protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03252353 | 5.2 | DOUBLE-BLIND PLACEBO-CONTROLLED (DPC) PERIOD (WEEK 1 TO WEEK 36) | 5.2 DOUBLE-BLIND PLACEBO-CONTROLLED (DPC) PERIOD (WEEK 1 TO WEEK 36) Patients meeting the eligibility criteria will be randomized at Baseline in 1:1 ratio to one of two treatment arms: Octreotide capsules or matching placebo capsules. All efforts should be made to 1 Including assay used and/or reference ranges  Patients meeting the eligibility criteria will be randomized at Baseline in 1:1 ratio to one of two treatment arms: - 1. Octreotide capsules - 2. Matching placebo capsules The following assessments and procedures will be performed at Baseline (BL) Visitx - o Inclusion and e... | [
"lipoprotein)",
"Morning Dose",
"Evening Dose"
] |
NCT03252353 | 5.2.2 | Telephone Call at Week 1 and Week 2 | 5.2.2 Telephone Call at Week 1 and Week 2 The following assessments and procedures will be performed on the pre-scheduled telephone calls at Week 1 and 2: - AEs recording - Drug administration instructions (including assessments for dose titration) - Address any potential questions the patient may have with the new tre... | [] |
NCT03252353 | 5.2.3 | DPC Clinic Visits (Weeks 4, 8, 12, 16, 20, 24, 28, 32, 34, 36) | 5.2.3 DPC Clinic Visits (Weeks 4, 8, 12, 16, 20, 24, 28, 32, 34, 36) The following procedures and assessments will be conducted during DPC period visits: - Weight - Vital signs - Safety laboratory tests: hematology and biochemistry - IGF-1 - Acromegaly directed and treatment directed physical examination - AEs includin... | [] |
NCT03252353 | 5.3 | OPEN-LABEL EXTENSION (OLE) PERIOD | 5.3 OPEN-LABEL EXTENSION (OLE) PERIOD All patients who complete the core study (Screening and DPC period) on study medications (octreotide capsules or placebo), or patients who met the pre-defined withdrawal criteria and were followed per protocol until week 36 on prior SRL injections (as rescue medication), will be of... | [] |
NCT03252353 | 5.4 | END OF TREATMENT (EOT) VISIT | 5.4 END OF TREATMENT (EOT) VISIT End of Treatment (EOT) visit is scheduled for patients who discontinued study medication prematurely during DPC period and OLE period. This visit may be performed on a same day as originally scheduled visit or could be scheduled separately. Data collection for this visit should primaril... | [] |
NCT03252353 | 5.5 | FOLLOW-UP PERIOD | 5.5 FOLLOW-UP PERIOD Patients who discontinue study medication any time during the OLE period, for any reason, or have completed the 36-week DPC period on study medication and are ineligible or opt not to continue into the OLE period, will revert to their prior injectable SRL treatment (prior to Screening period) or ot... | [] |
NCT03252353 | 5.6 | UNSCHEDULED VISIT | 5.6 UNSCHEDULED VISIT Unscheduled visits will be allowed throughout the study for safety, tolerability or management of active disease, per the Investigator discretion. If IGF-1 ≥1.3 × ULN at any visit, or upon physician assessment of exacerbation of clinical symptoms, the patient should be invited to an unscheduled vi... | [] |
NCT03252353 | 5.7 | EFFICACY ASSESSMENTS | 5.7 EFFICACY ASSESSMENTS | [] |
NCT03252353 | 5.7.1 | IGF-1 and GH | 5.7.1 IGF-1 and GH IGF-1 and GH levels will be assessed by a central laboratory. IGF-1 concentration in the blood will be assessed at all study visits (single sample). GH concentration in the blood will be assessed at selected study visits (as specified in Schedule of Assessments Appendix A). Blood samples for GH will ... | [] |
NCT03252353 | 5.8 | SAFETY ASSESSMENTS | 5.8 SAFETY ASSESSMENTS Safety assessments include AEs (either reported by the patient or observed by the Investigator),  concomitant medication use, vital signs, ECG, physical examination, abdominal (gall bladder) ultrasound, and laboratory assessments; these assessments will be conducted as spe... | [] |
NCT03252353 | 5.8.1 | Adverse Events | 5.8.1 Adverse Events Adverse events (AEs) will be assessed at all study visits throughout the study from informed consent signing. Any AEs that occur throughout the study (including the follow up periods) will be recorded (Refer to Section 7). Any new AE or exacerbation of existing condition (including acromegaly sympt... | [] |
