protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03582215 | 5.6.3.2 | Treatment | 5.6.3.2 Treatment The following procedures and assessments will be performed during the treatment period (Days 1 through 4) according to the Schedule of Events (Section 10.1): - Measure vital signs (blood pressure, heart rate, respiratory rate, and oral body temperature) before dosing - Collect PK blood sample (10 mL) ... | [] |
NCT03582215 | 5.6.3.3 | Washout | 5.6.3.3 Washout Not applicable. | [] |
NCT03582215 | 5.6.4 | Discharge (or Early Termination) | 5.6.4 Discharge (or Early Termination) The following procedures and assessments will be performed before the subject is discharged from the study or upon early termination: - Measure vital signs (blood pressure, heart rate, respiratory rate, and oral body temperature) - Physical examination of skin at the sites of topi... | [] |
NCT03582215 | 5.6.5 | Follow-up | 5.6.5 Follow-up The following procedures and assessments will be performed on Days 10, 14 and 21 for Part 2: - Measure vital signs (blood pressure, heart rate, respiratory rate, and oral body temperature) - Collect PK blood samples (10 mL) after dosing as follows: - o Day 10: 216 hours after first dose on Day 1 (Part 2... | [] |
NCT03582215 | 5.7 | Study Procedures | 5.7. Study Procedures | [] |
NCT03582215 | 5.7.1 | Pharmacokinetic Assessments | 5.7.1 Pharmacokinetic Assessments | [] |
NCT03582215 | 5.7.1.1 | Pharmacokinetic Sample Collection | 5.7.1.1 Pharmacokinetic Sample Collection Pharmacokinetic blood samples (approximately 10 mL per sample) will be collected for determination of avobenzone, oxybenzone, octocrylene, ecamsule, homosalate, octisalate and octinoxate plasma concentrations (where applicable to the different sunscreen formulations) at the fol... | [] |
NCT03582215 | 5.7.1.2 | Tape Stripping Sample Collection | 5.7.1.2 Tape Stripping Sample Collection For Part 2 only, tape stripping of the lower back to an area of around 3.8 cm2 will be conducted once on Days 7 and 14 to determine residual sunscreen active ingredients in the superficial layers of the skin. Tape stripping will be applied to different areas of the lower back on... | [] |
NCT03582215 | 5.7.1.3 | Pharmacokinetic Specimen Handling | 5.7.1.3 Pharmacokinetic Specimen Handling The PK blood samples (10 mL each) will be collected into tubes containing K2EDTA, inverted several times to mix the blood with the anticoagulant, and placed in an ice bath. Within 30 minutes of collection, the samples will be centrifuged for 10 minutes, at 3000 revolutions per ... | [] |
NCT03582215 | 5.7.1.4 | Pharmacokinetic Parameters | 5.7.1.4 Pharmacokinetic Parameters The following PK parameters will be determined for each subject for each active ingredient: Across all study days (Primary Endpoint) Maximum concentration (observed peak drug concentration) (Cmax)
Days 1 - Maximum concentration (observed peak drug concentration) (Cmax) - Time at whic... | [
"Days 1",
"Days 2 and 3",
"Day 4",
"Days 5, 6, 7, 10 (Part 2 only), 14 (Part 2 only) and 21 (Part 2 only)"
] |
NCT03582215 | 5.7.2 | Safety Assessments | 5.7.2 Safety Assessments Safety will be evaluated in terms of AEs, vital sign measurements (blood pressure, heart rate, respiratory rate, and oral body temperature), and physical examination findings. | [] |
NCT03582215 | 5.7.2.1 | Adverse Events | 5.7.2.1 Adverse Events | [] |
NCT03582215 | 5.7.2.1.1 | Adverse Event Definitions | 5.7.2.1.1 Adverse Event Definitions An AE is defined as any untoward and/or unintended sign, including an abnormal clinical laboratory finding, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. Events or conditions that increase in frequency or ... | [] |
NCT03582215 | 5.7.2.1.2 | Adverse Event Reporting | 5.7.2.1.2 Adverse Event Reporting The recording of AEs will begin after the subject signs the informed consent form and will continue until discharge (or early termination). All AEs, whether serious or nonserious and whether or not related to the study drug, must be recorded in the eCRF. Study subjects will be instruct... | [] |
NCT03582215 | 5.7.2.1.3 | Assessment of Severity | 5.7.2.1.3 Assessment of Severity The investigator will assess the severity of each AE using the following scale: - Mild: The subject is aware of the AE but is still able to perform all activities; minimal or no medical intervention or therapy is required. - Moderate: The subject has to discontinue some activities due t... | [] |
