protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03357471 | 10.6 | Safety signal detection | 10.6 Safety signal detection Selected data from this study will be reviewed periodically to detect as early as possible any safety concern(s) related to the IMP or investigational device so that Investigators, clinical study subjects, regulatory authorities, and IRBs/IECs will be informed appropriately and as early as ... | [] |
NCT03357471 | 10.7 | Laboratory measurements | 10.7 Laboratory measurements For women of childbearing potential, a urine pregnancy test will be performed at Visit 1 and Visit 2. A serum pregnancy test will be performed in the event of a positive urine result. Confidential Page 41 of 82 | [] |
NCT03357471 | 10.8 | Other safety measurements | 10.8 Other safety measurements | [] |
NCT03357471 | 10.8.1 | Vital signs | 10.8.1 Vital signs Vital signs will include systolic and diastolic BP, pulse, RR, and body temperature. Subjects should be supine for 5 minutes before and during the collection of BP and pulse measurements. Vital signs will be measured at Visit 1 and Visit 2. | [] |
NCT03357471 | 10.8.2 | Physical examination | 10.8.2 Physical examination The physical examination will include general appearance; ear, nose, and throat; eyes, hair, and skin; respiratory; cardiovascular; gastrointestinal; musculoskeletal; hepatic; neurological (including limb reflexes); and mental status. Height and weight will also be measured. The physical exa... | [] |
NCT03357471 | 11 | STUDY MANAGEMENT AND ADMINISTRATION INISTRATION | 11 STUDY MANAGEMENT AND ADMINISTRATION INISTRATION | [] |
NCT03357471 | 11.1 | Adherence to protocol | 11.1 Adherence to protocol The Investigator should not deviate from the protocol. However, the Investigator should take any measure necessary in deviation from or not defined by the protocol in order to protect clinical study subjects from any immediate hazard to their health and safety. In this case, this action shoul... | [] |
NCT03357471 | 11.2 | Monitoring | 11.2 Monitoring UCB (or designee) will monitor the study to meet the Sponsor's monitoring Standard Operating Procedures (SOPs), ICH-GCP guideline, and applicable regulatory requirements, and to ensure that study initiation, conduct, and closure are adequate. Monitoring of the study may be delegated by UCB to a CRO or a... | [] |
NCT03357471 | 11.2.1 | Definition of source data | 11.2.1 Definition of source data All source documents must be accurate, clear, unambiguous, permanent, and capable of being audited. They should be made using some permanent form of recording (ink, typing, printing, optical disc). They should not be obscured by correction fluid or have temporary attachments (such as re... | [] |
NCT03357471 | 11.2.2 | Source data verification | 11.2.2 Source data verification Source data verification ensures accuracy and credibility of the data obtained. During monitoring visits, reported data are reviewed with regard to being accurate, complete, and verifiable from source documents (eg, subject files, recordings from automated instruments, tracings [ECG], x-... | [] |
NCT03357471 | 11.3 | Data handling | 11.3 Data handling | [] |
NCT03357471 | 11.3.1 | Case Report form completion | 11.3.1 Case Report form completion The Investigator is responsible for prompt reporting of accurate, complete, and legible data in the eCRFs and in all required reports. Any change or correction to the eCRF after saving must be accompanied by a reason for the change. eCR Corrections made after the Investigator's review... | [] |
NCT03357471 | 11.3.2 | Database entry and reconciliation 11.3.2 | 11.3.2 Database entry and reconciliation 11.3.2 Case Report forms/external electronic data will be entered/loaded into a validated electronic database using a clinical data management system (CDMS). Computerized data cleaning checks will be used in addition to manual review to check for discrepancies and to ensure cons... | [] |
NCT03357471 | 11.3.3 | Subject Screening and Enrollment log/Subject Identification Code list | 11.3.3 Subject Screening and Enrollment log/Subject Identification Code list The subject's screening and enrollment will be recorded in the Subject Screening and Enrollment log. The Investigator will keep a Subject Identification Code list. This list remains with the Investigator and is used for unambiguous identificat... | [] |
NCT03357471 | 11.4 | Termination of the study | 11.4 Termination of the study UCB reserves the right to temporarily suspend or prematurely discontinue this study either at a single site, multiple sites, or at all sites at any time for reasons including, but not limited to, safety or ethical issues, inaccurate or incomplete data recording, noncompliance, or unsatisfa... | [] |
