protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT02432846 | 10.5.4 | Vital Signs | 10.5.4 Vital Signs Vital signs will be monitored throughout the study as safety variables at the time points described in Section 7.2.1 and in Table 2. In connection with vaccination and the 4-hour post-vaccination observation period, a detailed monitoring schedule applies, Table 3. The following assessments will be do... | [] |
NCT02432846 | 10.5.5 | Laboratory Safety Assessments (Blood and Urine) | 10.5.5 Laboratory Safety Assessments (Blood and Urine) Blood and urine samples collected should be labelled with the patient's unique screening number at all study visits. The study specific Laboratory Manual, which will be provided to all sites participating in this study, will include full details on blood sample col... | [
"BLOOD",
"URINE"
] |
NCT02432846 | 10.5.6 | Other Safety Measurements | 10.5.6 Other Safety Measurements | [] |
NCT02432846 | 10.5.6.1 | Autoimmunization | 10.5.6.1 Autoimmunization Blood samples will be taken from patients randomized to Intuvax at Vacc1 (prior to vaccination) and Sun-Start Visits to evaluate potential autoimmune events by screening of autoantibodies against clinically relevant autoantigens: • Anti-nuclear antibodies (IF-ANA) and kidney parenchyma-associa... | [] |
NCT02432846 | 10.5.6.2 | Alloimmunization | 10.5.6.2 Alloimmunization Blood samples will be taken from patients randomized to Intuvax at Vacc1 (prior to vaccination) and Sun-Start Visits to evaluate potential vaccine-induced alloimmunization at the humoral level by screening of alloantibodies against HLA-A, B, C (HLA class I) and HLA-DR, DQ, DP (HLA class II) an... | [] |
NCT02432846 | 10.6 | Appropriateness of Measurements | 10.6 Appropriateness of Measurements Standardized methods for measurements of efficacy and safety variables will be used. Confidential Page 63 of 87 Date: 12 February 2019 EudraCT No.: 2014-004510-28 Clinical Study Protocol Sponsor: Immunicum AB (publ) Version: Final 9.0 Study Code: IM-201 | [] |
NCT02432846 | 11 | ADVERSE EVENTS | 11 ADVERSE EVENTS | [] |
NCT02432846 | 11.1 | Definitions | 11.1 Definitions | [] |
NCT02432846 | 11.1.1 | Adverse Event | 11.1.1 Adverse Event Any untoward medical occurrence in a patient or clinical trial patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Comment: An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), sym... | [] |
NCT02432846 | 11.1.2 | Adverse Reaction | 11.1.2 Adverse Reaction All untoward and unintended responses to an IMP related to any dose administered. Comment: All AEs judged by either the reporting Investigator or the Sponsor as having a reasonable causal relationship to a medicinal product qualify as adverse reactions. The expression reasonable causal relations... | [] |
NCT02432846 | 11.1.3 | Unexpected Adverse Reaction | 11.1.3 Unexpected Adverse Reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. Investigator's Brochure for an unauthorized IMP or SmPC/USPI for an authorized product). Comment: When the outcome of the adverse reaction is not consistent with the ap... | [] |
NCT02432846 | 11.1.4 | Serious Adverse Event | 11.1.4 Serious Adverse Event Any untoward medicinal occurrence or effect that at any dose: - Results in death - Is life-threatening - Requires hospitalization or prolongation of existing hospitalization - Results in persistent or significant disability or incapacity - Is a congenital anomaly or birth defect Comments: L... | [] |
NCT02432846 | 11.2 | Reporting of Adverse Events | 11.2 Reporting of Adverse Events Adverse event reporting and data management will be performed according to the following relevant guidelines: Confidential Page 64 of 87 Version: Final 9.0 Study Code: IM-201 Date: 12 February 2019 EudraCT No.: 2014-004510-28 - Directive 2001/20/EC (European Clinical Trial Directive), -... | [
"Grade 1 (Mild)",
"Grade 2 (Moderate)",
"Grade 3 (Severe or medically significant but not immediately life-threatening)",
"Grade 4 (Life-threatening consequences)",
"Grade 5 (Death related to AE)",
"Causality",
"Probable",
"Possible",
"Unlikely",