NCT03252353 | 5.8.2 | Medical History and Concomitant Medications | 5.8.2 Medical History and Concomitant Medications Any diseases that are ongoing at screening and before the baseline will be documented in the medical history and concomitant disease section of the eCRF. The diagnosis of concomitant disease resulting from assessment at the screening must be also documented in the medic... | [] |
NCT03252353 | 5.8.3 | Vital Signs | 5.8.3 Vital Signs Vital signs will be measured at all study visits and will include blood pressure and heart rate, at rest as per standard practice at the investigational site. Significant findings noticed after the start of study medication which meet the definition of an AE must be recorded on the AE eCRF. | [] |
NCT03252353 | 5.8.4 | ECG Assessment | 5.8.4 ECG Assessment Twelve-lead ECG will be done as specified in Schedule of Assessments (Appendix A). Any ECG abnormality determined by the Investigator to be clinically significant will be noted as an AE on the appropriate eCRF page(s). Such abnormalities will closely be monitored up to their resolution. | [] |
NCT03252353 | 5.8.5 | Physical Examination | 5.8.5 Physical Examination Complete physical examination will be conducted on as specified in Schedule of Assessments (Appendix A). Acromegaly directed and treatment directed physical examination (Appendix B), will be conducted as specified in Schedule of Assessments (Appendix A). It will include assessment of physical... | [] |
NCT03252353 | 5.8.6 | Abdominal Ultrasound | 5.8.6 Abdominal Ultrasound Abdominal ultrasound will be conducted to monitor gall bladder and biliary tract disease as specified in Schedule of Assessments (Appendix A). Abdominal ultrasound may be repeated during the treatment period to comply with local guidelines. Evidence of cholelithiasis, biliary sludge, and bile... | [] |
NCT03252353 | 5.8.7 | Safety Laboratory Assessments | 5.8.7 Safety Laboratory Assessments All clinical laboratory assessments will be performed by a central laboratory (except for urine pregnancy test). Blood sampling will be done under fasting conditions (at least eight hours). Fasting conditions may be altered on a case-by-case basis, per the Investigator's clinical dis... | [] |
NCT03252353 | 6.1.1 | Octreotide Capsules | 6.1.1 Octreotide Capsules Octreotide capsule is a novel, orally-administered formulation of the well-characterized and commercially-available parenteral drug octreotide. Octreotide capsule is a capsule filled with an oily suspension of octreotide formulated with proprietary TPE excipients. The TPE facilitates paracellu... | [] |
NCT03252353 | 6.1.2 | Placebo | 6.1.2 Placebo Matching placebo capsules, identical in appearance (shape, color and markings) to octreotide capsis 6.2 STUDY MEDICATION ADMINISTRATION Study medication should be administered twice daily with a glass of water (240 mL) on an empty stomach, i.e. at least one hour prior to a meal or at least two hours after... | [
"Morning Dose",
"Evening Dose"
] |
NCT03252353 | 6.5 | MANUFACTURING OF STUDY MEDICATIONS | 6.5 MANUFACTURING OF STUDY MEDICATIONS Octreotide capsule and matching placebo are manufactured for Chiasma, Inc. under good manufacturing practices (GMP) by , UK. Certain manufacturing operations have been performed by other firms. | [] |
NCT03252353 | 6.6 | PACKAGING AND LABELING OF STUDY MEDICATION | 6.6 PACKAGING AND LABELING OF STUDY MEDICATION Octreotide capsules and matching placebo capsules will appear as enteric-coated capsules provided by the Sponsor in wallets containing 28 capsules. The wallets will be packaged and labeled in compliance with the EU GMP, Annex 13 of drugs used in clinical trials and with FD... | [] |
NCT03252353 | 6.7 | DISTRIBUTION AND RECEIPT OF STUDY MEDICATION | 6.7 DISTRIBUTION AND RECEIPT OF STUDY MEDICATION For detailed information on the distribution and receipt of study medication please refer to the Study Pharmacy Manual. The study medications will be shipped under appropriate conditions with temperature monitoring device for supplies that need to be shipped under refrig... | [] |