NCT03357471 | 11.5 | Archiving and data retention | 11.5 Archiving and data retention The Investigator will maintain adequate records for the study, including CRFs, medical records, laboratory results, Informed Consent documents, drug dispensing and disposition records, safety reports, information regarding participants who discontinued, and other pertinent data. nforme... | [] |
NCT03357471 | 11.6 | Audit and inspection | 11.6 Audit and inspection The Investigator will permit study-related audits mandated by UCB, after reasonable notice, and inspections by domestic or foreign regulatory authorities. The main purposes of an audit or inspection are to confirm that the rights and well-being of the subjects enrolled have been protected, tha... | [] |
NCT03357471 | 11.7 | Good Clinical Practice | 11.7 Good Clinical Practice Noncompliance with the protocol, ICH-GCP, or local regulatory requirements by the Investigator, institution, institution staff, or designees of the Sponsor will lead to prompt action by UCB to secure compliance. Continued noncompliance may result in the termination of the site's involvement ... | [] |
NCT03357471 | 12 | STATISTICS | 12 STATISTICS A description of statistical methods follows and will be described in more detail in the Statistical Analysis Plan. | [] |
NCT03357471 | 12.1 | Definition of analysis sets | 12.1 Definition of analysis sets The Safety Set (SS) will consist of all subjects of the study who have received at least 1 dose of CZP during the study (e-Device). REDACTED COPY y zed Safety Safety variables will be analyzed using the Safety Set (SS). The Full Analysis Set (FAS) will consist of all subjects in the SS ... | [] |
NCT03357471 | 12.2 | General statistical considerations statistical | 12.2 General statistical considerations statistical This is an estimation study design with no formal statistical hypothesis testing. The study will estimate the true population proportion and/or mean. Each endpoint will be summarized by dosing regimen (Q2W or Q4W) and by indication. hy by by Summary statistics for con... | [] |
NCT03357471 | 12.3 | Planned analyses | 12.3 Planned analyses All statistical analyses will be descriptive in nature. No inferential statistical analyses are planned. | [] |
NCT03357471 | 12.3.1 | Analysis of the primary outcome variable | 12.3.1 Analysis of the primary outcome variable The primary outcome variable is the proportion (%) of all subjects able to self-administer safe and effective injections using the e-Device at Visit 2. Safe and effective self-injection will be evaluated by the HCP and is defined as: -injection injected b - Complete Dose ... | [] |
NCT03357471 | 12.3.2 | Analyses of secondary outcome variables ses | 12.3.2 Analyses of secondary outcome variables ses The secondary outcome variables include: - The proportion (%) of subjects able to self-administer safe and effective injections using the e-Device at Visit 1. Safe and effective self-injection will be evaluated by the HCP and is defined as: self . self- - Complete Dose... | [] |
NCT03357471 | 12.3.3 | Analyses of other outcome variables | 12.3.3 Analyses of other outcome variables Other outcome variables are: - Injection site pain due to self-injection (using a Visual Analog Scale [VAS]; 100mm) by visit at all visits after self-injection using the e-Device - Responses to the preinjection ASI at Visit 1 - Responses to the postinjection ASI by visit at al... | [] |
NCT03357471 | 12.4 | Planned safety analyses | 12.4 Planned safety analyses | [] |
NCT03357471 | 12.4.1 | Safety analyses | 12.4.1 Safety analyses Safety endpoints include AEs and changes from baseline in vital signs. Analyses of the safety data will be done on the SS. REDACTED COPY s safet All summaries of continuous safety variables will be presented at scheduled time points. No statistical testing will be conducted on the safety paramete... | [] |
NCT03357471 | 12.5 | Handling of protocol deviations | 12.5 Handling of protocol deviations Important protocol deviations are deviations from the protocol which potentially could have a meaningful impact on the primary objective of the study. The criteria for identifying important protocol deviations and the classification of important protocol deviations will be defined w... | [] |
NCT03357471 | 12.6 | Handling of dropouts or missing data | 12.6 Handling of dropouts or missing data There will be no special procedures for handling missing data. All imputation of missing or partial dates for safety assessments will be detailed in the Statistical Analysis Plan. | [] |
NCT03357471 | 12.7 | Planned interim analysis and data monitoring sis | 12.7 Planned interim analysis and data monitoring sis No interim analysis is planned. There will be no Data Monitoring Committee established for this study. study | [] |
NCT03357471 | 12.8 | Determination of sample size | 12.8 Determination of sample size This study will not be powered with respect to any endpoint and sample size is based on practical considerations. The number of subjects and their diagnosed conditions are summarized below. Approximately 80 subjects who are currently being treated with commercial CZP and are on a stabl... | [] |