"Follow-up of Patients after Adverse Events",
"Ab... |
NCT02432846 | 11.3 | Reporting of Serious Adverse Events | 11.3 Reporting of Serious Adverse Events The Investigator is responsible for ensuring that all SAEs are reported to the Sponsor immediately, but in any event no later than 24 hours of any site staff becoming aware of the event. Initial reports should be followed as soon as possible by detailed written reports. The init... | [
"Follow-up of Post-Study Survival Information",
"SAE REPORTING CONTACT DETAILS"
] |
NCT02432846 | 11.4 | SAE and SUSAR Reporting to CAs, IRBs/IECs, and Investigators | 11.4 SAE and SUSAR Reporting to CAs, IRBs/IECs, and Investigators The Sponsor is responsible for informing all concerned CAs, IRB/IECs, and all clinical study investigators utilizing Intuvax of any individual case reports of SAEs that are determined to be reportable by the Sponsor (i.e. SUSARs). For a SUSAR that is fat... | [] |
NCT02432846 | 11.5 | Dose Limiting Toxicity (DLT) | 11.5 Dose Limiting Toxicity (DLT) The following AEs are classified as DLTs: - Any AE of CTCAE grade 3 or higher (except for fever CTCAE grade 4 as this is an expected sign of immunologic response after vaccination), and assessed as possibly or probably related to Intuvax within the interval between the first vaccinatio... | [] |
NCT02432846 | 11.6 | Precautions/Overdose | 11.6 Precautions/Overdose Preparedness for anaphylaxis treatment in connection with vaccination is required. No antidote for Intuvax is available. In the event of overdose symptomatic management is indicated. | [] |
NCT02432846 | 11.7 | Pregnancy | 11.7 Pregnancy Contraception is to be used from Screening until 90 days after last dose of Intuvax and/or until completed sunitinib treatment whichever occurs later. Female patients will be instructed to notify the Investigator immediately if they become pregnant during the study. Male patients will be instructed to no... | [] |
NCT02432846 | 12 | STATISTICAL METHODS AND DETERMINATION OF SAMPLE SIZE | 12 STATISTICAL METHODS AND DETERMINATION OF SAMPLE SIZE | [] |
NCT02432846 | 12.1 | Statistical and Analytical Plans | 12.1 Statistical and Analytical Plans A separate SAP, which will provide the technical details of the statistical analysis outlined below, will be prepared and approved before study data analysis, including any interim analysis. | [] |
NCT02432846 | 12.1.1 | Data Sets to be Analyzed | 12.1.1 Data Sets to be Analyzed The analysis population sets, which will be defined separately by stratum, are defined as follows: Full analysis set (FAS): All patients randomized being evaluable for any high or intermediate stratum related efficacy endpoint. Per protocol set (PPS): All patients randomized to Intuvax w... | [] |
NCT02432846 | 12.1.2 | Definitions | 12.1.2 Definitions For definitions used for endpoint evaluation, see Section 10.2.1 and Section 10.2.2. | [] |
NCT02432846 | 12.1.3 | Statistical Issues | 12.1.3 Statistical Issues As this study is exploratory, sample size is not based on typical power calculation for confirming an efficacy as this would require either a too long follow-up or an unrealistic number of patients. Statistical hypothesis testing will be used but to be interpreted as exploratory analysis resul... | [] |
NCT02432846 | 12.1.4 | Summary Statistics | 12.1.4 Summary Statistics In general, data will be summarized by means of summary statistics. Continuous data will be presented with the number of observations, mean value, standard deviation, minimum, Q1, median, Q3 and maximum value. Categorical data will be presented as counts and percentages. Visit related data wil... | [] |
NCT02432846 | 12.1.5 | Primary Efficacy Analyses | 12.1.5 Primary Efficacy Analyses Two primary endpoints are defined, each one in relation to the two primary objectives. As this trial is not powered to detect a statistical significant difference between treatment groups, Section 12.2, the statistical analyses described below should be considered exploratory. No adjust... | [
"OS",
"18-month survival rate"
] |
