collected before dosing on Day 1 and Weeks 1, 2, 4, 8, 12, and 16 (no dose administered) as outlined in the Schedule of Study Procedures (Table 5.5-1). On Day 1 and Week 12, an additional PK blood sample ... | [] |
NCT02704364 | 5.9.4 | Clinical Laboratory Assessments | 5.9.4 Clinical Laboratory Assessments Clinical laboratory evaluations including chemistry (fasted at least 10 hours), hematology, and UA will be collected as outlined in the Schedule of Study Procedures (Table 5.5-1). Laboratory assessments of lipid panel (total cholesterol, LDL, HDL, and triglyceride) will be performe... | [] |
NCT02704364 | 5.9.5 | 12-Lead Electrocardiograms | 5.9.5 12-Lead Electrocardiograms 12-lead ECGs will be performed after the subject has been supine for at least 5 minutes, and as outlined in the Schedule of Study Procedures (Table 5.5-1). | [] |
NCT02704364 | 5.9.6 | Vital Signs | 5.9.6 Vital Signs Vital signs (including temperature, respiratory rate, and seated blood pressure and pulse) will be obtained at Screening and at all study visits as outlined in the Schedule of Study Procedures (Table 5.5-1). Seated blood pressure and pulse will be measured after the subject has been seated for at leas... | [] |
NCT02704364 | 5.9.7 | Physical Examinations | 5.9.7 Physical Examinations A routine physical examination will be performed at Screening, Day 1, and Weeks 2, 4, 8, 12, and 16 as outlined in the Schedule of Study Procedures (Table 5.5-1). The physical examination may be performed by a physician, trained physician's assistant, or a nurse practitioner, as acceptable a... | [] |
NCT02704364 | 5.9.8 | Weight | 5.9.8 Weight Subjects will be weighed at Screening, Day 1, and Weeks 4, 8, 12, and 16 as outlined in the Schedule of Study Procedures (Table 5.5-1). | [] |
NCT02704364 | 5.9.9 | Local Injection-Site Symptom Assessments | 5.9.9 Local Injection-Site Symptom Assessments Injection-site evaluation will be made and documented (including photographs, as needed) by the PI or clinic staff using a LISSA (Appendix A). The LISSA is to be administered pre-dose at Day 1 and Weeks 1, 2, 4, 8, 12, and 16 (End of Study) as outlined in the Schedule of S... | [] |
NCT02704364 | 5.9.10 | Numeric Rating Scale for Pruritus and Fatigue | 5.9.10 Numeric Rating Scale for Pruritus and Fatigue An 11-point numeric rating scale for both pruritus and fatigue will be completed by subjects as a daily diary during Day 1 and Weeks 1, 4, and 12 as outlined in the Schedule of Study Procedures (Table 5.5-1). Diary will be dispensed at the study visit prior to the co... | [] |
NCT02704364 | 5.9.11 | 5-D Pruritus Scale | 5.9.11 5-D Pruritus Scale The 5-D Pruritus Scale (Appendix C) is a modified version of the Total Neuropathy Scale (Elman et al. 2010). It is a brief multidimensional questionnaire used to measure the chronic itch. The instrument claims to serve as a monitoring instrument for the long-term course of pruritus. This instr... | [] |
NCT02704364 | 5.9.12 | Mayo Partial IBD Score | 5.9.12 Mayo Partial IBD Score The Mayo Partial IBD Score (Appendix D) is a non-invasive 9-point partial Mayo score used as an outcome measure for clinical trials assessing therapy for ulcerative colitis (Lewis et al. 2008). The partial score evaluates changes in stool frequency, rectal bleeding, and physician assessmen... | [] |
NCT02704364 | 6 | STUDY DRUG | 6 STUDY DRUG | [] |
NCT02704364 | 6.1 | CLINICAL SUPPLIES | 6.1 CLINICAL SUPPLIES  | [] |
NCT02704364 | 6.2 | STUDY DRUG ACCOUNTABILITY | 6.2 STUDY DRUG ACCOUNTABILITY The PI is responsible for ensuring that a current record of inventory/drug accountability is maintained. Inventory records must be readily available for inspection by the study monitor and are open to inspection by regulatory authorities at any time. Each shipment of drug supply for the st... | [] |