NCT03357471 | 13 | ETHICS AND REGULATORY REQUIREMENTS A | 13 ETHICS AND REGULATORY REQUIREMENTS A | [] |
NCT03357471 | 13.1 | Informed consent | 13.1 Informed consent Subject's informed consent must be obtained and documented in accordance with local regulations, ICH-GCP requirements, and the ethical principles that have their origin in the principles of the Declaration of Helsinki. ICH Prior to obtaining informed consent, information should be given in a langu... | [] |
NCT03357471 | 13.2 | Subject identification cards | 13.2 Subject identification cards Upon signing the Informed Consent form, the subject will be provided with a subject identification card in the language of the subject. The Investigator will fill in the subject identifying information and medical emergency contact information. The Investigator will instruct the subjec... | [] |
NCT03357471 | 13.3 | Institutional Review Boards and Independent Ethics Committees | 13.3 Institutional Review Boards and Independent Ethics Committees The study will be conducted under the auspices of an IRB/IEC, as defined in local regulations, ICH-GCP, and in accordance with the ethical principles that have their origin in the Declaration of Helsinki. REDACTED COPY I The Investigator/UCB will ensure... | [] |
NCT03357471 | 13.4 | Subject privacy | 13.4 Subject privacy UCB staff (or designee) will affirm and uphold the subject's confidentiality. Throughout this study, all data forwarded to UCB (or designee) will be identified only by the subject number assigned at Screening. The Investigator agrees that representatives of UCB, its designee, representatives of the... | [] |
NCT03357471 | 13.5 | Protocol amendments | 13.5 Protocol amendments Protocol changes may affect the legal and ethical status of the study and may also affect the statistical evaluations of sample size and the likelihood of the study fulfilling its primary objective. study Significant changes to the protocol will only be made as an amendment to the protocol and ... | [] |
NCT03357471 | 14 | FINANCE, INSURANCE, AND PUBLICATION | 14 FINANCE, INSURANCE, AND PUBLICATION Insurance coverage will be handled according to local requirements. Finance, insurance, and publication rights are addressed in the Investigator and/or CRO agreements, as applicable. | [] |
NCT03357471 | 15 | REFERENCES | 15 REFERENCES CPMP/ICH/135/95 Note for guidance on Good Clinical Practice (EMEA) Jul 2002. CPMP/I Durmus D, Uzuner B, Durmaz Y, Bilgici A, Kuru O. Michigan Hand Outcomes Questionnaire in rheumatoid arthritis patients: relationship with disease activity, quality of life, and handgrip strength. J Back Musculoskelet Rehab... | [] |
NCT03357471 | 16 | APPENDICES | 16 APPENDICES | [] |
NCT03357471 | 16.1 | Injection Site Pain (VAS) | 16.1 Injection Site Pain (VAS) This scale should be completed immediately postinjection (within 15 minutes). Injection site pain due to self-injection immediately (within 15 minutes) after injection  REDACTED COPY Confidential Page 52 of 82 | [] |
NCT03357471 | 16.2 | Assessment of Self Injection | 16.2 Assessment of Self Injection The ASI comprises 2 modules, the PRE-self-injection and the POST-self-injection modules. The PRE-self-injection module should be administered before subjects start their first self-injection in this study. The POST-self-injection module should be administered within 30 minutes after ea... | [
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"SELF-CONFIDENCE",
"Assessment of Self-Injection (ASI) [and draft new items] POST-Self-Injection",
"Introduction",
"FEELINGS ABOUT INJECTIONS",
"SELF-IMAGE",
"SE... |
NCT03357471 | 16.3 | Self-Injection Preference Questionnaire SELF-INJECTION PREFERENCE QUESTIONNAIRE | 16.3 Self-Injection Preference Questionnaire SELF-INJECTION PREFERENCE QUESTIONNAIRE | ava® | your latest device1 | no preference | |------|---------------------|---------------| | 1 | 2 | 3 | | | The following questions concern your preferences aboutinjections. | | |---------------------------|------------------------... | [] |
NCT03357471 | 16.4 | Cochin Scale | 16.4 Cochin Scale | | | | thereof. | |---------------|----------------------------------------|-------------|---------------| | | | | | | | | | or variations | | | | | | | | | and any | extensions | | | OPYC | application | | | | authorizationREDACTEDmarketing | | | | support any | | | | | used tobe | | | | | ment cann... | [] |
NCT03357471 | 16.5 | Protocol Amendment 1 | 16.5 Protocol Amendment 1
Rationale for the amendment The purpose of this protocol amendment is to clarify subjects in the Q4W dosing regimen, the process of self-injection, and informed consent. In additions, minor grammatical and typographical errors were corrected.