NCT02432846 | 12.1.6 | Secondary Efficacy Analyses | 12.1.6 Secondary Efficacy Analyses Secondary efficacy endpoints will be presented descriptively by stratum (High-/Intermediaterisk mRCC patients) as stated explicitly for each endpoint below. Further analyses may be defined in the SAP, if appropriate. All secondary endpoints will be evaluated using the FAS. In addition... | [
"PFES from start of sunitinib in intermediate and high-risk mRCC patients",
"Response rate from Sunitinib Start Visit",
"Number of infiltrating CD8+ T-cells"
] |
NCT02432846 | 12.1.8 | Pharmacokinetic Analysis - N/A | 12.1.8 Pharmacokinetic Analysis - N/A Version: Final 9.0 Study Code: IM-201 Date: 12 February 2019 EudraCT No.: 2014-004510-28 | [] |
NCT02432846 | 12.1.9 | Demographic and Other Baseline Characteristics | 12.1.9 Demographic and Other Baseline Characteristics A patient disposition will be made including number of patients randomized, exposed to trial drug and completing, or withdrawal from trial (including reason for withdrawal). The number of patients in each analysis set will be included. The patient disposition will b... | [] |
NCT02432846 | 12.1.10 | Exposure to Treatment | 12.1.10 Exposure to Treatment All details collected in relation to the Intuvax vaccination will be listed and tabulated if applicable. Nephrectomy data will be listed. Exposure data for sunitinib use will be listed per treatment group and stratum. | [] |
NCT02432846 | 12.1.11 | Concomitant Treatment | 12.1.11 Concomitant Treatment Concomitant medication and concomitant therapy will be summarized as number of patients being treated with each type of medication/therapy classified according to ATC level 3 and WHO Drug Dictionary preferred term. The safety set will be used for this presentation. | [] |
NCT02432846 | 12.1.12 | Adverse Events | 12.1.12 Adverse Events Analyses of AEs will be based on the Safety set. AEs will be coded using MedDRA. The total number of AEs will be summarized including the number of patients with at least one (1) AE, the total number of AEs, the number of unique AEs per treatment group and in total. The number of AEs per severity... | [] |
NCT02432846 | 12.1.13 | Other Safety Assessments | 12.1.13 Other Safety Assessments
Physical Examination Physical examination data will be summarized by visit and treatment group as described in Section 12.1.4. Confidential Page 73 of 87 Clinical Study Protocol Sponsor: Immunicum AB (publ) Date: 12 February 2019 EudraCT No.: 2014-004510-28
Vital Signs Vital signs wil... | [
"Physical Examination",
"Vital Signs",
"Laboratory Safety Assessments"
] |
NCT02432846 | 12.2 | Determination of Sample Size | 12.2 Determination of Sample Size This is a proof of concept study and the number of patients chosen is based on practical considerations and not on a formal statistical power calculation. With around 90 patients randomized 2:1 to vaccination and control, it is expected that 18-month survival rate for highrisk and inte... | [] |
NCT02432846 | 12.3 | Procedures for Reporting any Deviation(s) from the Original Statistical Analysis Plan | 12.3 Procedures for Reporting any Deviation(s) from the Original Statistical Analysis Plan Any deviation(s) from the original SAP will be described and justified in a protocol amendment and/or in a revised SAP and/or in the final report, as appropriate. | [] |
NCT02432846 | 12.4 | Interim Analysis | 12.4 Interim Analysis An interim analysis is not planned for in this study. | [] |
NCT02432846 | 12.5 | Follow-up Analysis of Post-Study Survival Data | 12.5 Follow-up Analysis of Post-Study Survival Data Survival data will be analyzed post-study end as described in Section 12.1.5 and Section 12.1.6 and presented as addendum(s) to the final study report. Time-point(s) for analysis will be confirmed when considered justified by Immunicum AB and the Coordinating Investig... | [] |
NCT02432846 | 13 | INVESTIGATOR/SPONSOR RESPONSIBILITIES | 13 INVESTIGATOR/SPONSOR RESPONSIBILITIES | [] |
NCT02432846 | 13.1 | Ethics | 13.1 Ethics | [] |