NCT03582215 | 5.7.2.1.4 | Assessment of Causality | 5.7.2.1.4 Assessment of Causality The investigator will assess the causal relationship/relatedness of each AE to the study drug using the following scale: - Not Related: Onset of the AE has no reasonable temporal relationship to administration of the study drug, a causal relationship to administration of the study drug... | [] |
NCT03582215 | 5.7.2.1.5 | Pregnancy | 5.7.2.1.5 Pregnancy A serum pregnancy test will be performed for female subjects at the time points presented in the Schedule of Events (Section 10.1). If a subject becomes pregnant while on the study, this should be reported immediately to the investigator, the subject will be withdrawn from the study and the medical ... | [] |
NCT03582215 | 5.7.2.2 | Clinical Laboratory Tests | 5.7.2.2 Clinical Laboratory Tests Clinical laboratory and diagnostic screening tests will be performed at the time points presented in the Schedule of Events (Section 10.1) and will be collected in accordance with acceptable laboratory procedures. Clinical laboratory testing will be performed by Spaulding Clinical Labo... | [] |
NCT03582215 | 5.7.2.3 | Vital Sign Measurements | 5.7.2.3 Vital Sign Measurements Vital signs (blood pressure, heart rate, respiratory rate, and oral body temperature) will be measured using an automated device at the time points presented in the Schedule of Events (Section 10.1). The subject should be in a supine position, if possible, for a minimum of 5 minutes befo... | [] |
NCT03582215 | 5.7.2.4 | Safety 12-Lead Electrocardiograms | 5.7.2.4 Safety 12-Lead Electrocardiograms Safety 12-lead ECGs will be performed at the time points presented in the Schedule of Events (Section 10.1). The subject should be in a supine position, if possible, for approximately 10 minutes before safety 12-lead ECGs are measured. The safety 12-lead ECGs will be reviewed b... | [] |
NCT03582215 | 5.7.2.5 | Physical Examinations | 5.7.2.5 Physical Examinations Physical examinations will be performed at the time points presented in the Schedule of Events (Section 10.1). The complete physical examination at Screening will include, but not be limited to, assessments of the head, eyes, ears, nose, throat, skin, thyroid, nervous system, respiratory s... | [] |
NCT03582215 | 5.7.3 | Demographics and Medical History | 5.7.3 Demographics and Medical History Demographic data (date of birth, gender, race, and ethnicity) will be collected at Screening. Each subject will provide a complete medical history at Screening that will be reviewed at Check-in. Specific information relating to any prior or existing medical conditions/surgical pro... | [] |
NCT03582215 | 5.8 | Study Treatments | 5.8. Study Treatments | [] |
NCT03582215 | 5.8.1 | Treatments Administered | 5.8.1 Treatments Administered
Part 1 - La Roche Posay (Cream), Anthelios SX Daily Moisturizer Cream, Face Sunscreen SPF 15 with Mexoryl SX - Hawaiian Tropic (Lotion); Island Sport Ultra-Light High Performance Sunscreen, SPF 50 - Neutrogena (Spray), Ultra Sheer Body Mist SPF 45 - Banana Boat (Spray); Sport Performance ... | [
"Part 1",
"Part 2"
] |
NCT03582215 | 5.8.2 | Method Assigning Subjects to Treatment | 5.8.2 Method Assigning Subjects to Treatment | [] |
NCT03582215 | 5.8.2.1 | Randomization Process | 5.8.2.1 Randomization Process
Part 1 and Part 2 The FDA project biostatistician will create the specifications that will be used to generate the randomization schedule. The specifications will be based on the protocol requirements and appropriate statistical programming with consideration for study design, number of t... | [
"Part 1 and Part 2"
] |
NCT03582215 | 5.8.3 | Identity of Study Drug | 5.8.3 Identity of Study Drug The topical sunscreen formulations described in Section 5.8.1 are commercially available OTC products containing the active components avobenzone, oxybenzone, octocrylene, ecamsule, homosalate, octisalate and octinoxate, where applicable. | [] |
NCT03582215 | 5.8.4 | Management of Clinical Supplies | 5.8.4 Management of Clinical Supplies | [] |
NCT03582215 | 5.8.4.1 | Study Drug Packaging and Storage | 5.8.4.1 Study Drug Packaging and Storage The topical sunscreen formulations will be obtained from commercial sources and stored according to the manufacturer's directions. | [] |
NCT03582215 | 5.8.4.2 | Study Drug Accountability | 5.8.4.2 Study Drug Accountability Good clinical documentation practices will be employed to record the receipt, storage conditions, accountability, and use or return of the study drug. The study drug will be stored in a secure location with access to the study personnel who will be managing the storage, dispensing, and... | [] |
