Zoekresultaten - Portaal voor medische datamodellen (MDM-portaal)

Pharmacokinetic Study of Doxorubicin in Children With Cancer DRKS00003787 NCT01095926 - 1st Sampling period

- 27-09-21 - 2 Formulieren, 20 Itemgroepen, 113 Data-elementen, 1 Taal

Itemgroepen: Physical Examination, Determination of cardiac function (before sampling period), Clinical chemistry, Haematology, Agents that are known to interact with doxorubicin according to SmPCs administered?, Antiemetic agents administered?, Cardioprotective agents administered?, Systemic antimycotic agents, Other agents administered?, Actual protocol block, Start of actual protocol block, Chemotherapy in actual protocol block administered ?, Previous anthracycline treatment, Doxorubicin treatment in 1st sampling period, Haematological toxicity of actual protocol block, Transfusions, Determination of cardiac function (end of sampling period), Adverse events, Start of next protocol block, Footer module

Official Title: Phase II Pharmacokinetic Study to Assess the Age-dependency in the Clearance of Doxorubicin in Paediatric Patients With Solid Tumours and Leukaemia Analyze pharmacokinetics of doxorubicin in children with cancer. Furthermore investigate the predictive role of troponin and natriuretic peptides for anthracycline-induced cardiotoxicity. https://clinicaltrials.gov/ct2/show/NCT01095926 NCT01095926

Registration

6 Itemgroepen 25 Data-elementen

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - ECG Abnormalities Form

- 27-09-21 - 1 Formulier, 8 Itemgroepen, 98 Data-elementen, 1 Taal

Itemgroepen: Administrative Data, ECG Abnormalities, Rhythm, P-Wave and QRS Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation (QRS-T), Other Abnormalities

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about any recorded ECG abnormalities during the study. It should be filled out everytime an ECG is performed.

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Dermatological/Hypersensitivity Adverse Event Form

- 20-09-21 - 1 Formulier, 11 Itemgroepen, 66 Data-elementen, 1 Taal

Itemgroepen: Administrative Data, Dermatological/Hypersensitivity Adverse Event, Systemic Symptoms, Signs or Laboratory Abnormalities, Haematologic Abnormalities, Supportive/Investigative Measures, Diagnosis, Responsible for Diagnosis, Lesion Location, Concomitant Medication, Infections, Conclusion

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about any dermatological or hypersensitivity adverse event form. It should be filled out when any of those occur during the study. Record details of any dematological/hypersensitivity adverse event in the appropriate Non-Serious Adverse/Serious Adverse Event section of the CRF. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - PD (Cytokines)

- 12-11-19 - 1 Formulier, 3 Itemgroepen, 7 Data-elementen, 1 Taal

Itemgroepen: Administrative Data, Dosing date/time, Predose pharmacodynamic sample

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form is used to record the time at which pharmacodynamic samples are taken at Visit 2 (at night before bedtime and during the morning before breakfast).

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Investigational Product and Treatment Confirmation

- 11-11-19 - 1 Formulier, 3 Itemgroepen, 8 Data-elementen, 1 Taal

Itemgroepen: Administrative Data, Investigational Product, Treatment Confirmation

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). The purpose of this form is to record the timing of the investigational product and to confirm the correct treatment at Visits 2, 3 and 8. There is a seperate form for the investigational product administered at Visits 4 to 7.

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Neurological Examination Record

- 28-01-19 - 1 Formulier, 4 Itemgroepen, 12 Data-elementen, 1 Taal

Itemgroepen: Administrative Data, Neurological Examination, Neurological Examination Results, Neurological Examination Conclusion

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about any recorded neurological abnormalities during the study. It should be filled out at screening and anytime an additional neurological examination is performed.

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Concomitant Medication

- 25-01-19 - 1 Formulier, 4 Itemgroepen, 18 Data-elementen, 1 Taal

Itemgroepen: Administrative Data, Concomitant Medication, Concomitant Medication Details, Conclusion

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about any concomitant medication the subject used during the study. It should be filled out at screening (, transcribed to the main form) and updated every visit. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - ECG (Screening)

- 23-01-19 - 1 Formulier, 3 Itemgroepen, 9 Data-elementen, 1 Taal

Itemgroepen: Administrative Data, 12-Lead Electrocardiogram, Conclusion

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about the subjects 12-lead electrocardiogram. All ECGs will be recorder after 10 minutes rest in the semi-supine position. It should be filled out at screening visit. Unscheduled ECGs should be recorded whenever they have been performed Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - 12-Lead ECG Form

