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dbGaP phs000304 Genes and Blood Clotting Study (GABC) - pht004468.v1.p1

- 12/10/22 - 6 moduli, 1 ItemGroup, 7 elementi, 1 linguaggio

ItemGroup: pht004468

Principal Investigator: David Ginsburg, MD, University of Michigan, Ann Arbor, MI, USA MeSH: von Willebrand Disease,Epistaxis,Stomatitis, Aphthous,Menarche,Menorrhagia,Acne Vulgaris,Eye Color,Hair Color,Sunburn,Skin Pigmentation,Freckles,Dental Caries,Migraine Disorders,Rhinitis, Allergic, Seasonal,Eye Diseases,Refractive Errors,Flatfoot,Functional Laterality,Venous Thromboembolism https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000304 *Objectives:* Use genome-wide approaches to identify genetic variants that influence common thrombosis and hemostasis factors, as well as selected common human traits. *Design/Methods:* The GABC study was a prospective sibling cohort design. Siblings were recruited by targeted email to the undergraduate and graduate student email lists at the University of Michigan. Healthy persons between 14 and 35 years old who had healthy siblings within the same age restriction were able to participate. Study participants agreed to an online informed consent and subsequently completed a 52-question online survey describing their specific bleeding traits as well as many common human traits. Fifty milliliters of blood was collected into a citrate-dextrose solution (ACD) from each participant. An aliquot of whole blood was used for an automated complete blood count analysis and the remainder was processed into platelet poor plasma and buffy coat portions. Plasma and buffy coat aliquots were snap frozen and stored in liquid nitrogen for future studies. 1189 individuals representing 507 sibships were collected between 06/26/2006 and 01/30/2009. *Phenotyping Survey Details:* To characterize individual bruising and bleeding history, the online survey recorded answers to questions based on a modified von Willebrand Disease (VWD) screening questionnaire. To characterize a collection of participant's common human traits, the survey recorded answers to questions about height, weight, presence of skin tags, history of acne, eye color, hair color, hair line characteristics, skin sunburn sensitivity, skin tanning ability, natural skin color, freckling, cheek dimpling, earlobe shape, shoe size, foot arch characteristics, hand fifth digit morphology, history of dyslexia, history of migraine headaches, history of seasonal allergies, history of apthous ulcers, tendency to sneeze while walking into a bright sunny place, history of dental caries, need for corrective eye lenses, handedness and like or dislike of strongly flavored foods. *Biochemical phenotyping:* Assays for plasma Von Willebrand Factor (VWF) antigen were performed using ELISA and "Alphalisa" techniques. Automated complete blood count analysis was performed on a Bayer Advia 120 on all participants (including WBC differential, RBC indices, and platelet count.) For the dbGaP v2 update, new biochemical phenotypes have been submitted and include von Willebrand Factor, von Willebrand Factor propeptide, plasminogen, gamma prime fibrinogen, ADAMTS 13, antithrombin III, protein C, and protein S. All new phenotypes were obtained using "Alphalisa" techniques. *Genotyping Details:* SNP genotyping was performed using genomic DNA extracted from peripheral blood at the Broad Institute, (MIT/Harvard). Genotyping was performed on the Illumina Omni-1 quad chip at the Broad Institute. For the dbGaP v2 update, genotyping data from the Illumina Human Exome was deposited. This study is part of the Gene Environment Association Studies initiative (GENEVA, http://www.genevastudy.org) funded by the trans-NIH Genes, Environment, and Health Initiative (GEI). The overarching goal is to identify novel genetic factors that contribute to blood clotting through large-scale genome-wide association studies of siblings. Genotyping was performed at the Broad Institute of MIT and Harvard, a GENEVA genotyping center. Data cleaning and harmonization was performed by the primary investigators at the University of Michigan, Ann Arbor, and at the GEI-funded GENEVA Coordinating Center at the University of Washington. This study serves as a resource for investigators who are interested in the genetic determinants of specific plasma proteins in a healthy population. The sibling cohort design allows for linkage analysis in addition to association studies. Analysis of thrombosis and hemostasis related traits should help elucidate specific biochemical and genetic networks that maintain hemostasis. We hope to identify specific genetic determinants of VWF levels in order to better understand the factors that influence the development of VWD.

Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636 - End of Study

- 24/10/19 - 1 modulo, 7 itemgroups, 20 elementi, 1 linguaggio

Itemgroups: Administrative documentation, Date of visit, Assessment Date, Pharmacogenetic Test, Informed Consent, Withdraw, Blinded Clinical Study, Status, Medical Devices, Question, Pregnancy, Information, Clinical Trials, Conclusion

Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Study Conclusion

- 01/02/19 - 1 modulo, 4 itemgroups, 10 elementi, 1 linguaggio

Itemgroups: Administrative Data, Study Conclusion, Investigator Comment Log, Signature

Study ID: 101998 Clinical Study ID: 101998 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor GlaxoSmithKline Collaborators N/A Phase Phase 3 Study Recruitment Status Completed Generic Name sumatriptan Trade Name Imitrex ,Imiject ,Imigran Study Indication Migraine Disorders This form contains the conclusion of the study, it should be filled out at the final visit.

TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024 - End of Study

- 19/06/18 - 1 modulo, 6 itemgroups, 21 elementi, 1 linguaggio

Itemgroups: Date of Visit/Assessment, Status of Treatment Blind, Pregnancy, Withdrawal of Consent for PGx (DNA)/Sample Destruction, Study conclusion, Investigators signature

Study ID: 107979 Clinical Study ID: TXA107979 Study Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00843024 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan/naproxen Trade Name: Treximet Study Indication: Migraine Disorders CRF Seiten: 879-993

Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146 - End of Study Record

- 03/07/19 - 1 modulo, 2 itemgroups, 6 elementi, 1 linguaggio

Itemgroups: Administrative documentation, Clinical Trials, End

Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Study Participation Status

- 26/01/19 - 1 modulo, 6 itemgroups, 11 elementi, 1 linguaggio

Itemgroups: Administrative Data, Randomisation Number, Investigational Product Container Number, Previous Clinical Trial Participation (Migraine Treatment), PRIOR PARTICIPATION IN SUMATRIPTAN 85MG / NAPROXEN SODIUM 500MG TABLET STUDIES, Previous Administrative Data

Study ID: 101998 Clinical Study ID: 101998 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor GlaxoSmithKline Collaborators N/A Phase Phase 3 Study Recruitment Status Completed Generic Name sumatriptan Trade Name Imitrex ,Imiject ,Imigran Study Indication Migraine Disorders The purpose of this form is to document the subjects study participation status. It should be filled out at the screening visit.

Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146 - Follow-Up

- 23/06/19 - 1 modulo, 7 itemgroups, 36 elementi, 1 linguaggio

Itemgroups: Administrative documentation, Pregnancy Tests, Vital Signs, Electrocardiography, Laboratory Procedures, Abnormality, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Abnormality, Laboratory Procedures, Urinalysis, Abnormality

Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784 - Study Conclusion and Pregnancy Information

- 25/11/18 - 1 modulo, 3 itemgroups, 8 elementi, 1 linguaggio

Itemgroups: Administrative Data, Study Conclusion, Pregnancy Information

This form contains a form to document the study conclusion and pregnancy information. To be assessed at the follow-up visit. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Investigatioinal Product Use and Status of Treatment Blind

- 02/11/18 - 1 modulo, 3 itemgroups, 7 elementi, 1 linguaggio

Itemgroups: Administrative Data, Investigational Product Use, Status of Treatment Blind

This ODM-file contains the form to document the investigational product use and the status of treatment blind. To be assessed at the final visit. Study ID: 101999 Clinical Study ID: 101999 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Headache Classification

- 20/09/21 - 1 modulo, 4 itemgroups, 12 elementi, 1 linguaggio

Itemgroups: Administrative Information, IHS Headache Classification, Migraine History, Subject Recruitment

https://www.gsk-clinicalstudyregister.com/study/101998#rs Study ID:101998 Clinical Study ID :101998 Study Title :A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data :Study Listed on ClinicalStudyDataRequest.com Sponsor :GlaxoSmithKline Sponsor Identification Number :TRX101998 Collaborators :N/A Phase :Phase 3 Study Recruitment Status :Completed Generic Name :sumatriptan Trade Name :Imitrex ,Imiject ,Imigran Study Indication :Migraine Disorders This form uses the IHS headache classification to evluate the subjects symptoms of headache and migraine and should be filled out at the screening visit.

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Eligibility Criteria

- 20/09/21 - 1 modulo, 4 itemgroups, 41 elementi, 1 linguaggio

Itemgroups: Administrative Information, Eligibility Question, Inclusion Criteria, Exclusion Criteria

https://www.gsk-clinicalstudyregister.com/study/101998#rs Study ID:101998 Clinical Study ID :101998 Study Title :A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data :Study Listed on ClinicalStudyDataRequest.com Sponsor :GlaxoSmithKline Sponsor Identification Number :TRX101998 Collaborators :N/A Phase :Phase 3 Study Recruitment Status :Completed Generic Name :sumatriptan Trade Name :Imitrex ,Imiject ,Imigran Study Indication :Migraine Disorders This form asks for the inclusion and exclusion criteria of the study and should be filled out at the screening visit.

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Serious Adverse Event Notification Form

- 04/02/19 - 1 modulo, 15 itemgroups, 61 elementi, 1 linguaggio

Itemgroups: 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: 101198 Clinical Study ID: 101198 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders 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. • Check that either ’Yes’ or ’no’ box at the top of the page has been completed. • Start dates must be provided for the reporting of serious adverse event data. If the exact date is not known, liaise with the investigator to ensure that a best estimate is provided. • Ensure that no medical or investigational procedures are captured on Serious Adverse Events pages. • Death should not be recorded as an SAE but should be recorded as the outcome of an SAE. The condition that resulted in the death should be recorded as the SAE. • Confirm that any SAEs marked as Recovering/Resolving or Not recovered/Not resolved have been followed up for details of resolution. • If the subject was withdrawn from the study due to an SAE, confirm that the following variables are consistent for the SAE which resulted in withdrawal: • If investigational product was permanently withdrawn due to an adverse event ... • ’Primary Reason for Withdrawal’ on the Study Conclusion page is recorded as ’Adverse Event’ • If the subject was withdrawn from the study for an adverse event ... • ’Withdrawal’ on the SAE page is recorded as ’Yes’. • ’Action Taken with Investigational Product(s) as a Result of the SAE’ on the SAE page is recorded as ’Investigational Product Withdrawn’. 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.

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dbGaP phs000304 Genes and Blood Clotting Study (GABC) - pht004468.v1.p1

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