NCT03582215 | 5.8.5 | Blinding | 5.8.5 Blinding Both parts of this study are open-label; therefore, blinding is not applicable. | [] |
NCT03582215 | 5.8.6 | Treatment Compliance | 5.8.6 Treatment Compliance At Screening, as part of the eligibility assessment, it will be confirmed that subjects can comply with the protocol-defined procedure of topical study drug application. All applications of the study drug will be administered in the study clinic either under direct observation of or administe... | [] |
NCT03582215 | 5.8.7 | Prior and Concomitant Medications | 5.8.7 Prior and Concomitant Medications Subjects are prohibited from having received or applied the topical sunscreen formulations used in the current study within 7 days before Check-in (Day 0). Subjects are also prohibited from having used any personal care product(s) containing any active sunscreen ingredient, such ... | [] |
NCT03582215 | 5.8.8 | Subject Restrictions | 5.8.8 Subject Restrictions At Screening, as part of the eligibility assessment, it will be confirmed that subjects have not used a tanning bed in the previous 4 weeks before the study. As part of the medical history assessment at Screening, subjects will be asked about their smoking history. Subject responses will be r... | [] |
NCT03582215 | 5.9 | Statistical Methods | 5.9. Statistical Methods | [] |
NCT03582215 | 5.9.1 | Sample Size | 5.9.1 Sample Size Approximately 72 healthy subjects are planned for enrollment, of which 24 subjects will be enrolled and randomized in Part 1 and 48 subjects will be enrolled and randomized in Part 2. The sample size was determined empirically and is typical for exploratory investigations of this type. | [] |
NCT03582215 | 5.9.2 | Analysis Populations | 5.9.2 Analysis Populations The PK population will include all subjects who receive study drug and have at least 1 estimable PK parameter after dosing. The safety population will include all subjects who receive at least 1 dose of any of the study drugs. | [] |
NCT03582215 | 5.9.3 | General Statistical Considerations | 5.9.3 General Statistical Considerations All data will be presented in data listings. Data from subjects excluded from an analysis population will be presented in the data listings but not included in the calculation of summary statistics. | [] |
NCT03582215 | 5.9.4 | Subject Disposition | 5.9.4 Subject Disposition The number of subjects who enroll in the study and the number and percentage of subjects who complete each assessment will be presented. The frequency and percentage of subjects who withdraw or discontinue from the study and the reason for withdrawal or discontinuation will be summarized. | [] |
NCT03582215 | 5.9.5 | Demographic and Baseline Characteristics | 5.9.5 Demographic and Baseline Characteristics Demographic and baseline characteristics will be summarized overall and by treatment for all subjects. | [] |
NCT03582215 | 5.9.6 | Pharmacokinetic Analyses | 5.9.6 Pharmacokinetic Analyses Plasma concentrations and PK parameters of avobenzone, oxybenzone, octocrylene, ecamsule, homosalate, octisalate and octinoxate (where applicable) will be listed and summarized using descriptive statistics (n, arithmetic mean, SD, minimum, median, and maximum) by nominal PK sampling time. | [] |
NCT03582215 | 5.9.7 | Safety Analyses | 5.9.7 Safety Analyses | [] |
NCT03582215 | 5.9.7.1 | Adverse Events | 5.9.7.1 Adverse Events Any AEs will be coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA). The incidence of AEs, organized by system organ class and frequency, will be summarized by seriousness, severity, relationship to treatment, and by treatment, with a focus on TEAEs. A deta... | [] |
NCT03582215 | 5.9.7.2 | Clinical Laboratory Tests | 5.9.7.2 Clinical Laboratory Tests Clinical laboratory results (hematology, serum chemistry, and urinalysis) will be summarized using descriptive statistics (number of subjects, mean, SD, minimum, median, and maximum). Clinical laboratory results will be classified as normal or abnormal, according to the reference range... | [] |
NCT03582215 | 5.9.7.3 | Vital Sign Measurements | 5.9.7.3 Vital Sign Measurements Vital sign measurements and changes from Baseline will be summarized using descriptive statistics (number of subjects, mean, SD, minimum, median, and maximum) by treatment and time point. | [] |
