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

- 20/09/2021 - 1 Formulário, 2 Grupos de itens, 12 Elementos de dados, 1 Idioma

Grupos de itens: 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.

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

- 17/09/2021 - 9 Formulários, 2 Grupos de itens, 13 Elementos de dados, 1 Idioma

Grupos de itens: 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 Grupos de itens 14 Elementos de dados

Vital signs descirptions

1 Grupo de itens 11 Elementos de dados

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

- 17/09/2021 - 4 Formulários, 11 Grupos de itens, 41 Elementos de dados, 1 Idioma

Grupos de itens: 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 Grupos de itens 78 Elementos de dados

Subject diary

7 Grupos de itens 30 Elementos de dados

SERIOUS ADVERSE EVENT

2 Grupos de itens 13 Elementos de dados

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

- 16/04/2019 - 1 Formulário, 2 Grupos de itens, 6 Elementos de dados, 1 Idioma

Grupos de itens: 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

- 16/04/2019 - 1 Formulário, 8 Grupos de itens, 55 Elementos de dados, 1 Idioma

Grupos de itens: 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 - Form D

- 15/04/2019 - 1 Formulário, 2 Grupos de itens, 9 Elementos de dados, 1 Idioma

Grupos de itens: 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 - Comments, Missing Data

- 15/04/2019 - 1 Formulário, 3 Grupos de itens, 13 Elementos de dados, 1 Idioma

Grupos de itens: 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 - Predose Meal Recording

- 15/04/2019 - 1 Formulário, 2 Grupos de itens, 9 Elementos de dados, 1 Idioma

Grupos de itens: 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

- 15/04/2019 - 1 Formulário, 2 Grupos de itens, 11 Elementos de dados, 1 Idioma

Grupos de itens: 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.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Dosing Details

- 15/04/2019 - 1 Formulário, 2 Grupos de itens, 8 Elementos de dados, 1 Idioma

Grupos de itens: Administrative data, Dosing Details

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 Dosing Details 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 - Baseline Sign and Symptom

- 15/04/2019 - 1 Formulário, 3 Grupos de itens, 18 Elementos de dados, 1 Idioma

Grupos de itens: Administrative data, No event, Adverse Event

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 Baseline Sign and Symptom form. It has to be filled in for screening.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Smoking History for sessions

- 15/04/2019 - 1 Formulário, 2 Grupos de itens, 6 Elementos de dados, 1 Idioma

Grupos de itens: Administrative data, Smoking history

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 smoking history for sessions form. It has to be filled in for all sessions for each day 1 and day 2.

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