Modifications and changes
Global changes The fol... | [
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"The following paragraph has been added:",
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"Section 4.1.1 Primary outcome and variable, after first bullet",
"The following para... |
NCT03357471 | 16.6 | Protocol Amendment 2 | 16.6 Protocol Amendment 2
Rationale for the amendment The purpose of this protocol amendment is to clarify the composition of subjects in the sample size.
Modifications and changes
Specific changes
Change #1
Section 1 Summary, last paragraph, last sentence These 60 subjects will be composed of a minimum of 15 subj... | [
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"Has been changes to:",
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"Change #3",
"Secti... |
NCT03357471 | 17 | DECLARATION AND SIGNATURE OF INVESTIGATOR | 17 DECLARATION AND SIGNATURE OF INVESTIGATOR I confirm that I have carefully read and understood this protocol and agree to conduct this clinical study as outlined in this protocol, according to current Good Clinical Practice and local laws and requirements. | or variationsI will ensure that all subinvestigators and ot... | [] |
NCT03357471 | 18 | SPONSOR DECLARATION | 18 SPONSOR DECLARATION I confirm that I have carefully read and understand this protocol and agree to conduct this clinical study as outlined in this protocol and according to current Good Clinical Practice. This document cannot be used to support any marketing authorization application and any extensions or variations... | [
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NCT03372161 | 2 | STUDY OBJECTIVES | 2 STUDY OBJECTIVES | [] |
NCT03372161 | 2.1 | Primary Objective | 2.1 Primary Objective The primary objective of this study is to: • Evaluate the analgesic effect on average leg pain (as measured by the NPRS in the affected leg) (Appendix E) following a single TF injection of SP-102 compared to an of placebo over 4 weeks. | [] |
NCT03372161 | 2.2 | Secondary Objectives | 2.2 Secondary Objectives The secondary objectives of the study are to: - Evaluate degree of disability over time as measured by the Oswestry Disability Index (ODI) (Appendix F). - Characterize the change of the subject's radiculopathy symptoms and overall condition using PainDETECT (Appendix G), Brief Pain Inventory – ... | [] |
NCT03372161 | 3.3.3 | Stopping Rules | 3.3.3 Stopping Rules A single occurrence of an adverse event of special interest (AESI) precludes the subject receiving a repeat injection. Three occurrences of the AESI of the same type across the study will trigger stopping of all further dosing until implementation of a safety review. | [] |
NCT03372161 | 3.3.4 | Removal of Subjects from Therapy or Assessment | 3.3.4 Removal of Subjects from Therapy or Assessment A subject will be considered to have completed the study when he or she completes the W24 (D169) visit. If a subject is discontinued at any time after randomization into the study, the investigator will make every effort to follow the subject and complete the End of ... | [] |
NCT03372161 | 3.4 | Treatments | 3.4 Treatments | [] |
NCT03372161 | 3.4.1 | Details of Study Treatments | 3.4.1 Details of Study Treatments Information about the IPs is provided in Table 3.1. Confidential Page 37 of 164        | [] |
NCT03372161 | 3.5 | Assessments | 3.5 Assessments Unless otherwise indicated, all assessments will be performed by the investigator or designated study personnel and captured into eCRFs. | [] |
NCT03372161 | 3.5.1 | Schedule of Assessments | 3.5.1 Schedule of Assessments The procedures to be performed throughout the study are outlined in the Schedule of Assessments (Table 3.2). A detailed description of each assessment may be found in Section 3.5.2. Confidential Page 43 of 164  Confidential Page 44 of 164  Co... | [] |
NCT03372161 | 3.5.6.2 | Oswestry Disability Index | 3.5.6.2 Oswestry Disability Index The ODI (Appendix F) is a validated questionnaire that was first published in 1980 but it was updated in 2000 (Fairbank-1980, Fairbank-2000). The ODI is currently the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. The ODI... | [] |