NCT03582215 | 5.9.7.4 | Safety 12-Lead Electrocardiograms | 5.9.7.4 Safety 12-Lead Electrocardiograms Safety 12-lead ECG data will be summarized using descriptive statistics (number of subjects, mean, SD, minimum, median, and maximum). | [] |
NCT03582215 | 5.9.7.5 | Physical Examinations | 5.9.7.5 Physical Examinations Physical examination findings will be presented in a data listing, and abnormal physical examination findings will be recorded as AEs. | [] |
NCT03582215 | 5.9.7.6 | Other Safety Data | 5.9.7.6 Other Safety Data All concomitant medication usage and medications that changed in daily dose, frequency, or both since the subject provided informed consent will be summarized for each subject. | [] |
NCT03582215 | 5.9.8 | Interim Analyses | 5.9.8 Interim Analyses No interim analyses are planned. | [] |
NCT03582215 | 5.9.9 | Missing Data | 5.9.9 Missing Data Missing data will not be imputed. Data that are excluded from the descriptive or inferential analyses will be included in the subject data listings. This will include data from subjects not in the particular analysis population, measurements from unscheduled visits, or extra measurements that may ari... | [] |
NCT03582215 | 5.10 | Data Quality Assurance | 5.10. Data Quality Assurance Completed eCRFs are required for each subject randomly assigned to study drug. Electronic data entry will be accomplished through the ClinSpark® remote electronic data capture system, which allows for on-site data entry and data management. This system provides immediate, direct data transf... | [] |
NCT03582215 | 6 | Ethical Considerations | 6. Ethical Considerations | [] |
NCT03582215 | 6.1 | Ethical Conduct of the Study | 6.1. Ethical Conduct of the Study This study will be performed in accordance with the recommendations guiding physicians in biomedical research involving human subjects adopted by the 18th World Medical Association General Assembly, Helsinki, Finland, 1964 and later revisions, as well as, United States Title 45 Code of... | [] |
NCT03582215 | 7 | Institutional Review Board (IRB) | 7. Institutional Review Board (IRB) The investigator will provide the local IRB with all required documents, including the study protocol and informed consent form and recruitment materials. The study will not be initiated until appropriate IRB approval is obtained. The subjects will be informed that they have the righ... | [] |
NCT03582215 | 8 | Administrative Procedures | 8. Administrative Procedures | [] |
NCT03582215 | 8.1 | Responsibilities of the Investigator | 8.1. Responsibilities of the Investigator The following administrative items are meant to guide the investigator in the conduct of the study but may be subject to change based on industry and government standard operating procedures, working practice documents, or guidelines. Changes may be reported to the IRB but will... | [] |
NCT03582215 | 8.1.1 | Form FDA 1572 | 8.1.1 Form FDA 1572 The investigator will complete and sign the Form FDA 1572. | [] |
NCT03582215 | 8.1.2 | Adherence to Protocol | 8.1.2 Adherence to Protocol The investigator agrees to conduct the study as outlined in this protocol in accordance with the ICH E6(R1) and all applicable guidelines and regulations. | [] |
NCT03582215 | 8.1.3 | Reporting Requirements | 8.1.3 Reporting Requirements By participating in this study, the investigator agrees to submit reports of SAEs according to the time line and method outlined in the protocol (Section 5.7.2.1.2). In addition, the investigator agrees to submit reports to the IRB as appropriate. The investigator also agrees to provide the... | [] |
NCT03582215 | 8.1.4 | Source Documentation | 8.1.4 Source Documentation By participating in this study, the investigator agrees to maintain adequate case histories for the subjects treated as part of the research under this protocol. The investigator agrees to maintain accurate eCRFs and source documentation as part of the case histories. | [] |
NCT03582215 | 8.1.5 | Retention of Records | 8.1.5 Retention of Records The investigator agrees to keep the records stipulated in this protocol and those documents that include (but are not limited to) the study-specific documents, identification log of all participating subjects, medical records, source worksheets, all original signed and dated informed consent ... | [] |
NCT03582215 | 8.1.6 | Financial Disclosure and Obligations | 8.1.6 Financial Disclosure and Obligations The investigator is required to provide financial disclosure information to allow the sponsor to submit the complete and accurate certification or disclosure statements required under 45 CFR 45. In addition, the investigator must provide to the sponsor a commitment to update t... | [] |