NCT02432846 | 13.1.1 | Institutional Review Boards/Independent Ethics Committees and Competent Authorities | 13.1.1 Institutional Review Boards/Independent Ethics Committees and Competent Authorities This protocol and any amendments will be submitted to concerned competent authorities (CAs) and properly constituted IRBs/IECs, in accordance with the International Conference on Harmonisation (ICH) guidelines, the applicable Eur... | [] |
NCT02432846 | 13.1.2 | Ethical Conduct of the Study | 13.1.2 Ethical Conduct of the Study The study will be conducted in compliance with the protocol, the applicable European Directives, US CFR sections that address clinical research studies, and/or other national and local legal requirements, ICH E6 good clinical practice (GCP) and the ethical principles of the latest re... | [] |
NCT02432846 | 13.1.3 | Patient Information and Consent | 13.1.3 Patient Information and Consent All patients will receive written and verbal information regarding the study at a prior interview. This information will emphasize that participation in the study is voluntary and that the patient may withdraw from the study at any time and for any reason. All patients will be giv... | [] |
NCT02432846 | 13.2 | Patient Records and Source Data | 13.2 Patient Records and Source Data The origin of source data in the study will be further specified for each study site in a separate document ("Origin of Source Data"). Confidential Page 75 of 87 Version: Final 9.0 Study Code: IM-201 Date: 12 February 2019 EudraCT No.: 2014-004510-28 Clinical Study Protocol Sponsor:... | [] |
NCT02432846 | 13.3 | Access to Source Data and Documentation | 13.3 Access to Source Data and Documentation The Investigator should guarantee access to source documents for the monitor and auditors as well as for inspection by appropriate regulatory agencies, and the IRB/IEC, if required. | [] |
NCT02432846 | 13.4 | Monitoring | 13.4 Monitoring Immunicum AB is responsible for selecting qualified clinical trial centers to participate in this clinical trial. Site management and monitoring is delegated to and these activities are specified in detail in the Study Monitoring Manual. The monitor will visit the study site to ensure that the study is ... | [] |
NCT02432846 | 13.5 | Training of Study Personnel | 13.5 Training of Study Personnel The Investigator will maintain records of all individuals involved in the trial (medical, nursing and other personnel) and complete a delegation list to clarify roles and responsibilities. With the support from the designated CRO and Immunicum AB the Investigator will ensure that approp... | [] |
NCT02432846 | 13.6 | Data Management | 13.6 Data Management Data management and handling of data will be conducted according to the study specific Data Management Plan, ICH guidelines and - standard operating procedures (SOPs). the study site personnel. Validation and data queries will be handled by the Data An eCRF system will be used to capture data from ... | [] |
NCT02432846 | 13.7 | Quality Assurance and Audit | 13.7 Quality Assurance and Audit Audits or inspections, including source data verification, may be performed by representatives of[l the Sponsor, a CA and/or an IRB/IEC. | [] |
NCT02432846 | 13.8 | Record Retention | 13.8 Record Retention The Investigator/Institution should maintain essential documents (as defined in ICH E6 GCP, Section 8) as required by the applicable regulatory requirement(s). The Investigator/Institution should take measures to prevent accidental or premature destruction of the documents. Clinical Study Protocol... | [] |
NCT02432846 | 13.9 | Protocol Deviations | 13.9 Protocol Deviations Deviations to the study protocol will be documented in a Protocol Deviation Log. The classification of patients into protocol deviators will be made during a meeting before database lock. The classification will be mutually agreed between the Sponsor and before breaking the randomization codes.... | [] |
NCT02432846 | 13 | 10Protocol Amendments | 13.10Protocol Amendments If the study protocol needs to be substantially amended, the amendment must be approved by the CA and/or the IRB/IEC, as appropriate, before implementation, except for an amendment resulting from an immediate hazard to the patients. Approval must also be obtained for updates to the written Pati... | [] |