NCT02704364 | 6.3 | STUDY DRUG STORAGE | 6.3 STUDY DRUG STORAGE At the clinical site, study drug is to be stored refrigerated at 2°C–8°C (36°F–46°F) in a secure, controlled-access location protected from light. At the subject's home, study drug is to be stored refrigerated at 2°C–8°C (36°F–46°F) in a location protected from light (e.g., their refrigerator). S... | [] |
NCT02704364 | 6.4 | DOSE PREPARATION AND ADMINISTRATION | 6.4 DOSE PREPARATION AND ADMINISTRATION Subjects will be instructed to self-administer/dose at approximately the same time each morning over the 12-week treatment period. Study-drug syringes for SC injection should be 27 May 2016 Page 46 of 71 brought to room temperature prior to use. Study drug will be administered as... | [] |
NCT02704364 | 6.5 | REMOVAL OF STUDY BLIND | 6.5 REMOVAL OF STUDY BLIND This will be a double-blind, placebo-controlled study. Breaking of the blind will be available to the PI through an . The subject's treatment assignment will be available to the PI in the event of a medical emergency or an AE that necessitated identification of the study drug for the welfare ... | [] |
NCT02704364 | 7 | ADVERSE EVENTS | 7 ADVERSE EVENTS | [] |
NCT02704364 | 7.1 | DEFINITION AND GRADING OF SEVERITY OF ADVERSE EVENTS | 7.1 DEFINITION AND GRADING OF SEVERITY OF ADVERSE EVENTS An AE is defined as any untoward medical occurrence in a subject of clinical investigational participation administered a pharmaceutical product, whether or not considered drug related. A TEAE is an AE that is reported after administration of a dose of study drug... | [] |
NCT02704364 | 7.2 | CRITERIA FOR DETERMINING RELATIONSHIP TO DRUG | 7.2 CRITERIA FOR DETERMINING RELATIONSHIP TO DRUG The PI will make a blinded determination of the relationship of the AE to the study drug (including placebo) using a four-category system (not related, possible, probable, definite) according to the following guidelines: - NOT RELATED = an AE that does not follow a reas... | [] |
NCT02704364 | 7.3 | REPORTING | 7.3 REPORTING An SAE is any untoward medical occurrence at any dose that results in any of the following outcomes: - Death - A life-threatening event (i.e., places the subject, in the view of the PI, at immediate risk of death) - Inpatient hospitalization or prolongation of existing hospitalization - A persistent or si... | [] |
NCT02704364 | 7.3.1 | Serious Adverse Events Notification Requirements | 7.3.1 Serious Adverse Events Notification Requirements Any SAE must be reported by the Investigator, immediately or within 24 hours of awareness of the event, through data entry in the Adverse Event eCRF via the Medidata Rave® electronic data capture system. If the Investigator does not become aware of the SAE immediat... | [] |
NCT02704364 | 8 | DATA ANALYSIS AND STATISTICAL CONSIDERATIONS | 8 DATA ANALYSIS AND STATISTICAL CONSIDERATIONS Details of statistical parameters and methods to be applied will be provided in a detailed Statistical Analysis Plan (SAP) prior to database lock (unblinding). | [] |
NCT02704364 | 8.1 | SAMPLE SIZE | 8.1 SAMPLE SIZE A sample size of 20 subjects randomized per treatment group was chosen in light of logistical needs and so as to accumulate sufficient safety data on NGM282. The associated power to detect a treatment difference in the primary efficacy analysis, for either NGM282 comparison versus placebo, is at least 9... | [
"A. ALP Population Mean Change from Baseline:"
] |
NCT02704364 | 8.2 | RANDOMIZATION | 8.2 RANDOMIZATION At Day 1, all eligible subjects will be randomized to one of the three treatment arms (NGM282 1 mg, NGM282 3 mg, or placebo) in a 1:1:1 ratio. The randomization will be stratified by UDCA status (yes/no), to ensure an even distribution across the three treatment groups. That status will be based on co... | [] |