NCT03582215 | 8.2 | Confidentiality and Disclosure of Data | 8.2. Confidentiality and Disclosure of Data All subjects will sign a HIPAA-compliant authorization form containing the mandated core elements and requirements before participation in this clinical study. The sponsor and designees affirm and uphold the principle of the subject's right to protection against invasion of p... | [] |
NCT03582215 | 8.3 | Certificate of Confidentiality | 8.3. Certificate of Confidentiality In order to protect the privacy of subjects, Certificates of Confidentiality will be obtained prior to the initiation of the study. | [] |
NCT03582215 | 8.4 | Subject Consent | 8.4. Subject Consent Written informed consent in compliance with 45 CFR 46 will be obtained from each subject before entering the study or performing any unusual or nonroutine procedure that involves risk to the subject. An informed consent template may be provided by the sponsor to the study clinic. If any institution... | [] |
NCT03582215 | 8.5 | Data Collection | 8.5. Data Collection Full details of procedures for data collection and handling will be documented in the data management plan, which is initiated with the final protocol receipt. The data management plan is a changing document that evolves over the course of the study and is finalized by database lock. | [] |
NCT03582215 | 8.6 | Publications | 8.6. Publications No information related to or generated by this study will be released to the public until it has been reviewed by the sponsor. The sponsor shall own intellectual rights for the data and analysis resulting from this study and results cannot be presented or published without written permission from the ... | [] |
NCT03582215 | 9 | Study Management | 9. Study Management | [] |
NCT03582215 | 9.1 | Release of Study Drug to the Study Clinic | 9.1. Release of Study Drug to the Study Clinic Before the study drug can be released to the study clinic, the following documents will be collected from the study clinic by the clinical research organization, retained in the trial master file, and a study drug shipment approval form will be completed by the clinical re... | [] |
NCT03582215 | 9.2 | Monitoring | 9.2. Monitoring | [] |
NCT03582215 | 9.2.1 | Monitoring of the Study | 9.2.1 Monitoring of the Study The sponsor or its designee will monitor the study to ensure that it is being conducted according to the protocol, GCP standards, and applicable region-specific requirements, and to ensure that study initiation, conduct, and closure are adequate. The investigators and the study clinic staf... | [] |
NCT03582215 | 9.3 | Management of Protocol Amendments and Deviations | 9.3. Management of Protocol Amendments and Deviations | [] |
NCT03582215 | 9.3.1 | Modification of the Protocol | 9.3.1 Modification of the Protocol Any changes in this research activity, except those necessary to remove an apparent immediate hazard to the subject, must be submitted to the sponsor or designee and reviewed and approved by the IRB before implementation. Amendments to the protocol must be submitted in writing to the ... | [] |
NCT03582215 | 9.3.2 | Protocol Violations and Deviations | 9.3.2 Protocol Violations and Deviations Any significant protocol deviations that the investigator or study clinic staff believes are of major importance (e.g., incorrect randomizations, subject enrolled but not eligible) should be reported to the IRB as soon as possible. Significant protocol deviations may include the... | [] |
NCT03582215 | 11 | Reference List | 11. Reference List - 1) Department of Health and Human Services, Food and Drug Administration (US), Center for Drug Evaluation and Research (CDER). Guidance for Industry: Nonprescription Sunscreen Drug Products – Safety and Effectiveness Data. November 2016. - 2) Variation in stratum corneum protein content as a functi... | [] |
NCT03595618 | 1 | ADMINISTRATIVE STRUCTURE OF THE STUDY | 1. ADMINISTRATIVE STRUCTURE OF THE STUDY Galapagos will act as sponsor of the Study in the United States of America (including its territories and possessions) (the "US Territory") and Servier will act as sponsor of the Study in all countries except the US Territory (the "ROW Territories"). Each of Galapagos and Servie... | [] |
NCT03595618 | 2 | BACKGROUND INFORMATION | 2. BACKGROUND INFORMATION S201086 is also developed by Galapagos N.V. under the code GLPG1972.