NCT03252353 | 6.8 | STORAGE OF STUDY MEDICATION | 6.8 STORAGE OF STUDY MEDICATION The pharmacist (or other authorized designee) is responsible for ensuring that the appropriate storage conditions for the investigational products are maintained in accordance with the requirements in the Study Pharmacy Manual. Wallets containing enteric-coated octreotide capsules or mat... | [] |
NCT03252353 | 6.9 | ACCOUNTABILITY AND COMPLIANCE OF STUDY MEDICATION | 6.9 ACCOUNTABILITY AND COMPLIANCE OF STUDY MEDICATION The Investigator or pharmacist/designee may dispense study medication(s) only to patients enrolled in the study. Individual patient accountability records must be kept by the site staff. The patient number, the date, batch number/wallet number, and quantity of study... | [] |
NCT03252353 | 6.10 | PRIOR AND CONCOMITANT THERAPY | 6.10 PRIOR AND CONCOMITANT THERAPY | [] |
NCT03252353 | 6.10.1 | General Guidelines | 6.10.1 General Guidelines All prior treatments received by the patient, e.g. general use since diagnosis (list of prior medications for acromegaly any time in the past), medications for acromegaly within the last year (including the last dose of SRL injection) and medications for other conditions – within the last 12 w... | [] |
NCT03252353 | 6.10.2 | Prohibited Prior Medications or Therapies | 6.10.2 Prohibited Prior Medications or Therapies The following are prohibited prior medications or therapies: - Treatment with pegvisomant within 24 weeks before the first screening visit - Treatment with dopamine agonists within 12 weeks before the first screening visit - Treatment with pasireotide within 24 weeks bef... | [] |
NCT03252353 | 6.10.3 | Allowed Medications | 6.10.3 Allowed Medications Other than the investigational medicinal drugs, concomitant medications allowed to be used in this study are those used at screening to control existing medical condition, and/or those taken during the study to treat possible AEs. Per the Investigator discretion, new/worsening acromegaly clin... | [] |
NCT03252353 | 6.10.4 | Prohibited Concomitant Medication | 6.10.4 Prohibited Concomitant Medication Women taking oral contraception containing levonorgestrel are advised to switch to another oral contraceptive or barrier method. Investigational therapy for the treatment of acromegaly are prohibited during the course of the study. Parenteral SRLs or dopamine agonists, GH antago... | [] |
NCT03252353 | 7 | SAFETY AND PHARMACOVIGILANCE | 7 SAFETY AND PHARMACOVIGILANCE | [] |
NCT03252353 | 7.1 | ADVERSE EVENT | 7.1 ADVERSE EVENT The FDA defines an AE as "Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related" (US Department of Health and Human Services Food and Drug Administration December 2012). An AE (also referred to as an adverse experience) ... | [
"Follow-up Reports for Non-Serious AEs"
] |
NCT03252353 | 7.1.1 | Adverse Events of Special Interest | 7.1.1 Adverse Events of Special Interest New or worsening acromegaly signs and/or symptoms will be recorded as adverse events ofspecial interest (AESI) and are headache, fatigue, perspiration, soft tissue swelling, arthralgia, dysglycemia or hypertension or other signs that in view of the Investigator are related to ac... | [
"Table 4 Hypertension Severity criteria"
] |
NCT03252353 | 7.2 | SERIOUS ADVERSE EVENTS | 7.2 SERIOUS ADVERSE EVENTS An SAE is any AE occurring at any dose that suggest a significant hazard or side effect, regardless of the Investigator or Sponsor's opinion on the relationship to the study medication and that result in, but may not be limited to, any of the following outcomes: - Death (regardless of the cau... | [] |
NCT03252353 | 7.3 | DEFINITION OF AN UNEXPECTED ADVERSE EVENT | 7.3 DEFINITION OF AN UNEXPECTED ADVERSE EVENT An unexpected adverse event is any AE, the specificity or severity of which is not consistent with information in the clinical protocol or current Investigator's Brochure for an unapproved study medication or package insert/summary of product characteristics for an approved... | [] |
NCT03252353 | 7.4 | NOTIFICATION OF SERIOUS UNEXPECTED SUSPECTED ADVERSE EVENT | 7.4 NOTIFICATION OF SERIOUS UNEXPECTED SUSPECTED ADVERSE EVENT The Investigator is responsible for identifying, documenting, evaluating and reporting SAEs in accordance with the protocol, 21CFR312.32, 21CFR312.64, International Council for Harmonisation (ICH) guidelines, and all other applicable regulations.