NCT02432846 | 13 | 11Insurance | 13.11Insurance The Sponsor must provide insurance or must indemnify (legal and financial coverage) the Investigator/the institution against claims arising from the study, except for claims that arise from malpractice, negligence or non-compliance with the protocol. | [] |
NCT02432846 | 13 | 12Report and Publication | 13.12Report and Publication After completion of the study, a clinical study report will be prepared according to the ICH Guideline for Structure and Content of Clinical Study Reports (ICH E3) by in close collaboration with the Investigator and the Sponsor. Post-study survival data will be amended to the report. All pub... | [] |
NCT02432846 | 14 | REFERENCE LIST | 14 REFERENCE LIST 1. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer. 2009; 45:228-47 - 2. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Published: May 28, 2009 (v4.0... | [
"COORDINATING INVESTIGATOR:",
"PROJECT MANAGER:",
"BIOSTATISTICIAN:",
"STUDY PROTOCOL AUTHOR:",
"PROJECT MANAGER:",
"BIOSTATISTICIAN:",
"STUDY PROTOCOL AUTHOR:"
] |
NCT02432846 | 16 | CLINICAL STUDY PROTOCOL AGREEMENT FORM | 16 CLINICAL STUDY PROTOCOL AGREEMENT FORM | [] |
NCT02432846 | 16.1 | Clinical Study Protocol Agreement Form | 16.1 Clinical Study Protocol Agreement Form I have read the clinical study protocol entitled: "An open-label, randomized, controlled, multicenter, phase II study evaluating safety and efficacy of intratumorally administered Intuvax pre-nephrectomy followed by Sunitinib post-nephrectomy, compared to Sunitinib post-nephr... | [] |
NCT02459795 | 1 | BACKGROUND | 1. BACKGROUND  New York, Inc. has developed a generic formulation of Ingenol Mebutate Topical Gel 0.05%. | [] |
NCT02459795 | 2 | STUDY OBJECTIVES | 2 STUDY OBJECTIVES The objectives of this study are to compare the safety and efficacy profiles of Perrigo New York, Inc.'s Ingenol Mebutate Topical Gel 0.05% to Picato® Topical Gel 0.05% (Ingenol Mebutate Topical Gel 0.05%) and to demonstrate the superior efficacy of the two active formulations over that of the vehicl... | [] |
NCT02459795 | 2.1 | Endpoints | 2.1 Endpoints The primary efficacy endpoint will be the proportion of subjects with clinical response of success defined as complete clearance (absence) of all clinically visible Actinic Keratosis lesions identified at the baseline visit and no new Actinic Keratosis lesions in the selected treatment area at Visit 4/Day... | [] |
NCT02459795 | 2.2 | Safety | 2.2 Safety Safety of the test and reference products will be compared by evaluating the nature, severity and frequency of their adverse event profiles. All adverse events that occur during the study (from the moment a subject signs an informed consent/assent) will be recorded. Descriptions of reactions or complaints wi... | [] |
NCT02459795 | 3 | STUDY DESIGN | 3 STUDY DESIGN | [] |
NCT02459795 | 3.1 | Type/Design of Study | 3.1 Type/Design of Study Subjects in this multi-center, double-blind, randomized, vehicle-controlled, parallel-group study will be assigned to test product, reference product, or vehicle, respectively. The study medication will be dispensed at Visit 1/Day 1 (Baseline) to subjects meeting all entry criteria. The assigne... | [] |
NCT02459795 | 3.2 | Study Population | 3.2 Study Population Healthy male and female subjects, at least 18 years of age, with 4 to 8 clinically typical, visible, discrete Actinic Keratosis lesions within a contiguous 25cm2 treatment area on either the trunk or extremities who meet all eligibility criteria will be enrolled in this multicenter study. | [] |
NCT02459795 | 4 | SELECTION AND WITHDRAWAL OF STUDY SUBJECTS | 4. SELECTION AND WITHDRAWAL OF STUDY SUBJECTS | [] |
NCT02459795 | 4.1 | Inclusion Criteria | 4.1 Inclusion Criteria Subjects must meet all of the following criteria: - 1. Subject must sign an Institutional Review Board (IRB) approved written informed consent/assent for this study. Subjects under the legal age of consent for their respective state must sign an IRB approved written informed consent/assent in add... | [] |