Definition and epidemiology of osteoarthritis Osteoarthritis (OA) is a degenerative joint disease involving the structure of all joint tissues including articular cartilage, subchondral bone, ligaments, capsule, and synovial... | [
"Definition and epidemiology of osteoarthritis",
"Standard of care treatment",
"Aggrecanase in OA",
"Overview of \\$S201086/GLPG1972",
"Clinical studies",
"Safety data",
"Pharmacokinetics",
"Clinical pharmacodynamics",
"Rationale for study design",
"Study Design",
"Study population",
"Study pr... |
NCT03595618 | 3 | STUDY OBJECTIVES AND PURPOSE | 3. STUDY OBJECTIVES AND PURPOSE
Objectives: The objectives of this study are to evaluate the efficacy and safety of 3 doses of \$201086/GLPG1972 compared to placebo in patients with knee OA. The primary objective of the study is to demonstrate the efficacy of at least one dose (among 3 doses) of S201086/GLPG1972 compa... | [
"Objectives:",
"The secondary objectives are:",
"Exploratory objectives are:"
] |
NCT03595618 | 4 | STUDY DESIGN | 4. STUDY DESIGN This study is a phase 2, international, multi-regional, multicenter, randomized, double-blind, parallel-group, placebo-controlled, dose-ranging study of 52 weeks. | [] |
NCT03595618 | 4.1 | Endpoints | 4.1. Endpoints
The primary efficacy endpoint: The change from baseline to W052 in cartilage thickness of the cMTFC of the target knee: qMRI.
Secondary efficacy endpoints: - Proportion of structural progressors\ at W052 based on cartilage thickness of the cMTFC of the target knee: qMRI - The change from baseline to W0... | [
"The primary efficacy endpoint:",
"Secondary efficacy endpoints:",
"Other secondary endpoints:",
"Safety",
"Pharmacokinetics:",
"Exploratory endpoints:"
] |
NCT03595618 | 4.2 | Experimental design | 4.2. Experimental design | [] |
NCT03595618 | 4.2.1 | Study plan | 4.2.1. Study plan The expected duration of patient participation will be 61 weeks maximum. The study is divided into the following periods: - An up to 5-week screening period without study treatment from screening visit (ASSE) to inclusion visit (W000). The screening period (up to 5 weeks) will allow enough time to obt... | [] |
NCT03595618 | 4.2.2 | Investigation schedule | 4.2.2. Investigation schedule Table (4.2.2) 1 describes the measurement of efficacy and safety assessed during the study. Table (4.2.2) 1 - Investigation schedule | | ScreeningASSE(up to5w) | InclusionW000 | W004(+/-5d) | W008(+/-5d) | W012(+/-5d) | W020(+/-7d) | W028(+/-7d) | W040(+/-7d)(end ofmorning orafternoonvisit... | [] |
NCT03595618 | 4.3 | Measures to minimize bias | 4.3. Measures to minimize bias - This is a double-blind, placebo-controlled study. - The appearance and taste of the tablets will be the same for all study drugs, in order to protect the blinding with regard to the patients and the investigators. - The treatment, S201086/GLPG1972 75 mg/day, 150 mg/day, 300 mg/day or ma... | [] |
NCT03595618 | 4.4 | Data and safety monitoring board | 4.4. Data and safety monitoring board A Data and Safety Monitoring Board (DSMB) will be put in place in order to independently review the available safety data at regular pre-specified time points. The functioning of this DSMB is specified in a separate DSMB charter. | [] |
NCT03595618 | 5 | INCLUSION OF PATIENTS | 5. INCLUSION OF PATIENTS | [] |
NCT03595618 | 5.1 | Inclusion criteria | 5.1. Inclusion criteria All patients included should present the following characteristics: - 1a. Male patients or female patients of non-childbearing potential and not breastfeeding. Note: Female patients will be considered of non-childbearing potential if they are either surgically sterile (e.g. tubal ligation, hyste... | [] |