NCT02704364 | 8.3 | TEST OF HYPOTHESIS AND SIGNIFICANCE LEVELS | 8.3 TEST OF HYPOTHESIS AND SIGNIFICANCE LEVELS The null hypothesis being tested for this study will be that there is no difference between the active (1 mg or 3 mg NGM282, as applicable) and the Placebo treatment groups at Week 12 in the population mean change from Baseline in ALP. However, trial success will depend on... | [] |
NCT02704364 | 8.4 | ANALYSIS SETS | 8.4 ANALYSIS SETS The analysis sets are detailed below. Details of any others will be described in the SAP. | [] |
NCT02704364 | 8.4.1 | Randomized Set | 8.4.1 Randomized Set All randomized subjects will be included in the Randomized Set. In analyses using this set, subjects will be grouped according to randomized treatment if this differs from actual treatment received. | [] |
NCT02704364 | 8.4.2 | Safety Set | 8.4.2 Safety Set All randomized subjects who receive at least one dose (full or partial) of study drug and have at least one post-dose safety evaluation will be included in the Safety Set. In analyses using this set, subjects will be grouped according to actual treatment received if this differs from the randomized tre... | [] |
NCT02704364 | 8.4.3 | Full Analysis Set | 8.4.3 Full Analysis Set All randomized subjects who receive at least one dose (full or partial) of study drug and have at least one valid, non-missing post-dose efficacy/PD parameter value will be included in the Full Analysis Set (FAS). This will be the set for the primary analyses of efficacy and PD endpoints. In FAS... | [] |
NCT02704364 | 8.4.4 | Per Protocol Set | 8.4.4 Per Protocol Set The Per Protocol Set (PPS) will constitute a subset of the FAS. It will include subjects who have at least one valid, non-missing post-dose ALP measurement. In addition, FAS subjects who deviate from the conduct of the study or have an AE deemed by the Medical Monitor to be impactful on the prima... | [] |
NCT02704364 | 8.4.5 | Pharmacokinetic Set | 8.4.5 Pharmacokinetic Set All randomized participants who receive at least one dose (full or partial) of blinded drug, had a pre-dose (Baseline) blood draw, and provided at least one qualified (above the limit of quantification) post-dose sample will be included in the PK Set. Subjects with protocol violations will be ... | [] |
NCT02704364 | 8.5 | SUBJECT DISPOSITION | 8.5 SUBJECT DISPOSITION Individual data listings for subject disposition will be presented for each subject, including enrollment date, treatment start date, treatment discontinuation date, discontinuation reason, and analysis set flags. The number and percentage of subjects entering and discontinuing the study will be... | [] |
NCT02704364 | 8.6 | TREATMENT EXPOSURE | 8.6 TREATMENT EXPOSURE Measures of extent of treatment exposure include the total number of doses per subject and compliance. Treatment compliance is defined as the number of doses administered per protocol/number of doses prescribed per protocol. These measures will be summarized using the Safety Set. | [] |
NCT02704364 | 8.7 | PROTOCOL DEVIATIONS | 8.7 PROTOCOL DEVIATIONS Protocol deviations will be summarized using the FAS. | [] |
NCT02704364 | 8.8 | DEMOGRAPHICS AND OTHER BASELINE CHARACTERISTICS | 8.8 DEMOGRAPHICS AND OTHER BASELINE CHARACTERISTICS Demographics, medical history, and other Baseline characteristics will be summarized using the Randomized Set, FAS, and Safety Set. 27 May 2016 Page 54 of 71 | [] |
NCT02704364 | 8.9 | EFFICACY AND PHARMACODYNAMICS | 8.9 EFFICACY AND PHARMACODYNAMICS | [] |
NCT02704364 | 8.9.1 | Efficacy and Pharmacodynamic Endpoints | 8.9.1 Efficacy and Pharmacodynamic Endpoints The primary efficacy endpoint is the mean change in ALP from Baseline at Week 12. The secondary efficacy and PD endpoints are the following: e Percent change from Baseline at Week 12 in ALP - e Absolute and percent changes from Baseline at Week 12 in the following: - o ALT, ... | [
"Exploratory PD Endpo:"
] |