NCT02459795 | 4.2 | Exclusion Criteria | 4.2 Exclusion Criteria Subjects may not be enrolled if any of the following criteria exist: - 1. Subjects who are pregnant, nursing, or planning a pregnancy within the study period. - 2. Subjects who are immunocompromised or HIV positive or who have any immune-system disorders including auto-immune diseases. - 3. Subje... | [] |
NCT02459795 | 4.3 | Medications, Supplements, Other Substances and Procedures Prohibited Before Enrollment and During the Study | 4.3 Medications, Supplements, Other Substances and Procedures Prohibited Before Enrollment and During the Study The medications prohibited prior to enrollment, and required washout period, are listed in Table 4.3.1 with the subject exclusion criteria. Table 4.3.1 Medications, Supplements, and Other Substances Prohibite... | [] |
NCT02459795 | 4.4 | Precautions | 4.4 Precautions The following precautions are to be taken during this study: | 1. | Subjects should wash their hands with mild soap and water before and after applyingstudy medication and should take care not to transfer the study medication to otherbody areas, including the eye. | |-----|------------------------------... | [] |
NCT02459795 | 5 | PROCEDURES | 5. PROCEDURES | [] |
NCT02459795 | 5.1 | Subject Screening and Enrollment | 5.1 Subject Screening and Enrollment The study personnel will review the IRB approved informed consent form and assent form, if applicable, with each subject and give the subject an opportunity to have all questions answered before proceeding. The consent/assent form must be signed by each subject and witnessed before ... | [] |
NCT02459795 | 5.2 | Assignment of Subject Number | 5.2 Assignment of Subject Number Once the subject has consented, met eligibility criteria and is considered enrolled in the study, study staff will assign a subject number to the subject. The subject number will correspond to a computer-generated randomization schedule assigning the number to one of the three study tre... | [] |
NCT02459795 | 5.3 | Demographics/Medical History | 5.3 Demographics/Medical History A demographic profile and complete medical history will be recorded prior to starting study medication. The medical history will include a complete review of all current diseases and their respective treatments. | [] |
NCT02459795 | 5.4 | Concomitant Medications | 5.4 Concomitant Medications Concurrent medications and any medications taken prior to signing informed consent/assent will be recorded as prior/concomitant medications (using their generic name, if known) with the corresponding indication. The medications to be recorded will include prescription (Rx) and over-the-count... | [] |
NCT02459795 | 5.5 | Physical Examination | 5.5 Physical Examination The investigator, sub-investigator or appropriately delegated and qualified designee will perform a brief physical examination prior to the subject starting study medication. | [] |
NCT02459795 | 5.6 | Urine Pregnancy Test | 5.6 Urine Pregnancy Test Females of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 2 years), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study. | [] |
NCT02459795 | 5.7 | Dermatological Assessment (Diagnosis) | 5.7 Dermatological Assessment (Diagnosis) The investigator or sub-investigator will examine the subject to establish the clinical diagnosis of Actinic Keratosis defined as the presence of 4 to 8 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic Actinic Keratosis lesions, contained within a conti... | [] |
NCT02459795 | 5.8 | Fitzpatrick Classification Scale | 5.8 Fitzpatrick Classification Scale The Fitzpatrick skin scale classifies a person's complexion and their tolerance of sunlight. It is commonly used by many practitioners to determine how someone will respond or react to dermatological treatments, and how likely they are to get skin cancer. | | I | | |----|-----------... | [] |
NCT02459795 | 5.9 | Clinical Actinic Keratosis Lesion Counting & Assessment | 5.9 Clinical Actinic Keratosis Lesion Counting & Assessment