NCT03595618 | 5.2 | Exclusion criteria | 5.2. Exclusion criteria 11. Unlikely to cooperate in the study. - 12. Participation in another interventional study within 3 months before screening; participation in non-interventional registries or epidemiological studies is allowed. - 13. Re-screened patient. - 14. Patient unable to understand the study. - 15. Poor ... | [] |
NCT03595618 | 5.3 | Contraception | 5.3. Contraception Within the frame of this study, as the effect of S201086/GLPG1972 on sperm in man is unknown, male clinical study patients and their female partners of child-bearing potential must use highly effective contraception (as described in the informed consent form) in combination with a barrier contracepti... | [] |
NCT03595618 | 5.4 | Discontinuation of the study | 5.4. Discontinuation of the study | [] |
NCT03595618 | 5.4.1 | Premature discontinuation of the study or temporary halt | 5.4.1.Premature discontinuation of the study or temporary halt This study may be temporarily halted or prematurely discontinued at any time for any sufficient reasonable cause. After having informed the national coordinators, the sponsor or the institutional review board (IRB)/independent ethics committee (IEC) or the ... | [] |
NCT03595618 | 5.4.2 | Discontinuation of the study in the event of objective reached | 5.4.2.Discontinuation of the study in the event of objective reached Not applicable | [] |
NCT03595618 | 5.5 | Patient withdrawal | 5.5. Patient withdrawal | [] |
NCT03595618 | 5.5.1 | Withdrawal criteria | 5.5.1.Withdrawal criteria A patient may be discontinued from the clinical study at any time without the patient's consent if the investigator or sponsor determines that it is not in the best interest of the patient to continue participation. In such case, the reason for withdrawal will be documented in the source docum... | [] |
NCT03595618 | 5.5.2 | Procedure | 5.5.2. Procedure - In the case of premature withdrawal from the study due to an AE, the investigator must make every effort to collect the information relating to the outcome of the event. If necessary, the information will be collected afterwards (see Section 8.9). This information is recorded in that part of the eCRF... | [] |
NCT03595618 | 5.5.3 | Lost to follow-up | 5.5.3. Lost to follow-up When the investigator has no news of the patient, he/she must make every effort to contact him/her or a person around him/her (phone calls, letters including registered ones, etc....), to establish the reason for the discontinuation of IMP and to suggest the patient comes to an endof-study visi... | [] |
NCT03595618 | 6 | TREATMENT OF PATIENTS | 6. TREATMENT OF PATIENTS | [] |
NCT03595618 | 6.1 | Study products and blinding systems | 6.1. Study products and blinding systems | [] |
NCT03595618 | 6.1.1 | Products administered | 6.1.1. Products administered IMPs (also mentioned as study drug in this protocol) in this study are the study drug S201086/GLPG1972 (at dose of 75 mg, 150 mg or 300 mg) and matching placebo. The study drug S201086/GLPG1972 will be provided as film-coated tablets for oral use, containing 75 mg S201086-1/G504572 each (S2... | [
"Table (6.1.1) 2 – Description of packaging"
] |
NCT03595618 | 6.1.2 | IMP management | 6.1.2. IMP management Treatment units will be supplied from the « Unité d'Appui Clinique », Les Laboratoires Servier Industrie, 905 route de Saran, 45520 Gidy, France. IMP receipt, dispensing according to the experimental design of the study (for the description of dispensing methods, refer to section 6.3), accountabil... | [] |
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