NCT03372161 | 3.5.6.3 | PainDETECT | 3.5.6.3 PainDETECT PainDETECT (Appendix G) is a 7-question validated tool to determine the prevalence of neuropathic pain in individuals with lower back pain. The 7 responses are summed for a possible score ranging from 0-35. In addition to the 7 questions, subjects note the course of pain (Persistent pain with slight ... | [] |
NCT03372161 | 3.5.6.1 | Brief Pain Inventory - Short Form | 3.5.6.1 Brief Pain Inventory - Short Form The BPI-SF (Appendix H) is a 15-item self-rating scale assessing use of medications, as well as sensory, and reactive components of pain. The BPI-SF includes items that will address components of sensory pain, including severity, location, chronicity, and degree of relief due t... | [] |
NCT03372161 | 3.5.6.2 | Clinical and Patient Global Impression Scales | 3.5.6.2 Clinical and Patient Global Impression Scales The CGIS (Appendix I) is rated on an 8-point scale, with responses ranging of responses from 0 (not assessed) and 1 (normal) through 7 (amongst the most severely ill subjects) (to be completed prior to IP administration at the Baseline (D1) Visit). The CGIC (Appendi... | [] |
NCT03372161 | 3.5.7 | Safety Assessments | 3.5.7 Safety Assessments | [] |
NCT03372161 | 3.5.7.1 | Physical Examination: | 3.5.7.1 Physical Examination: A complete physical examination, including examination of general appearance, skin, neck, eyes, ears, nose, throat, heart, lungs, abdomen, lymph nodes, extremities, and musculoskeletal system, will be performed at Screening. Specific musculoskeletal examination focusing on lumbar spine and... | [] |
NCT03372161 | 3.5.7.2 | General Neurological and Targeted Neurological Examinations: | 3.5.7.2 General Neurological and Targeted Neurological Examinations: A general neurological examination will include evaluation of mental status (awareness of person, place, and time), cranial nerves, motor function and balance, sensory exam (ability to feel) and reflexes. A targeted neurological examination demonstrat... | [] |
NCT03372161 | 3.5.7.3 | Vital Signs and Body Weight: | 3.5.7.3 Vital Signs and Body Weight: Vital signs will include systolic and diastolic BP and heart rate. During the usual clinic visits, the subject is to be seated for approximately 3 mins before vital signs are recorded. During the injection procedure, the vital signs will need to be collected while the subject is in ... | [] |
NCT03372161 | 3.5.7.4 | Electrocardiogram: | 3.5.7.4 Electrocardiogram: Standard 12-lead ECGs will be measured on the site machines at Screening. The ECG results will be documented in the eCRF. Confidential Page 60 of 164  | [] |
NCT03372161 | 3.5.8 | Other Assessments | 3.5.8 Other Assessments Pain Catastrophizing Scale: PCS (Appendix K) is used to assess pain as a baseline characteristic only at Screening (Sullivan-1995). It was developed to quantify a subject's pain experience by asking how they feel and what they think about when they are in pain. Items on this scale were developed... | [] |
NCT03372161 | 3.5.9 | Appropriateness of Measurements | 3.5.9 Appropriateness of Measurements All assessments to be used in this study are commonly used, standard measurements frequently seen in radiculopathy studies. Confidential Page 62 of 164 | [] |
NCT03372161 | 4 | ADVERSE EVENT REPORTING | 4 ADVERSE EVENT REPORTING Throughout the course of the study, after signing the ICF, all AEs will be monitored and recorded on an AE eCRF, including the AE's description, start and end date, seriousness, severity, action taken, and relationship to the IP. If AEs occur, the first concern will be the safety of the study ... | [] |
NCT03372161 | 4.1 | Definitions and Criteria | 4.1 Definitions and Criteria | [] |
NCT03372161 | 4.1.1 | Adverse Events | 4.1.1 Adverse Events An AE is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment (ICH-E2A-1996). An AE can therefore be any unfavorable and unintended sign (including a... | [] |
NCT03372161 | 4.1.2 | Serious Adverse Events | 4.1.2 Serious Adverse Events A serious adverse event (SAE) or reaction is any untoward medical occurrence that at any dose: - Results in death - Is life-threatening - Requires inpatient hospitalization or prolongation of existing hospitalization - Results in persistent or significant disability or incapacity - Is a con... | [] |
