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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Prior Medication

- 2021-09-20 - 1 Formulär, 2 Item-grupper, 12 Dataelement, 1 Språk
Item-grupper: Administrative data, Prior Medication
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the prior medication form. It has to be filled in for screening.

Screening demography Ropinirole Case Report Form GSK RRL100013

- 2021-09-20 - 1 Formulär, 2 Item-grupper, 5 Dataelement, 1 Språk
Item-grupper: Administrative Data, demography
Demography Ropinirole Case Report FormStudy ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

Visit 1 inclusion/exclusion criteria starting dose of ropinirole Ropinirole Case Report Form GSK RRL100013

- 2021-09-20 - 1 Formulär, 3 Item-grupper, 28 Dataelement, 1 Språk
Item-grupper: administrative data, Inclusion criteria, exclusion criteria
Inclusion/exclusion criteria Ropinirole Case Report Form GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

Vital Signs Ropinirole Case Report Form GSK RRL100013

- 2021-09-20 - 1 Formulär, 4 Item-grupper, 18 Dataelement, 1 Språk
Item-grupper: Vital Signs, Pre- dose, post dose, post dose
Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

Ropinirole Case Report Form GSK RRL100013 - NON-SERIOUS ADVERSE EVENT

- 2021-09-17 - 9 Formulär, 2 Item-grupper, 13 Dataelement, 1 Språk
Item-grupper: NON-SERIOUS ADVERSE EVENT, NON-SERIOUS ADVERSE EVENTS
Ropinirole Case Report Form GSK RRL100013 GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

Ropinirole Case Report Form GSK RRL100013

3 Item-grupper 14 Dataelement

STATUS OF TREATMENT BLIND

3 Item-grupper 14 Dataelement

Investigator INSTRUCTIONS

1 Item-grupp 1 Dataelement

INVESTIGATIONAL PRODUCT

1 Item-grupp 8 Dataelement

CONCOMITANT MEDICATIONS

1 Item-grupp 10 Dataelement

Vital signs descirptions

1 Item-grupp 11 Dataelement

Ropinirole Case Report Form GSK RRL100013 - Serious Adverse Event (SAE)

- 2021-09-17 - 4 Formulär, 11 Item-grupper, 41 Dataelement, 1 Språk
Item-grupper: Serious Adverse Event (SAE) Section 1, SECTION 2 Seriousness, SECTION 3 Demography Data, SECTION 4, SECTION 5, SECTION 6, SECTION 7, Document section Concomitant Medications, Drug Details, Assessments, Narrative Remarks
Ropinirole Case Report Form GSK RRL100013 GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

PREGNANCY INFORMATION

6 Item-grupper 78 Dataelement

Subject diary

7 Item-grupper 30 Dataelement

SERIOUS ADVERSE EVENT

2 Item-grupper 13 Dataelement

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Follow-Up Physical Examination

- 2019-04-16 - 1 Formulär, 2 Item-grupper, 6 Dataelement, 1 Språk
Item-grupper: Administrative data, Physical Examination
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Follow-Up Physical Examination form. It has to be filled in for follow-up.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Pregnancy Notification Form

- 2019-04-16 - 1 Formulär, 8 Item-grupper, 55 Dataelement, 1 Språk
Item-grupper: Administrative data, Reporter Information, Mother's relevant medical/family history, Father's relevant medical/family history, GSK Drug/Vaccine Information and Concomitant Medications, Current pregnancy information/status, Infant information, Relevant Laboratory Test and Procedures
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Pregnancy Notification Form form. Complete as may sections ofthis 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 of fax (fax preferred) within two weeks ofleaming ofthepregnancy.After delivery complete the remaining sections and fax the form to GSK. Original pages should remain with the subject's Case Report From.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Comments, Missing Data

- 2019-04-15 - 1 Formulär, 3 Item-grupper, 13 Dataelement, 1 Språk
Item-grupper: Administrative data, Comments, Missing Data
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Comments and Missing Data form. It can be filled in for the end of study.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Form D

- 2019-04-15 - 1 Formulär, 2 Item-grupper, 9 Dataelement, 1 Språk
Item-grupper: Administrative data, Form D
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Form D. It can be filled in for the end of study.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Predose Meal Recording

- 2019-04-15 - 1 Formulär, 2 Item-grupper, 9 Dataelement, 1 Språk
Item-grupper: Administrative data, Meal Recording
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Predose Meal Recording form. It has to be filled in for all sessions each for day 1.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Pregnancy Test

- 2019-04-15 - 1 Formulär, 2 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Administrative data, Pregnancy Test
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the pregnancy test form. It has to be filled in for all sessions each for day 1 and for follow-up.

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