Protocol No: PRG-NY-15-002 any shape, to be treated with the study medication gel as the designated treatment area on the trunk or extremities. This selected treatment area should have 4 to 8 visible clinically discrete Actinic Keratosis lesions. Additionally... | [
"Protocol No: PRG-NY-15-002 any shape, to be treated with the study medication gel as the designated treatment area on the trunk or extremities. This selected treatment area should have 4 to 8 visible clinically discrete Actinic Keratosis lesions. Additionally, the PI or designated staff will document the location ... |
NCT02459795 | 5.10 | Application Site Reaction Assessment | 5.10 Application Site Reaction Assessment To the greatest extent possible, the same investigator who made Visit 1/Day 1 (Baseline) assessments will assess the application site reactions, grade them according to a 5-point scale and a designated staff will record them in the source document and eCRFs at each subsequent v... | [] |
NCT02459795 | 5.11 | Study Medication Use, Patient Instructions and Diary | 5.11 Study Medication Use, Patient Instructions and Diary Each subject's drug kit box contains 0.47 gram tubes. At the baseline visit, the subject will apply the contents of one of the tubes at the site under study staff supervision and that tube will be placed back in the drug kit box. The second tube will be given to... | [
"Subjects must not use the study medication for more than 2 consecutive days."
] |
NCT02459795 | 5.12 | Visit Specific Procedures | 5.12 Visit Specific Procedures The following sections outline the procedures required at each visit. | [] |
NCT02459795 | 5.12.1 | Visit 1/Day 1 (Baseline) | 5.12.1 Visit 1/Day 1 (Baseline) Prospective subjects will visit the study center and will be examined by the principal investigator or delegated staff. The following procedures will be performed at the baseline visit:  5.12.2 Visit 2/Day 3 (±1 day) 5.12.3 Follow-up Phone Call /Day 15 (± 3 days) ... | [] |
NCT02459795 | 5.12.6 | Unscheduled | 5.12.6 Unscheduled Protocol No: PRG-NY-15-002 An unscheduled visit is allowed at any time if in the investigator's opinion it is warranted. If the investigator assesses the subject's condition and determines that the subject's condition has worsened to the degree that it is unsafe for the subject to continue in the stu... | [] |
NCT02459795 | 5.13 | Summary of Assessments | 5.13 Summary of Assessments | [] |
NCT02459795 | 5.14 | Screen Failures | 5.14 Screen Failures A screen failure is a subject who received information about the study, including signing an informed consent/assent, and possibly performing some study related procedures but was not enrolled, dispensed and applied study medication. Screen failures information will not be entered in the database a... | [] |
NCT02459795 | 5.15 | Protocol Deviations/Violations | 5.15 Protocol Deviations/Violations This study will be conducted as described in this protocol except for an emergency situation in which the protection, safety, and well-being of the subject requires immediate intervention, based on the judgment of the investigator or a responsible, appropriately trained and credentia... | [] |
NCT02459795 | 5.16 | Subject/Treatment Compliance | 5.16 Subject/Treatment Compliance Subjects will apply the medication to the designated treatment area at approximately the same time once daily for 2 consecutive days. . Compliance will be determined from the diary card, in which the subject will be instructed to record all applications made or missed. The first and la... | [] |
NCT02459795 | 5.17 | Discontinuation/Withdrawal of Study Subjects | 5.17 Discontinuation/Withdrawal of Study Subjects Subjects will be removed from the study for any of the following reasons: - The subject withdraws his or her consent/assent for any reason. - The subject's condition has worsened to the degree that the investigator feels it is unsafe for the subject to continue in the s... | [] |
NCT02459795 | 6 | MATERIALS AND SUPPLIES | 6. MATERIALS AND SUPPLIES | [] |