Initial N... | [
"Initial Notification",
"Follow-up of SAEs / SUSARs"
] |
NCT03252353 | 7.5 | ANTICIPATED ADVERSE EVENTS | 7.5 ANTICIPATED ADVERSE EVENTS Previous human experience and known AEs of octreotide are detailed in the corresponding IB. | [] |
NCT03252353 | 7.6 | OCTREOTIDE SAFETY GUIDANCE | 7.6 OCTREOTIDE SAFETY GUIDANCE Below is the Sponsor's safety guidance for using octreotide in case of common GI adverse events, elevated liver function tests (LFTs) and/or blood sugar disorder. These guidelines should be used to guide treatment, however, in any case, should not replace clinical judgment.
Common Gastro... | [
"Common Gastrointestinal Adverse Events",
"Liver Dysfunction",
"Glucose Metabolism"
] |
NCT03252353 | 8.2.1 | Full Analysis Set (FAS) | 8.2.1 Full Analysis Set (FAS) The Full Analysis Set (FAS) is defined as all randomized patients. This population will serve as the primary efficacy analysis population for the DPC period of the study. Patients will be included in the group to which they were randomized. | [] |
NCT03252353 | 8.2.2 | Per-Protocol Analysis Set (PP) | 8.2.2 Per-Protocol Analysis Set (PP) The Per-Protocol Analysis Set (PP) is defined as all patients in the FAS who were compliant with study medication and do not have any major protocol violation. Major protocol violations will be identified prior to breaking the blind. This analysis set will provide supportive to the ... | [] |
NCT03252353 | 8.2.3 | Safety Analysis Set | 8.2.3 Safety Analysis Set The safety set will consist of all randomized subjects who received any amount of study medication. Assuming no dosing errors, the safety set will be the same as the FAS. The safety set will be used for all safety analyses. Subjects will be assigned to a treatment group based on the treatment ... | [] |
NCT03252353 | 8.2.4 | Open Label Extension Analysis Set | 8.2.4 Open Label Extension Analysis Set For the OLE phase, a number of different analysis sets will be defined. - 1. The open label extension (OLE) set will consist of all patients enrolled into the OLE phase of the study who receive at least one dose of open label study drug. - 2. Octreotide capsules patients from the... | [] |
NCT03252353 | 8.3 | ENDPOINTS | 8.3 ENDPOINTS For a description of the endpoints refer to Section 2.2. For a description of the assessment tools, refer to Sections 5.7 and 5.8. | [] |
NCT03252353 | 8.4 | STATISTICAL ANALYSIS | 8.4 STATISTICAL ANALYSIS | [] |
NCT03252353 | 8.4.1 | General Considerations | 8.4.1 General Considerations Descriptive statistics and graphical presentations will be used to provide an overview of the study results. For categorical parameters, the number and percentage of patients in each category will be presented. The denominator for percentages will be based on the number of patients appropri... | [] |
NCT03252353 | 8.4.2 | Demographics and Baseline | 8.4.2 Demographics and Baseline Demographic and baseline characteristics will be summarized by treatment group for the FAS set and the OLE set, by treatment group and overall, using descriptive statistics. If the FAS and safety set are different, then summaries will also be presented for the safety analysis set. No sta... | [] |
NCT03252353 | 8.4.3 | Primary Efficacy Analysis | 8.4.3 Primary Efficacy Analysis The primary efficacy analysis will estimate the proportion of responders, based on the primary endpoint, at the end of the DPC period, within the octreotide capsules and placebo arms. An assessment of superiority will be made using an exact logistic regression model, with covariates for ... | [] |
NCT03252353 | 8.4.4 | Secondary Efficacy Analysis | 8.4.4 Secondary Efficacy Analysis The secondary endpoint defined as the proportion of patients who maintain GH response will utilize the same methods as outlined above for the primary endpoint. Analyses will be presented using both the FAS and the PP analysis set. For the analysis of the proportion of responders based ... | [] |