NCT02704364 | 8.9.2 | Analysis of Primary Efficacy Endpoint | 8.9.2 Analysis of Primary Efficacy Endpoint As the primary efficacy analysis, the population mean change in ALP from Baseline to Week 12 will be compared between treatment groups using a mixed-effect model repeated measures (MMRM) analysis of covariance (ANCOVA) of the primary efficacy endpoint, using the FAS. The mode... | [] |
NCT02704364 | 8.9.3 | Analysis of Secondary Endpoints | 8.9.3 Analysis of Secondary Endpoints The analysis of secondary endpoints will be based on the FAS. The primary efficacy analysis will be repeated for each continuous secondary efficacy endpoint. Further explanatory variables may be included in the modeling depending on the relevance to the endpoint analyzed and will b... | [] |
NCT02704364 | 8.9.4 | Analysis of Exploratory PD Endpoints | 8.9.4 Analysis of Exploratory PD Endpoints The analysis of exploratory PD endpoints will be based on the FAS. The primary efficacy analysis will be repeated for each continuous exploratory PD endpoint. Further explanatory variables may be included in the modeling depending on the relevance to the endpoint analyzed and ... | [] |
NCT02704364 | 8.10 | SAFETY AND TOLERABILITY | 8.10 SAFETY AND TOLERABILITY Safety and tolerability will be assessed by clinical review and summaries of the following parameters: - 1. AEs - 2. Clinical laboratory test results - 3. Physical examination results - 4. LISSAs - 5. ECG results - 6. ISRs - 7. Changes and percent changes in total cholesterol, HDL cholester... | [] |
NCT02704364 | 8.10.1 | Adverse Events | 8.10.1 Adverse Events AEs, including SAEs, will be coded using the MedDRA. The number and percentage of subjects experiencing an AE will be summarized for each system organ class (SOC) and preferred term (PT) by treatment group. In addition, AEs will be tabulated according to severity, causality, and relation to the st... | [] |
NCT02704364 | 8.10.2 | Clinical Laboratory Evaluations | 8.10.2 Clinical Laboratory Evaluations The values and percentage changes from Baseline at Week 12 of total cholesterol, HDL cholesterol, and LDL cholesterol will be summarized. Observed values and absolute changes from Baseline for routine chemistry, hematology, and urinalysis values will be summarized at each per-prot... | [] |
NCT02704364 | 8.10.3 | Physical Examinations | 8.10.3 Physical Examinations Physical examination results will be listed for each subject. | [] |
NCT02704364 | 8.10.4 | Vital Signs | 8.10.4 Vital Signs Observed values as well as changes from Baseline will be summarized for all vital-sign parameters, by time point and treatment group. | [] |
NCT02704364 | 8.10.5 | Pregnancy Test | 8.10.5 Pregnancy Test Urine and serum pregnancy test data will be listed for each female subject. | [] |
NCT02704364 | 8.10.6 | Electrocardiogram | 8.10.6 Electrocardiogram Observed values as well as changes from Baseline will be summarized for all ECG parameters, by time point and treatment group. | [] |
NCT02704364 | 8.10.7 | Injection-Site Reactions | 8.10.7 Injection-Site Reactions Frequency tabulations of ISRs will be presented at each time point by treatment group. | [] |
NCT02704364 | 8.10.8 | Prior and Concomitant Medications | 8.10.8 Prior and Concomitant Medications Non-study medications will be classified as prior and concomitant, and coded using the current version of the World Health Organization Drug Dictionary Enhanced (WHO-DD). Prior medications are defined as those taken at least once during the 28 days before Screening. Concomitant ... | [] |
NCT02704364 | 8.10.9 | Interim Analysis | 8.10.9 Interim Analysis An unblinded interim analysis (IA) will be conducted when approximately 24 subjects (a minumum of 8 subjects per arm) have completed the Week 12 visit. At the IA, the evidence regarding the safety and efficacy of NGM282 in the PSC indication will be assessed, in order to evaluate the appropriate... | [] |
