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Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Randomisation Number; Investigational Product; Treatment Confirmation

- 17/06/2020 - 1 Formulaire, 4 Groupes Item, 7 Eléments de données, 1 Langue
Groupes Item: Administrative, Randomisation Number, Investigational Product, Treatment Confirmation
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396 - Investigational Product, Treatment Confirmation, Randomisation-Number

- 11/10/2018 - 1 Formulaire, 4 Groupes Item, 9 Eléments de données, 1 Langue
Groupes Item: Administrative Data, Investigational Product, Treatment Confirmation, Randomisation Number (Only Period 1)
This ODM file contains the form to document the investigational product, the treatment confirmation and the randomisation-number. To be assessed at Day 1 of Period 1 and 2 (randomisation number only at Period 1). Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet 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; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Investigational Product – IV Dosing Week 32 Mepolizumab HES NCT00086658 - Investigational Product – IV Dosing Week 32

- 12/07/2017 - 1 Formulaire, 1 Groupe Item, 6 Eléments de données, 1 Langue
Groupe Item: Investigational Product Dose Intravenous
Study part: Investigational Product – IV Dosing Week 32. A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Investigational Product – IV Dosing Week 28 Mepolizumab HES NCT00086658 - Investigational Product – IV Dosing Week 28

- 12/07/2017 - 1 Formulaire, 1 Groupe Item, 6 Eléments de données, 1 Langue
Groupe Item: Investigational Product Dose Intravenous
Study part: Investigational Product – IV Dosing Week 28. A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Investigational Product – IV Dosing Week 24 Mepolizumab HES NCT00086658 - Investigational Product – IV Dosing Week 24

- 12/07/2017 - 1 Formulaire, 1 Groupe Item, 6 Eléments de données, 1 Langue
Groupe Item: Investigational Product Dose Intravenous
Study part: Investigational Product – IV Dosing Week 24. A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Investigational Product – IV Dosing Week 20 Mepolizumab HES NCT00086658 - Investigational Product – IV Dosing Week 20

- 12/07/2017 - 1 Formulaire, 1 Groupe Item, 6 Eléments de données, 1 Langue
Groupe Item: Investigational Product Dose Intravenous
Study part: Investigational Product – IV Dosing Week 20. A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Investigational Product – IV Dosing Week 16 Mepolizumab HES NCT00086658 - Investigational Product – IV Dosing Week 16

- 12/07/2017 - 1 Formulaire, 1 Groupe Item, 6 Eléments de données, 1 Langue
Groupe Item: Investigational Product Dose Intravenous
Study part: Investigational Product – IV Dosing Week 16. A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Investigational Product – IV Dosing Week 12 Mepolizumab HES NCT00086658 - Investigational Product – IV Dosing Week 12

- 10/07/2017 - 1 Formulaire, 1 Groupe Item, 6 Eléments de données, 1 Langue
Groupe Item: Investigational Product Dose Intravenous
Study part: Investigational Product – IV Dosing Week 12. A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Investigational Product – IV Dosing Week 8 Mepolizumab HES NCT00086658 - Investigational Product – IV Dosing Week 8

- 09/07/2017 - 1 Formulaire, 1 Groupe Item, 7 Eléments de données, 1 Langue
Groupe Item: Investigational Product Dose Intravenous
Study part: Investigational Product – IV Dosing Week 8. A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Investigational Product – IV Dosing Week 4 Mepolizumab HES NCT00086658 - Investigational Product – IV Dosing Week 4

- 11/06/2017 - 1 Formulaire, 1 Groupe Item, 6 Eléments de données, 1 Langue
Groupe Item: Investigational Product Dose Intravenous
Study part: Investigational Product – IV Dosing Week 4. A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Investigational Product – IV Dosing Day 1 Post- Infection Mepolizumab HES NCT00086658 - Investigational Product – IV Dosing Day 1 Post- Infection

- 11/06/2017 - 1 Formulaire, 1 Groupe Item, 6 Eléments de données, 1 Langue
Groupe Item: Investigational Product Dose Intravenous
Study part: Investigational Product – IV Dosing Day 1 Post- Infection. A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Investigational product, Randomisation Number

- 24/02/2020 - 1 Formulaire, 5 Groupes Item, 17 Eléments de données, 1 Langue
Groupes Item: Administrative data, Randomisation Number, Investigational product container number, Investigational product (Dose), Investigational product (Dose between study visits)
Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the Investigational product form. It has to be filled in for V2b, V3, V4 and V5. The document also contains the Randomisation Number form. It has to be filled in for V2b.

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