NCT03252353 | 8.4.5 | Descriptive Endpoint Analysis | 8.4.5 Descriptive Endpoint Analysis The change from baseline for both GH and IGF-1 will be summarized within each treatment group separately, using descriptive statistics. No between group statistical testing will be conducted. | [] |
NCT03252353 | 8.4.6 | Exploratory Efficacy Analysis | 8.4.6 Exploratory Efficacy Analysis The exploratory endpoints that are defined as proportions will utilize the same methods as outlined above for the primary endpoint. Analyses will be presented using both the FAS and the PP analysis set. To help with the interpretation of the primary outcomes, an exploratory supportiv... | [] |
NCT03252353 | 8.4.7 | OLE Period | 8.4.7 OLE Period For all OLE endpoints which are defined as a proportion, the proportion and 2-sided 95% confidence interval (using the Wilson score method, without continuity correction) for the proportion will be reported. For OLE shift analyses, data will be tabulated using descriptive statistics only. For OLE endpo... | [] |
NCT03252353 | 8.4.8 | Safety Analysis | 8.4.8 Safety Analysis All safety analyses for data collected during the DPC period will be presented using the safety set. All safety analyses for data collected during the OLE will be presented using the OLE set (summaries by treatment group will be based on the treatment group in the DPC period). Safety analyses for ... | [] |
NCT03252353 | 8.4.8.1 | Adverse Events | 8.4.8.1 Adverse Events AEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA version 18.1 or higher).  All AEs that occur after randomization (i.e., date of onset is on or after the date of randomization) and on or before the end of treatment (last dose of blinded study dr... | [] |
NCT03252353 | 8.4.8.2 | Laboratory Assessments | 8.4.8.2 Laboratory Assessments Descriptive summary statistics for chemistry and hematology data at each post randomization time point (both absolute and change) will be presented by final dose group and treatment group (i.e., octreotide 40, 60, 80, overall and placebo). Summaries will be provided for the DPC period and... | [] |
NCT03252353 | 8.4.8.3 | Vital Signs and Body Weight | 8.4.8.3 Vital Signs and Body Weight Descriptive statistics of vital sign (systolic blood pressure, diastolic blood pressure, heart rate, body weight) data at each post randomization time point (both absolute and change) will be presented by final dose group and treatment group (i.e., octreotide 40, 60, 80, overall and ... | [] |
NCT03252353 | 8.4.8.4 | ECG, Ultrasound | 8.4.8.4 ECG, Ultrasound All 12-Lead ECGs will be read by a central lab. 12-Lead ECG parameters will be summarized at each time point using descriptive statistics by final dose group and treatment group (i.e., octreotide 40, 60, 80, overall and placebo). Both absolute and change from baseline will be provided for each c... | [] |
NCT03252353 | 8.4.9 | Interim Analyses | 8.4.9 Interim Analyses No interim analysis is planned; however, data will be periodically reviewed by the IDMC for safety purposes. Interim analyses of the OLE period may be conducted periodically for regulatory reporting purposes. These analyses will be conducted by the Sponsor, or its designee.  will act in an advisory capacity to the Sponsor to provide oversight to the trial conduct and to support its successful completion. The SC will also ensure transparent management of the study according to the protocol through recommending and approving modifications as... | [] |