NCT02704364 | 8.11 | PHARMACOKINETICS | 8.11 PHARMACOKINETICS The following PK parameters will be calculated using the PK Set and the validated PK software, Phoenix WinNonlin, Version 5.3 (or higher; Certara Corporation; Princeton, NJ, U.S.): - Day 1; Weeks 1, 2, 4, 8, and 12: trough concentration (Ctrough) - Day 1 and Week 12: Ctrough; concentration at 2 ho... | [] |
NCT02704364 | 9 | DATA MANAGEMENT AND ELECTRONIC SYSTEMS | 9 DATA MANAGEMENT AND ELECTRONIC SYSTEMS | [] |
NCT02704364 | 9.1 | DATA MANAGEMENT | 9.1 DATA MANAGEMENT A data validation manual (DVM) will specify all relevant aspects of data processing and handling for the study, including how data will be managed and cleaned. Relevant sections of the DVM includes the following: standard operating procedures to be followed; eCRF data entry and flow, tracking and fi... | [] |
NCT02704364 | 9.2 | ELECTRONIC SYSTEMS | 9.2 ELECTRONIC SYSTEMS Electronic systems used to collect and process data in this study will include the following: - Contracted CRO's randomization and dispensing study-drug supply - Medidata Rave for general data capture - PreClarus real-time study data and analysis - Statistical Analysis Software (SAS) data reconci... | [] |
NCT02704364 | 10 | ADMINISTRATIVE ASPECTS | 10 ADMINISTRATIVE ASPECTS | [] |
NCT02704364 | 10.1 | PROTOCOL ADHERENCE | 10.1 PROTOCOL ADHERENCE The PI must adhere to the protocol as detailed in this document and agree that the Sponsor must approve any changes to the protocol prior to seeking approval from the EC. No alterations in the protocol will occur without agreement between the Sponsor and the PI. No alterations in the protocol af... | [] |
NCT02704364 | 10.2 | DISCLOSURE | 10.2 DISCLOSURE All information provided regarding the study as well as all information collected/documented during the course of the study will be regarded as confidential. The PI agrees not to disclose such information in any way without prior written permission from the Sponsor. Any publication of the results either... | [] |
NCT02704364 | 10.3 | MONITORING | 10.3 MONITORING The Sponsor's or designee's monitor (i.e., "the monitor") will be responsible for monitoring this clinical trial. The monitor will review the study conduct, proper eCRF and source documentation completion and retention, and accurate study-drug accountability. To this end, the monitor will visit the stud... | [] |
NCT02704364 | 10.4 | INSTITUTIONAL REVIEW BOARD/ETHICS COMMITTEE | 10.4 INSTITUTIONAL REVIEW BOARD/ETHICS COMMITTEE This protocol, the informed consent document, and all relevant supporting data must be submitted to the IRB/EC for approval. IRB/EC approval of the protocol, informed consent document, and any advertisement used to recruit study subjects must be obtained before the study... | [] |
NCT02704364 | 10.5 | INFORMED CONSENT | 10.5 INFORMED CONSENT This study will be conducted in compliance with ICH E6 Good Clinical Practice: Consolidated Guidelines pertaining to informed consent. At the first visit, prior to initiation of any study-related procedures, patients must give their written consent to participate in the study after having been inf... | [] |
NCT02704364 | 10.6 | RECORDS | 10.6 RECORDS The results from Screening and data collected during the study will be recorded in the subject's eCRF. To maintain confidentiality, the subjects will be identified only by numbers and initials. The completed eCRFs will be transferred to the Sponsor or designee. Copies of each eCRF will be retained by the P... | [] |
NCT02704364 | 10.7 | DATA MONITORING COMMITTEE | 10.7 DATA MONITORING COMMITTEE A Data Monitoring Committee (DMC) will be established in order to protect subject welfare, preserve study integrity, and provide recommendations as needed regarding study conduct. The DMC will be comprised of two external liver disease clinical experts as well as a statistician and a medi... | [] |
