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  2. 2. Routine Documentation
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  6. 6. Patient-Reported Outcome
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190 Search results.

Pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine (Study ID: 105377) - Logs/ Repeats - Electronically Transferred Lab Data; Vital Signs; Pharmacokinetics Blood

- 8/16/19 - 1 form, 3 itemgroups, 10 items, 1 language
Itemgroups: Electronically Transferred Lab Data, Vital signs, Pharmacokinetics Blood (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

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

- 8/14/19 - 1 form, 12 itemgroups, 46 items, 1 language
Itemgroups: 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

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Screen - Date of Visit; Demography, 12-Lead ECG; Vital Signs; Subject Identification; Electronically Transferred Lab Data

- 8/14/19 - 1 form, 8 itemgroups, 34 items, 1 language
Itemgroups: Inform Screening, Subject number, Date of Visit/ Assessment, Demography, 12-Lead ECG, Vital Signs, Subject identification, Electronically Transferred Lab Data
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

Evaluation of Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects NCT00989625 - Dose - Pharmacokinetics Blood (Naproxen); Pharmacokinetics Blood (Sumatriptan)

- 8/8/19 - 1 form, 5 itemgroups, 9 items, 1 language
Itemgroups: Date of visit/assessment, Pharmacokinetics Blood (Naproxen) - Dosing Date and Time, Pharmacokinetics Blood (Naproxen), Pharmacokinetics Blood (Sumatriptan) - Dosing Date and Time , Pharmacokinetics Blood (Sumatriptan)
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 - Summary Holter; Summary Holter Abnormalities; Electronically Transferred Lab Data; Pharmacokinetics Blood; Urinalysis

- 8/4/19 - 1 form, 24 itemgroups, 323 items, 1 language
Itemgroups: Date of Visit, Summary Holter, Summary Holter Abnormalities, Electroniclly Transferred Lab Data - Dosing Date and Time, Electronically Transerred Lab Data - Pre-dose, Electronically Transerred Lab Data - 1 Hour, Electronically Transerred Lab Data - 2 Hour , Electronically Transerred Lab Data - 4 Hour, Electronically Transerred Lab Data - 8 Hour , Electronically Transerred Lab Data - 24 Hour, Electronically Transerred Lab Data - 36 Hour , Electronically Transerred Lab Data - 48 Hour, Electronically Transerred Lab Data - 72 Hour , Pharmacokinetics Blood, Pharmacokinetics Blood - Extra Scheduled Samples Entry , Urinalysis - Dosing Date and Time , Urinalysis Dipstick Details - Pre-Dose, Urinalysis Dipstick Details - 2 Hour Post-Dose, Urinalysis Dipstick Details - 4 Hour Post-Dose , Urinalysis Dipstick Details - 8 Hour Post-Dose , Urinalysis Dipstick Details - 24 Hour Post-Dose , Urinalysis Dipstick Details -36 Hour Post-Dose, Urinalysis Dipstick Details -48 Hour Post-Dose , Urinalysis - Local: Microscopy Details
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 - Logs/ Repeats - Logs and Repeats; Non- Serious Adverse Events; Serious Adverse Events; Concomitant Medication; Electronically Transferred Lab Data; Vital Signs; 12-Lead ECG; ECG Abnormalities; Repeat- Pharmacokinetics Blood - GSK618334

- 8/4/19 - 1 form, 18 itemgroups, 151 items, 1 language
Itemgroups: Logs and Repeats, Logs and Repeats - Adverse event/ Concomitant Medication/ Repeat Assessment Check Questions, Non-serious Adverse Event (AE), Serious Adverse Events (SAE), Serious Adverse Event - Concomitant Medication, Serious Adverse Event - Medical Conditions/ Risk Factors, Serious Adverse Events - Relevant diagnostic results, Serious Adverse Events - Investigational Products, Serious Adverse Events - General narrative comments, Serious Adverse Events - Non clinical, Concomitant Medication, Urinalysis - Local, Electronically Transferred Lab Data, Vital signs - Semi-supine, Vital Signs - Standing, 12-Lead ECG, ECG Abnormalities, Repeat Pharmacokinetics Blood - GSK618334
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

- 8/4/19 - 1 form, 11 itemgroups, 103 items, 1 language
Itemgroups: 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

- 8/2/19 - 1 form, 10 itemgroups, 102 items, 1 language
Itemgroups: 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 - Pharmacokinetics Blood

- 7/20/19 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Administrative Data, Pharmacokinetics Blood
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 is to be filled with data regarding pharmacokinetic samples, taken repeatedly on Day 1, 2 and 3 (times vary depending on cohort), and can also be used for repeat analyses.

Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146 - Dosing Session 3

- 6/23/19 - 1 form, 6 itemgroups, 23 items, 1 language
Itemgroups: Administrative documentation, Prganancy Tests, Drug abuse, Vital Signs, Pharmacokinetic aspects, Sampling, Experimental drug
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

Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146 - Dosing Session 2

- 6/23/19 - 1 form, 6 itemgroups, 23 items, 1 language
Itemgroups: Administrative documentation, Prganancy Tests, Drug abuse, Vital Signs, Pharmacokinetic aspects, Sampling, Experimental drug
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

Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146 - Dosing Session 1

- 6/23/19 - 1 form, 6 itemgroups, 24 items, 1 language
Itemgroups: Administrative documentation, Prganancy Tests, Drug abuse, Vital Signs, Pharmacokinetic aspects, Sampling, Experimental drug
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