NCT02459795 | 6.1 | Study Medication | 6.1 Study Medication The study medication supplied by Perrigo Israel Pharmaceuticals, Ltd. will consist of: | | Test Product: Ingenol MebutateTopical Gel 0.05%, | |------------------------|------------------------------------------------------| | Perrigo New York, Inc. | | Reference Product: Picato® Topical Gel 0.05% (... | [] |
NCT02459795 | 6.2 | Medication Management | 6.2 Medication Management | [] |
NCT02459795 | 6.2.1 | Labeling, Packaging and Distribution | 6.2.1 Labeling, Packaging and Distribution The study medication assigned to each subject number will be determined by a computergenerated randomization schedule. Study medication is labeled and packaged, according to the random code, so that neither the subject nor the investigator can identify the treatment. All study... | [] |
NCT02459795 | 6.2.2 | Retention Samples | 6.2.2 Retention Samples Each investigational site where study medication is dispensed to at least one subject will be required to randomly select retain samples. The retention samples must be stored under labeled conditions [in a refrigerator at 36o -46o F (2-8o C); excursions permitted to 32o -59o F (0o -15o C)] even ... | [] |
NCT02459795 | 6.2.3 | Storage and Test Article Accountability | 6.2.3 Storage and Test Article Accountability Study articles used to conduct this study will be maintained under adequate security by the investigator or designee. Study test articles will be stored in a refrigerator at a temperature of 36o - 46o F (2-8o C); excursions permitted between 32o - 59o F (0o -15o C) in a sec... | [] |
NCT02459795 | 6.2.4 | Randomization | 6.2.4 Randomization Randomization will be performed according to a computer generated randomization scheme where the treatment group designation has been assigned to the subject number. The treatment designation will remain blinded until the final database is closed. An independent third party will hold the randomizati... | [] |
NCT02459795 | 6.2.5 | Procedure for Breaking the Blind | 6.2.5 Procedure for Breaking the Blind The investigator, staff at the study site, study monitors, and data analysis/management personnel are blinded to the subject assignment. In the event of an emergency, the specific subject treatment may be identified by removing the overlay of the blinded label for each subject at ... | [] |
NCT02459795 | 7 | ADVERSE REACTIONS | 7. ADVERSE REACTIONS The potential adverse reactions of generic Ingenol Mebubate Topical Gel 0.05% are anticipated to be similar to those observed in Picato® Topical Gel (Ingenol Mebutate Topical Gel 0.05%). The most common adverse reactions related to treatment with Picato® Topical Gel include local skin reactions, ap... | [] |
NCT02459795 | 7.1 | Departure from the Protocol for Individual Subjects | 7.1 Departure from the Protocol for Individual Subjects When an emergency occurs requiring a departure from the protocol for a subject, departure will be only for that subject. In such circumstances, the investigator or other physician in attendance will contact the Medical Monitor or Perrigo by telephone and follow up... | [] |
NCT02459795 | 7.2 | Definitions | 7.2 Definitions An adverse event (AE) is defined as any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (for example, an abnormal laborat... | [
"Definitely - The AE:",
"Probably - The AE:",
"Possible - The AE:",
"Unlikely - The AE:",
"Not related - The AE:"
] |
NCT02459795 | 7.3 | Eliciting and Reporting of Adverse Events | 7.3 Eliciting and Reporting of Adverse Events The investigator will periodically assess subjects for the occurrence of adverse events. In order to avoid bias in eliciting adverse events, the subject or parent/legally authorized representative should be asked a non-specific question (e.g., "How have you been feeling sin... | [] |
NCT02459795 | 7.3.1 | Expedited Reporting Responsibilities of the Study Center | 7.3.1 Expedited Reporting Responsibilities of the Study Center For any serious or unexpected adverse event, Perrigo must be notified within 24 hours of when the Investigator first learns of the occurrence of the event. Expedited reporting requirements for serious adverse events are described below. Adequate information... | [] |
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