NCT03252353 | 9.6.2 | Independent Data Monitoring Committee | 9.6.2 Independent Data Monitoring Committee An IDMC will be assigned by the Sponsor prior to the beginning of the study. The IDMC will act in an advisory capacity to the Sponsor to monitor patient safety of octreotide capsules in acromegaly patients who participate in the study. The IDMC responsibilities are to: - Revi... | [] |
NCT03252353 | 9.7 | PROTOCOL EXCEPTIONS AND DEVIATIONS | 9.7 PROTOCOL EXCEPTIONS AND DEVIATIONS No protocol deviations are anticipated as it is expected that patients will meet all eligibility criteria. Departures from the protocol should be avoided, unless required for the safety of the patient. Protocol deviations, and if possible the reason for occurrence, will be documen... | [] |
NCT03252353 | 9.8 | PROTOCOL AMENDMENTS | 9.8 PROTOCOL AMENDMENTS Changes to the protocol may be made only by the Sponsor (with or without consultation with the Investigator). All protocol modifications must be submitted to the site IRB/IEC in accordance with local requirements and, if required, to the Regulatory Authority, either as an amendment or a notifica... | [] |
NCT03252353 | 10 | QUALITY CONTROL AND QUALITY ASSURANCE | 10 QUALITY CONTROL AND QUALITY ASSURANCE The study will be conducted according to GCP as outlined by ICH Topic E6 step 5 guidelines. The Sponsor and/or designated CRO maintains a quality assurance system with written standard operating procedures (SOPs) to ensure that clinical trials are conducted and data are generate... | [] |
NCT03252353 | 10.1 | AUDITS AND INSPECTIONS | 10.1 AUDITS AND INSPECTIONS The study may be audited according to the Sponsor's quality assurance (QA) inspection program. The purpose of the audit is to determine whether or not the study is being conducted and monitored in compliance with study protocol and ICH-GCP guideline. Audit visit(s) will be arranged in advanc... | [] |
NCT03252353 | 10.2 | STUDY MONITORING | 10.2 STUDY MONITORING Monitoring of the study is the responsibility of the Sponsor and may be delegated to a CRO or a contract monitor. The study monitor will advise the Investigator regarding the practical conduct of the study and maintaining compliance with the protocol, GCP and all applicable regulatory requirements... | [] |
NCT03252353 | 10.3 | QUALITY LABORATORY STANDARDS | 10.3 QUALITY LABORATORY STANDARDS Laboratory tests or evaluations described in this protocol will be conducted in accordance with quality laboratory standards as described in the SOPs of the local institution laboratory and central laboratories. Before the study begins, the laboratories to be used in the study will pro... | [] |
NCT03252353 | 10.4 | STUDY DOCUMENTATION | 10.4 STUDY DOCUMENTATION Study documents will include the following: - Signed ICFs - Source documents (e.g., patient files, medical notes, study worksheets) - Investigator copies of the eCRFs and SAE reports - Investigator site file + contents - Study Manuals (including laboratory manual, pharmacy manual and reference ... | [] |
NCT03252353 | 10.4.1 | Source Document | 10.4.1 Source Document The Investigator will permit study-related monitoring, audits by or on behalf of the Sponsor, IRB/IEC review and regulatory inspections providing direct access to source data documents. Source documents are original records in which raw data are first recorded. These may be office/clinic/hospital... | [] |
NCT03252353 | 10.4.2 | Recording of Data on Electronic Case Report Form (eCRF) | 10.4.2 Recording of Data on Electronic Case Report Form (eCRF) No data will be directly entered into the eCRF without source documentation. Only a patient identification number will be used to identify the patient in the eCRF. The Investigator must keep a separate log of patient names and medical record numbers (or oth... | [] |
NCT03252353 | 10.4.3 | Investigator Site File | 10.4.3 Investigator Site File All documents required for the conduct of the study as specified in the ICH-GCP guidelines will be maintained by the Investigator in an orderly manner and made available for monitoring and/or auditing by the Sponsor and regulatory agencies. | [] |