NCT02704364 | 10.8 | FINANCING AND INSURANCE | 10.8 FINANCING AND INSURANCE The financing and insurance for this study are outlined in the Clinical Trial Research Agreement. 27 May 2016 Page 62 of 71
INVESTIGATOR PROTOCOL REVIEW AND SIGNATURE FORM | Protocol Number: | 15-0106 | | |------------------|-----------------------------------------------------------------... | [
"INVESTIGATOR PROTOCOL REVIEW AND SIGNATURE FORM",
"SPONSOR PROTOCOL APPROVAL AND SIGNATURE PAGE Protocol Number: 15-0106",
"REFERENCES",
"APPENDIX A–FOOD AND DRUG ADMINISTRATION TOXICITY GRADING SCALE IN LOCAL INJECTION-SITE SYMPTOM ASSESSMENTS",
"APPENDIX B—NUMERIC RATING SCALE FOR ITCH AND FATIGUE",
"I... |
NCT02736409 | 1 | BACKGROUND INFORMATION | 1. BACKGROUND INFORMATION | [] |
NCT02736409 | 1.1 | Indication and Current Treatment Options | 1.1 Indication and Current Treatment Options Eosinophilic esophagitis (EoE) is defined as "a chronic, immune/antigen-mediated esophageal disease characterized clinically by symptoms related to esophageal dysfunction and histologically by eosinophil-predominant inflammation" (Liacouras et al., 2011). Clinical symptoms o... | [] |
NCT02736409 | 1.2 | Product Background and Clinical Information | 1.2 Product Background and Clinical Information Oral budesonide suspension (OBS) consists of budesonide formulated in a viscous suspension that is designed to increase the residence time of budesonide on the surface of the esophagus after swallowing compared to a nonviscous suspension. Shire is developing OBS as a firs... | [] |
NCT02736409 | 2.1 | Rationale for the Study | 2.1 Rationale for the Study Currently there is no approved medication for the treatment of EoE. This Phase 3 study is being conducted to determine response to withdrawal of OBS, maintenance of response, extended therapy response, and response to intermittent therapy by evaluating both eosinophil counts and DSQ in adole... | [] |
NCT02736409 | 2.2 | Study Objectives | 2.2 Study Objectives | [] |
NCT02736409 | 2.2.1 | Primary Objective | 2.2.1 Primary Objective The primary objective of the study is: To evaluate the maintenance of efficacy over 36 weeks, as measured by the peak eosinophilic count and the Dysphagia Symptom Questionnaire (DSQ) score, through a randomized withdrawal design for subjects who responded to 12 weeks of OBS treatment (2 mg twice... | [] |
NCT02736409 | 2.2.2 | Secondary Objectives | 2.2.2 Secondary Objectives The key secondary objective of this study is: To evaluate the long-term treatment response over an extended period of 36 weeks for subjects who were randomized to OBS treatment but did not respond after 12 weeks in the SHP621-301 induction study (subject did not have a peak count of ≤6 eos/HP... | [] |
NCT02736409 | 2.2.3 | Exploratory Objectives | 2.2.3 Exploratory Objectives The exploratory objectives of this study are:  | [] |
NCT02736409 | 3 | STUDY DESIGN | 3. STUDY DESIGN | [] |
NCT02736409 | 3.1 | Study Design and Flow Chart | 3.1 Study Design and Flow Chart This is a Phase 3, multicenter, double-blind study to evaluate the efficacy, safety and tolerability of OBS treatment administered twice daily (qAM, pc, and hs) for 36 weeks. The study will be conducted in adolescents and adults, aged 11-55 years, inclusive, with EoE and dysphagia who co... | [] |
NCT02736409 | 3.2 | Duration and Study Completion Definition | 3.2 Duration and Study Completion Definition The subject's maximum duration of participation is expected to be approximately 44 weeks, including the 4-week screening period. Including potential treatment in SHP621-301 and the screening period of this study, the maximum total duration of OBS 2 mg twice daily may be appr... | [] |
NCT02736409 | 3.3 | Sites and Regions | 3.3 Sites and Regions Approximately 60 sites in North America, the same sites participating in the SHP621-301 study, will participate in this extension study. For non-commercial use only | [] |