NCT03372161 | 4.1.3 | Unexpected Adverse Drug Reactions | 4.1.3 Unexpected Adverse Drug Reactions An unexpected adverse drug reaction (ADR) is a reaction for which the nature or severity is not consistent with the applicable product information (IB, SP102-IB-2015). Until product information is amended, expedited reporting is required for additional occurrences of the reaction... | [] |
NCT03372161 | 4.1.4 | Abnormal Laboratory Values | 4.1.4 Abnormal Laboratory Values Any abnormality (Appendix N) in a laboratory value that is new in onset or which has worsened in severity or frequency from the baseline condition and meets 1 of the following criteria will be recorded on the AE pages of the eCRF: - Requires therapeutic intervention or diagnostic tests ... | [] |
NCT03372161 | 4.1.5 | Assessing Intensity and Relationship | 4.1.5 Assessing Intensity and Relationship All AEs will be assessed on 2 descriptive parameters: intensity and relationship to the IP: - Intensity refers to the severity of an event and references impact on a subject's functioning. - Relationship refers to the likelihood that the event being assessed was caused by the ... | [
"Intensity",
"Relationship"
] |
NCT03372161 | 4.2 | Reporting Procedures and Requirements | 4.2 Reporting Procedures and Requirements | [] |
NCT03372161 | 4.2.1 | Adverse Events | 4.2.1 Adverse Events AEs occurring after the subject signs the ICF until the 30 days after the last study visit will be recorded. Any AEs occurring before the start of treatment (ie, before the first dose of the IP)" will be recorded in the medical history. Also, the sign, symptom, or disease present before starting th... | [] |
NCT03372161 | 4.3 | Procedures for Documenting Pregnancy during the Study | 4.3 Procedures for Documenting Pregnancy during the Study Pregnancy occurring in a female subject should be reported to within 24 hours of becoming aware of the event using the pregnancy eCRF. The investigator will also: (1) notify the subject's physician that the subject may have been treated with SP-102 and (2) follo... | [] |
NCT03372161 | 5.2.9.2 | Electrocardiographic Data | 5.2.9.2 Electrocardiographic Data A listing of 12-lead ECG parameter results obtained at Screening will be presented. | [] |
NCT03372161 | 5.2.9.3 | Laboratory Data | 5.2.9.3 Laboratory Data Mean changes from Baseline (D1) at each post-baseline time point for each laboratory variable will be presented. In addition, each reading will be classified as below, within, or above normal range, based on ranges supplied by the laboratory used. Shift tables for the baseline and follow-up meas... | [] |
NCT03372161 | 5.2.9.4 | Vital Signs | 5.2.9.4 Vital Signs Summary statistics for the absolute vital sign value and the changes from baseline will be presented by treatment group for each visit, for each of the following vital signs: - Systolic blood pressure (mmHg) - Diastolic blood pressure (mmHg) - Heart rate (bpm) Vital sign values will be categorized i... | [] |
NCT03372161 | 5.2.9.5 | Neurological Examinations | 5.2.9.5 Neurological Examinations General neurological and targeted neurological examination results will be summarized descriptively over time and included in listings. | [] |
NCT03372161 | 5.2.10 | Interim Analyses | 5.2.10 Interim Analyses No interim analysis is planned for this study. Note that the study will be unblinded and the primary analysis will be completed after all subjects complete the 12-week assessments and data are cleaned. Subjects in the OL safety extension portion of the study will continue through W24. No efficac... | [] |
NCT03372161 | 6 | STUDY MANAGEMENT | 6 STUDY MANAGEMENT | [] |
NCT03372161 | 6.1 | Ethics and Consent | 6.1 Ethics and Consent | [] |
NCT03372161 | 6.1.1 | Regulations and Guidelines | 6.1.1 Regulations and Guidelines The study will be performed in accordance with this protocol, US investigational new drug (IND) regulations (21 CFR 312), ICH guidelines for Good Clinical Practice (GCP), the regulations on electronic records and electronic signature (21 CFR 11), and the most recent guidelines of the De... | [] |