NCT03252353 | 10.5 | CLINICAL TRIAL SUPPLIES | 10.5 CLINICAL TRIAL SUPPLIES The Sponsor or its vendors will be responsible for providing study supplies and for ensuring that they are used, managed and accounted for properly. Accurate and timely records of the disposition and accountability of all study drugs must be maintained by the site and reviewed by the Sponso... | [] |
NCT03252353 | 10.6 | DATA MANAGEMENT | 10.6 DATA MANAGEMENT Data Management services will be provided by the CRO. After the data have been entered and verified, various edit checks will be performed for the purpose of ensuring the accuracy, integrity, and validity of the database. These edit checks may include: - Missing value checks - Range checks - Consis... | [] |
NCT03252353 | 11 | STUDY ADMINISTRATION | 11 STUDY ADMINISTRATION | [] |
NCT03252353 | 11.1 | PARTICIPATING CENTERS | 11.1 PARTICIPATING CENTERS This will be a multicenter, worldwide study (including US sites). | [] |
NCT03252353 | 11.2 | REQUIRED DOCUMENTS PRIOR TO STUDY INITIATION | 11.2 REQUIRED DOCUMENTS PRIOR TO STUDY INITIATION Prior to the release of study medication to a site, all essential study documents must be collected, reviewed and approved. These may include:  - Appropriate local health authority documentation properly signed and dated by the required Investiga... | [] |
NCT03252353 | 11.3 | STUDY COMPLETION | 11.3 STUDY COMPLETION This study is expected to end when all required patients have been enrolled and the last patient has completed the study and query resolution has been completed. Data and materials that are required before the study can be considered complete and/or terminated are: - Laboratory findings, clinical ... | [] |
NCT03252353 | 11.4 | CLINICAL STUDY REPORT | 11.4 CLINICAL STUDY REPORT A clinical study report will be developed by the Sponsor at completion of data analysis. This report will be a clinical and statistical integrated report, according to the ICH E3 guidelines. | [] |
NCT03252353 | 11.5 | RETENTION OF STUDY RECORDS | 11.5 RETENTION OF STUDY RECORDS The Investigator will retain copies of the approved protocol, completed eCRF, ICFs, relevant source documents, and all other supporting documentation related to the project for as long as specified in ICH GCP1 . in a secure and safe facility with limited access If the Investigator is una... | [] |
NCT03252353 | 11.6 | CONFIDENTIALITY AND PUBLICATION OF STUDY DATA | 11.6 CONFIDENTIALITY AND PUBLICATION OF STUDY DATA All information supplied by Chiasma in association with this study and not previously published, is considered confidential information. This information includes, but is not limited to, the Investigator's Brochure, the protocol, eCRFs, and other scientific data. Any d... | [] |
NCT03252353 | 12 | REFERENCES | 12 REFERENCES - Ben-Shlomo, A. and S. Melmed (2008). "Acromegaly." Endocrinol Metab Clin North Am 37(1): 101-122, viii. - Caron, P., A. Beckers, et al. (2002). "Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in the management of acromegaly." The Journal of clinical endocrinology and meta... | [] |
NCT03252353 | 13 | APPENDICES | 13 APPENDICES | Appendix A | Schedule of Activities 90 | | |------------|-----------------------------------------------------------|--| | Appendix B | Acromegaly and Treatment Directed Physical Examination 93 | | | Appendix C | Declaration of Helsinki (2013) 94 | | 
Appendix A Schedule of Acti... | [
"Appendix A Schedule of Activities",
"Appendix B Acromegaly and Treatment Directed Physical Examination",
"Appendix C Declaration of Helsinki (2013)",
"Preamble",
"General Principles",
"Research Ethics Committees",
"Privacy and Confidentiality",