NCT02736409 | 4 | STUDY POPULATION | 4. STUDY POPULATION Each subject must participate in the informed consent process and provide written informed consent/assent before any procedures specified in the protocol are performed. | [] |
NCT02736409 | 4.1 | Inclusion Criteria | 4.1 Inclusion Criteria The subject will not be considered eligible for the study without meeting all of the following criteria (including test results): - 1. Subject completed SHP621-301 induction study. - 2. Subject is able to provide written informed consent (subject, parent or legal guardian and, as appropriate, sub... | [] |
NCT02736409 | 4.2 | Exclusion Criteria | 4.2 Exclusion Criteria Subjects are excluded from the study if any of the following exclusion criteria are met: - 1. Subject has changes in medications that could affect the study or diet in the weeks since the final treatment evaluation visit (Visit 4) of the SHP621-301 study. - 2. Subject using immunomodulatory thera... | [] |
NCT02736409 | 4.3 | Restrictions | 4.3 Restrictions Subjects must adhere to the following restrictions for the duration of the study: - No changes in medications or diet since the final treatment evaluation visit (Visit 4) of the SHP621-301 study. - Temporary use (≤7 days) or initiation of new steroid treatment is permitted but cannot occur within the 4... | [] |
NCT02736409 | 4.4 | Reproductive Potential | 4.4 Reproductive Potential | [] |
NCT02736409 | 4.4.1 | Female Contraception | 4.4.1 Female Contraception All females must have a negative pregnancy test at the screening visit (Visit 0), randomization visit (Visit 1), and Visits 2-8. A serum pregnancy test will be performed at the screening visit (Visit 0) and final treatment evaluation (Visit 8). Urine pregnancy tests will be performed at all o... | [] |
NCT02736409 | 4.5 | Discontinuation of Subjects | 4.5 Discontinuation of Subjects A subject may withdraw from the study at any time for any reason without prejudice to their future medical care by the physician or at the institution. The investigator or sponsor may withdraw the subject at any time (eg, in the interest of subject safety). The investigator is encouraged... | [] |
NCT02736409 | 4.5.1 | Subject Withdrawal Criteria | 4.5.1 Subject Withdrawal Criteria Medically important events that in the opinion of the investigator or medical monitor would compromise the subject's ability to safely continue in the study, including but not limited to an esophageal stricture requiring dilation and/or worsening signs and symptoms of EoE (eg, weight l... | [] |
NCT02736409 | 4.5.2 | Reasons for Discontinuation | 4.5.2 Reasons for Discontinuation The reason for withdrawal must be determined by the investigator and recorded in the subject's medical record and on the CRF. If a subject is withdrawn for more than 1 reason, each reason should be documented in the source document and the most clinically relevant reason should be ente... | [] |
NCT02736409 | 4.5.3 | Subjects "Lost to Follow-up" Prior to Last Scheduled Visit | 4.5.3 Subjects "Lost to Follow-up" Prior to Last Scheduled Visit A minimum of 3 documented attempts must be made to contact any subject lost to follow-up at any time point prior to the last scheduled contact (office visit or telephone contact). At least 1 of these documented attempts must include a written communicatio... | [] |
NCT02736409 | 4.5.4 | Safety-related Stopping Rules | 4.5.4 Safety-related Stopping Rules An urgent safety review will be conducted within 7 days by the sponsor if one or more of the following criteria are met: - Death that is considered related to the study drug - Two SAEs of similar type (defined as same or similar MedDRA higher level group code), and considered related... | [] |