- 23-01-19 - 1 Formulier, 2 Itemgroepen, 12 Data-elementen, 1 Taal

Itemgroepen: Administrative Data, 12-Lead Electrocardiogram

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form is for documentation of the ECG. It should be filled out at each study visit. 3 measurements will be taken Pre dose on Day 1, the baseline will be considered the mean of the 3 measurements on day 1. 1 measurement will be taken post dose on day 2 and 3. Unscheduled ECGs should be documented in this form whenever they are performed during the study. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Unscheduled 12-Lead ECG Form

- 23-01-19 - 1 Formulier, 2 Itemgroepen, 8 Data-elementen, 1 Taal

Itemgroepen: Administrative Data, Unscheduled 12-Lead Electrocardiogram

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder Unscheduled ECGs should be documented in this form whenever they are performed during the study. If an ECG is deemed Abnormal, clinically significant, complete the “ECG Abnormalities” page in the CRF. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Serious Adverse Event Notification Form

- 18-01-19 - 1 Formulier, 15 Itemgroepen, 62 Data-elementen, 1 Taal

Itemgroepen: Administrative Data, Serious Adverse Event, SECTION 1: Serious Adverse Event Record, SECTION 2: Seriousness, SECTION 3: Demography Data, SECTION 4: Serious Adverse Event Recurrence, SECTION 5: Causes of SAE, SECTION 6: Relevant Medical Conditions, SECTION 7: Other Relevant Risk Factors, SECTION 8: Relevant Concomitant Medications, SECTION 9: Details of Investigational Product(s), SECTION 10: Details of Relevant Assessments, SECTION 11: Narrative Remarks, Conclusion, SECTION 12: Additional/Follow-Up Information

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder The purpose of this form is to document any serious adverse events. A serious adverse event is defined as follows: A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death. b) is life-threatening. Note: The term ‘life-threatening’ in the definition of ‘serious’ refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe. c) requires hospitalisation or prolongation of existing hospitalisation. Note: In general, hospitalisation signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician’s office or out-patient setting. Complications that occur during hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils any other serious criteria, the event is ’serious’. When in doubt as to whether ’hospitalisation’ occurred or was necessary, the AE should be considered ’serious’. Hospitalisation for elective treatment of a preexisting condition that did not worsen from baseline is not considered an AE. d) results in disability/incapacity, or Note: The term disability means a substantial disruption of a person’s ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhoea, influenza, and accidental trauma (e.g., sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption. e) is a congenital anomaly/birth defect. f) other. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or development of drug dependency or drug abuse. SECTION 4: If Investigational Product was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s)Were Administered? If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur? SECTION 9: Details of Investigational Product Complete this section using the information in the Investigational Product page. Details of all investigational product(s) taken until the time of the SAE should be included. Provide specific details in Section 11 Narrative Remarks if the subject has taken an overdose of investigational product(s), including whether it was accidental or intentional. SECTION 12: SAE Additional/Follow-up Information On receipt of follow-up information, the appropriate section(s) on the SAE form must be amended/updated with any changes (i.e., diagnosis, end date or death, change in intensity, or causality). These changes must be initialled and dated with confirmation by the investigator with his/her re-signing the form and forwarded to GSK within 24 hours. The investigator and others responsible for subject care should institute any supplementary investigations of SAEs based on their clinical judgement of the likely causative factors. This may include seeking a further opinion from a specialist in the field of the AE. GSK may also request extra tests or extra follow-up information. If a subject dies, any post-mortem/autopsy findings, including histopathology, must be provided to GSK.

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Pregnancy Notification Form

- 18-01-19 - 1 Formulier, 6 Itemgroepen, 45 Data-elementen, 1 Taal

Itemgroepen: Administrative Data, Mother's relevant medical/family history, Father's Relevant Medical/Family History, Drug Exposures, Study Withdrawal, Reporting Investigator Information

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form should be completed according to the protocol reporting requirements. Complete this form for each subject who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail or fax (fax preferred) within two weeks of learning of the pregnancy. Original pages should remain with the subject’s Case Report Form. Note: This form does not routinely need to be completed for subject’s partner pregnancy unless there is specific instruction to do so stated in the protocol.

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