"Informed Consent",
"Use of Placebo",
"Post-Trial Pr... |
NCT03268941 | 1.0 | TRIAL SUMMARY | 1.0 TRIAL SUMMARY | Name of Sponsor: | Compound: | |---------------------------------------------------------------------------------------------|-----------------| | Millennium Pharmaceuticals, Inc. (Takeda Global Research andDevelopment –United States) | TAK-906 maleate | | Study Identifier: TAK-906-1002 | Phase:2a |... | [
"Trial Design:",
"Trial Primary Objective:",
"Trial Secondary Objectives:",
"Main Criteria for Inclusion:",
"Main Criteria for Exclusion:",
"Main Criteria for Evaluation and Analyses:",
"Statistical Considerations:",
"Sample Size Justification:"
] |
NCT03268941 | 1.1 | Protocol Amendment No. 04 Summary of Changes | 1.1 Protocol Amendment No. 04 Summary of Changes
Rationale for Amendment 04 This document describes the changes in reference to the protocol incorporating Amendment No. 04. The primary reason for this amendment is to correct and clarify errors and omissions. Minor grammatical, editorial, and formatting changes are inc... | [
"Rationale for Amendment 04",
"Changes in Amendment 04:"
] |
NCT03268941 | 2.0 | STUDY SCHEMATIC | 2.0 STUDY SCHEMATIC     QD=once daily. | [] |
NCT03268941 | 3.0 | SCHEDULE OF STUDY PROCEDURES | 3.0 SCHEDULE OF STUDY PROCEDURES | | | | | | | | | Part 1 (Treatment Groups A, B, C, and D) | | | | | | | | |------------------------------------------------------------------------------------------------------------------|--------------------------------------|--------|----|----------------------|----------|---|-----... | [
"Part 2"
] |
NCT03268941 | 4.0 | INTRODUCTION | 4.0 INTRODUCTION | [] |
NCT03268941 | 4.1 | Background | 4.1 Background The overall program strategy is to develop TAK-906 for patients with gastroparesis (GP), a disorder of the stomach characterized by delayed gastric emptying (GE) in the absence of mechanical obstruction. Symptoms are chronic with episodic symptom exacerbation [\[1\]](#page-71-9). These symptoms may inclu... | [] |
NCT03268941 | 4.2 | Rationale for the Proposed Trial | 4.2 Rationale for the Proposed Trial There are approximately 13 million patients with GP in United States, European Union, and Japan. The most common causes are idiopathic (~36%) and diabetes (~29%). TAK-906 is a D2/D3 DA antagonist belonging to a class of prokinetic drugs (eg, domperidone and metoclopramide) shown to ... | [] |
NCT03268941 | 4.3 | Benefit/Risk Profile | 4.3 Benefit/Risk Profile There is no expected clinical benefit to the trial participants. In vitro, TAK-906 showed no potential for cytochrome P-450 (CYP) enzyme inhibition (2C9, 2C19, and 3A4) or induction (3A4). To date, no drug-drug interaction data are available for hormonal contraceptive use during TAK-906 adminis... | [] |
NCT03268941 | 5.0 | TRIAL OBJECTIVES AND ENDPOINTS | 5.0 TRIAL OBJECTIVES AND ENDPOINTS | [] |
NCT03268941 | 5.1 | Hypotheses | 5.1 Hypotheses - ! Multiple twice daily (BID) administration of TAK-906 maleate in subjects with GP will be safe and well tolerated, based on an assessment of clinical and laboratory adverse events (AEs), to permit continued clinical investigation. - ! Following the first dose, 1 or more well-tolerated doses of TAK-906... | [] |
NCT03268941 | 5.2 | Trial Objectives | 5.2 Trial Objectives | [] |
NCT03268941 | 5.2.1 | Trial Primary Objective | 5.2.1 Trial Primary Objective The primary objective of the study is: ! To evaluate the safety and tolerability of TAK-906 in subjects with GP. | [] |
NCT03268941 | 5.2.2 | Trial Secondary Objectives | 5.2.2 Trial Secondary Objectives The secondary objective(s) of the study are: - ! To assess the prolactin PK/PD relationship in subjects with GP. - ! To demonstrate the effect of TAK-906 on GEBT. | [] |
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