NCT02736409 | 5 | PRIOR AND CONCOMITANT TREATMENT | 5. PRIOR AND CONCOMITANT TREATMENT All nonstudy treatment (including but not limited to herbal treatments, vitamins, behavioral treatment, and nonpharmacological treatment, such as psychotherapy, as appropriate) received at the screening visit (Visit 0) and through the final study contact (including protocol-defined fo... | [] |
NCT02736409 | 5.1 | Prior Treatment | 5.1 Prior Treatment Prior treatment includes all treatment, including but not limited to herbal treatments, vitamins, and nonpharmacological treatment such as psychotherapy, as appropriate, received at the screening visit (Visit 0). Prior treatment information must be recorded on the appropriate CRF page. | [] |
NCT02736409 | 5.2 | Concomitant Treatment | 5.2 Concomitant Treatment Concomitant treatment refers to all treatment taken between the dates of the first dose of investigational product in SHP621-302 (Visit 1) and the end of the follow-up period, inclusive. Concomitant treatment information must be recorded on the appropriate CRF page. The investigator may prescr... | [] |
NCT02736409 | 5.2.1 | Permitted Treatment | 5.2.1 Permitted Treatment The following medications are allowed during the course of the study if the subject has been on a stable dosing regimen (ie, same dose and frequency in the previous 4 weeks prior to the scheduled EGDs) and will continue this dosing regimen throughout study participation. The investigator must ... | [] |
NCT02736409 | 5.2.2 | Prohibited Treatment | 5.2.2 Prohibited Treatment The following medications and treatments are prohibited throughout the course of the study and prior to treatment, as specified: - 1. Immunomodulatory therapy since the final treatment evaluation visit (Visit 4) of the SHP621-301 study or use within the 4 weeks of scheduled EGDs. Any temporar... | [] |
NCT02736409 | 6 | INVESTIGATIONAL PRODUCT | 6. INVESTIGATIONAL PRODUCT | [] |
NCT02736409 | 6.1 | Identity of Investigational Product | 6.1 Identity of Investigational Product The test product is OBS (oral budesonide suspension, 0.2 mg/mL), which will be provided in 8 ounce amber glass, multidose bottles. Additional information is provided in the current SHP621 investigator's brochure. The reference/comparator product is placebo, which will be provided... | [] |
NCT02736409 | 6.1.1 | Blinding the Treatment Assignment | 6.1.1 Blinding the Treatment Assignment Investigational product will be supplied in 8 ounce amber glass, multidose bottles with child-resistant caps and refrigerated throughout the study (in the clinic and subject's home). Each bottle contains OBS concentration of 0.2 mg/mL. Inactive ingredients in OBS include dextrose... | [] |
NCT02736409 | 6.2 | Administration of Investigational Product(s) | 6.2 Administration of Investigational Product(s) All investigational product and supplies (eg, dosing spoons) will be provided by Shire or its designee. At each visit, subjects will be supplied with enough investigational product to last until the subsequent visit. The first dose of investigational product for each sub... | [] |
NCT02736409 | 6.2.1 | Interactive Response Technology for Investigational Product Management | 6.2.1 Interactive Response Technology for Investigational Product Management An interactive web-based response system (IWRS) will be used for screening and enrolling subjects, recording subject visits, randomization, investigational product supply dispensation and management, inventory management and supply ordering, i... | [] |
NCT02736409 | 6.2.2 | Allocation of Subjects to Treatment | 6.2.2 Allocation of Subjects to Treatment This study consists of a 4-week screening period and a double-blind treatment period. The actual treatment given to individual subjects during the double-blind treatment period will be determined by the blinded treatment response information entered at the SHP621-301 final trea... | [] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.