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Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course 1 (Day 8 ) - Vital Signs; Hematology; Administration of Study Medications

- 28/08/2019 - 1 Formulário, 7 Grupos de itens, 44 Elementos de dados, 1 Idioma
Grupos de itens: Administrative, Day 8 Vital Signs, Hematology, Hematology, Day 8 Administration of Study Medications, Topotecan Administration, Gemicitabine Administration
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course 1 (Day 1 ) - Vital Signs; Administration of Study Medications

- 28/08/2019 - 1 Formulário, 4 Grupos de itens, 24 Elementos de dados, 1 Idioma
Grupos de itens: Administrative, Day 1 Vital Signs, Topotecan Administration, Gemcitabine Administration
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine (Study ID: 105377) - Visit 1 - Randomisation Number; 12-Lead ECG; 12-Lead ECG Abnormalities; Vital Signs; Investigational Product; Treatment Confirmation; Electronically Transferred Lab Data; Pharmacokinetics Blood

- 14/08/2019 - 1 Formulário, 12 Grupos de itens, 46 Elementos de dados, 1 Idioma
Grupos de itens: Date of Visit/ Assessment , Randomisation, 12-Lead ECG, 12-Lead ECG Abnormalities, Vital Signs, Investigational Product, Treatment Confirmation, Electronically Transferred Lab Data , Pharmacokinetics Blood Pre-36h (Lamotrigine) - Dosing Date and Time, Pharmacokinetics Blood Pre-36h (Lamotrigine), Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Dosing Date and Time, Pharmacokinetics Blood 48h - 144h (Lamotrigine)
Study ID: 105377 Clinical Study ID: 105377 Study Title: A randomised, open-label, parallel-group design study to evaluate the pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Epilepsy

Evaluation of Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects NCT00989625 - Dose - Randomisation Number; Investigational Product

- 04/08/2019 - 1 Formulário, 2 Grupos de itens, 7 Elementos de dados, 1 Idioma
Grupos de itens: Randomisation Number, Investigational Product
Study ID: 108504 Clinical Study ID: 108504 Study Title: An Open Label, Single Dose, Randomised, Parallel Group Pharmacokinetic Study to Evaluate a Combination Product Containing Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects Administered at Three Doses. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989625 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: This is a pharmacokinetic study (Treximet) Trade Name: Naproxen Sodium and Sumatriptan Study Indication: Migraine Disorders

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Day 1 - Investigational Product; 12-Lead ECG; Vital Signs

- 04/08/2019 - 1 Formulário, 31 Grupos de itens, 176 Elementos de dados, 1 Idioma
Grupos de itens: Date of Visit, Investigational Product, 12-Lead ECG Dosing date/time, 12-Lead ECG - Predose, 12-Lead ECG - 1 Hour, 12-Lead ECG - 2 Hour , 12-Lead ECG - 3 Hour, 12-Lead ECG - 5 Hour , 12-Lead ECG - 8 Hour, 12-Lead ECG - 24 Hour , 12-Lead ECG - 36 Hour, 12-Lead ECG - 48 Hour , 12-Lead ECG - Extra Scheduled Assessments Entry, Vital Signs Predose - Semi-Supine, Vital Signs - Dosing Date and Time, Vital Signs Pre-dose - Standing, Vital Signs 1 Hour - Semi-supine, Vital Signs 1 Hour - Standing , Vital Signs 2 Hour - Semi-supine , Vital Signs 2 Hour - Standing , Vital Signs 5 Hour - Semi-supine, Vital Signs 5 Hour - Standing , Vital Signs 8 Hour - Semi-supine, Vital Signs 8 Hour - Standing , Vital Signs 24 Hour - Semi-supine , Vital Signs 24 Hour - Standing, Vital Signs 36 Hour - Semi-supine, Vital Signs 36 Hour - Standing, Vital Signs 48 Hour - Semi-supine, Vital Signs 48 Hour - Standing , Vital Signs - Extra Scheduled Assessments Entry
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Liver Event - Liver Events; Investigational Product (Liver); Pharmacokinetics (Liver); Medical Conditions; Alcohol Intake (Liver Alcohol); Liver Imaging; Liver Biopsy

- 04/08/2019 - 1 Formulário, 11 Grupos de itens, 103 Elementos de dados, 1 Idioma
Grupos de itens: Date of visit/ date of assessment, Liver Events, Investigational Product (Liver), Pharmacokinetics (Liver PK), Medical Conditions (Liver), Drug related liver disease conditions, Other liver disease conditions, Other medical conditions, Alcohol intake, Liver imaging, Liver Biopsy
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Liver Events; Investigational Product (Liver); Alcohol Intake (Liver Alcohol); Medical Conditions; Pharmacokinetics (Liver); Liver Biopsy; Liver Imaging