NCT03372161 | 6.1.2 | Institutional Review Board/Independent Ethics Committees | 6.1.2 Institutional Review Board/Independent Ethics Committees Conduct of the study must be approved by an appropriately constituted institutional review board (IRB). Approval is required for the study protocol, protocol amendments, ICFs, subject information sheets, and advertising materials. No IP will be shipped to a... | [] |
NCT03372161 | 6.1.3 | Informed Consent | 6.1.3 Informed Consent For each trial subject, a written ICF will be obtained before any protocol-related activities. As part of this procedure, the investigator or a designated representative must explain orally and in writing the nature, duration, and purpose of the study, and the action of the IP in such a manner th... | [] |
NCT03372161 | 6.2 | Discontinuation of the Study by the Sponsor | 6.2 Discontinuation of the Study by the Sponsor The sponsor reserves the right to discontinue the study at this site or at multiple sites for safety or administrative reasons at any time. A site that does not recruit at a reasonable rate may be discontinued. Should the study be terminated, and/or the site closed for wh... | [] |
NCT03372161 | 6.3 | Study Documentation | 6.3 Study Documentation By signing a copy of Form FDA 1572, the principal investigator acknowledges that he/she has received a copy of the IB on SP-102 and assures the sponsor that he/she will comply with the protocol and the provisions stated in Form FDA 1572. No changes in this protocol can be made without the sponso... | [] |
NCT03372161 | 6.4 | Study Monitoring and Auditing | 6.4 Study Monitoring and Auditing This study will be monitored for quality assurance at all stages of its development by the clinical research personnel employed by the sponsor or its representative. Monitoring will include personal visits and telephone communication to assure that the investigation is conducted per th... | [] |
NCT03378778 | 1 | Background & Rationale | 1. Background & Rationale Enlargement and shaping of the root canal space are the main objectives of root canal treatment, then sealing it in 3 dimensions to avoid any infection in the future [\[1,](#page-13-0) [2\]](#page-13-1). Wide range of instruments and techniques have been used to accomplish root canal treatment... | [] |
NCT03378778 | 2 | Trial Objectives, Design and Statistics | 2. Trial Objectives, Design and Statistics | [] |
NCT03378778 | 2.1 | Trial Objectives | 2.1. Trial Objectives
Aims and Objectives: The clinical trial aims to investigate whether varying amounts of residual tooth structure have an influence on the success and survival rate of endodontically treated teeth and/or restoration at 1-2 years post treatment by using Cone Beam Computed Tomography (CBCT).
Primary... | [
"Aims and Objectives:",
"Primary and Secondary endpoints:"
] |
NCT03378778 | 2.2 | Trial Design & Flowchart | 2.2 Trial Design & Flowchart The study is a case control comparing the success and survival rate of endodontically treated teeth with varying degrees of tooth structure loss restored using CAD CAM restorations. Patients requiring endodontic treatment will be assessed clinically and radiographically and divided into gro... | [] |
NCT03378778 | 2.3 | Trial Flowchart:- | 2.3 Trial Flowchart:-
STUDY FLOWCHART  | [
"STUDY FLOWCHART"
] |
NCT03378778 | 2.4 | Trial Statistics | 2.4 Trial Statistics | [] |
NCT03378778 | 2.4.1 | Sample Size | 2.4.1 Sample Size The sample size calculation for this study was based on chi-test for testing the association between tooth surface lost (66%) and Root Canal Treatment status (Success or Failure). A study with an effect size of 0.3 and a power of 80% will require a total sample of 108 to test the association at 5% lev... | [] |
NCT03378778 | 2.4.2 | Recruitment and Retention | 2.4.2 Recruitment and Retention Patients who have been referred to the Endodontic Postgraduate Unit or assessment clinics at King's College Dental Institute at Guy's Hospital for root canal treatment will first undergo an examination at the assessment clinic to diagnose and treatment plan their problem by the postgradu... | [] |
NCT03378778 | 2.4.3 | Randomisation | 2.4.3 Randomisation Randomisation is not applicable, as the patients will be divided according to the number of tooth structure lost. | [] |
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