- 02/08/2019 - 1 Formulário, 10 Grupos de itens, 102 Elementos de dados, 1 Idioma
Grupos de itens: Liver Events, Investigational Product (Liver) , Alcohol intake, Medical Conditions (Liver), Drug related liver disease conditions, Other liver disease conditions, Other medical conditions, Pharmacokinetics (Liver PK), Liver Biopsy, Liver imaging
Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

SB-681323 in ALI/ARDS risk patients - NCT00996840 - Investigational Product - IV Dosing, Randomisation, Cohort Assignment

- 20/07/2019 - 1 Formulário, 6 Grupos de itens, 18 Elementos de dados, 1 Idioma
Grupos de itens: Administrative Data, Administration, Administration post interruption, Investigational Product Container Number, Treatment Confirmation, Randomisation Number
Study ID: 111592 Clinical Study ID: 111592 Study Title: A Randomized, Double-blind, Placebo-controlled, Doseescalation Study to Assess the Anti-inflammatory Activity, Efficacy, and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury or ARDS Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996840 See https://clinicaltrials.gov/ct2/show/NCT00996840 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, SB-681323 Trade Name: N/A Study Indication: Lung Injury, Acute The primary objective of this phase 2 trial is to evaluate the safety and tolerability of intravenous dilmapimod/SB-681323 given in escalating dosages and over different intervals for three days in trauma patients at risk for the development of ALI or ARDS. This study consists of Screening, infusion of dilmapimod/SB-681323 on days 1-3, examination/sampling up to early day 5 (denoted as "Day 3 - 48 hrs") and a Follow-up on day 7. There are four cohorts, cohorts 1 and 3 receive the medication (or placebo) infusion over 4 hours, cohorts 2 and 4 over 24 hours. This form contains details on the administration of the investigational product and is to be filled in at Day 1, 2 and 3. Additionally, this form also contains Randomisation information and the assignment of the participant to one of the four cohorts for/prior to the first medication administration.

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Cancer and Non-Cancer related surgical Procedures; Investigational Product; Blood Products and Blood Supportive Care Products; Date of Visit/ Assessment; Unscheduled Lesion Assessment; Follow-Up; Follow-Up Anti-Cancer Therapy; Follow-Up Radiotherapy

- 29/05/2019 - 1 Formulário, 9 Grupos de itens, 54 Elementos de dados, 1 Idioma
Grupos de itens: Prior Cancer and Non-Cancer related surgical procedures, Investigational Product, Investigational Product - Dose Modifications, Blood Products and Blood Supportive Care Products, Date of visit/ Assessment, Unscheduled Lesion Assessment, Follow-Up, Follow-Up Anti-Cancer Therapy, Follow-Up Anti-Cancer Radiotherapy
Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Death; Study Conclusion; Pharmacogenetic Research Withdrawal of Consent; Pregnancy Information; Investigatoinal Product Discontinuation; Investigational Product Compliance - Pazopanib; Log Status

- 23/05/2019 - 1 Formulário, 7 Grupos de itens, 26 Elementos de dados, 1 Idioma
Grupos de itens: Death, Study Conclusion, Pharmacogenetic Research Withdrawal of Consent, Pregnancy Information, Investigational Product Discontinuation, Investigational Product Compliance, Log Status
Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Week 36 - Vital Signs; Local Laboratory - Haematology, Clinical Chemistry; Liver Assessment; Laboratory - Thyroid Function Test; Urinalysis; Urinalysis - Local: 24h Protein Details; Target Lesion Assessments; Confirmatory Response; Investigational Product Compliance - Pazopanib, 12-Lead ECG

- 22/05/2019 - 1 Formulário, 13 Grupos de itens, 188 Elementos de dados, 1 Idioma
Grupos de itens: Date of visit/ assessment, Vital Signs, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Liver Assessment, Local Laboratory - Thyroid Function, Local Laboratory - Urinalysis, Urinalysis - Local: 24 hour Protein Details, Target Lesion Summary, Confirmatory Response - Response Summary, Confirmatory Response - New Lesions, Investigatoinal Product Compliance - Pazopanib, 12-Lead ECG
Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Week 30 - Vital Signs; Local Laboratory - Haematology, Clinical Chemistry; Liver Assessment; Local Laboratory - Thyroid Function Test; Urinalysis; Urinalysis - Local: 24h Protein Details; Investigational Product Compliance - Pazopanib; Target Lesion Assessments; Confirmatory Response

- 22/05/2019 - 1 Formulário, 12 Grupos de itens, 182 Elementos de dados, 1 Idioma
Grupos de itens: Date of visit/ assessment, Vital Signs, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Liver Assessment, Local Laboratory - Thyroid Function , Local Laboratory - Urinalysis, Urinalysis - Local: 24 hour Protein Details, Investigatoinal Product Compliance - Pazopanib, Target Lesion Summary, Confirmatory Response - Response Summary, Confirmatory Response - New Lesions
Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

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