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

- 20.09.21 - 1 Formular, 2 Itemgruppen, 12 Datenelemente, 1 Sprache
Itemgruppen: 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

- 20.09.21 - 1 Formular, 2 Itemgruppen, 5 Datenelemente, 1 Sprache
Itemgruppen: 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

- 20.09.21 - 1 Formular, 3 Itemgruppen, 28 Datenelemente, 1 Sprache
Itemgruppen: 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

- 20.09.21 - 1 Formular, 4 Itemgruppen, 18 Datenelemente, 1 Sprache
Itemgruppen: 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

- 17.09.21 - 9 Formulare, 2 Itemgruppen, 13 Datenelemente, 1 Sprache
Itemgruppen: 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 Itemgruppen 14 Datenelemente

STATUS OF TREATMENT BLIND

3 Itemgruppen 14 Datenelemente

Investigator INSTRUCTIONS

1 Itemgruppe 1 Datenelement

INVESTIGATIONAL PRODUCT

1 Itemgruppe 8 Datenelemente

CONCOMITANT MEDICATIONS

1 Itemgruppe 10 Datenelemente

Vital signs descirptions

1 Itemgruppe 11 Datenelemente

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

- 17.09.21 - 4 Formulare, 11 Itemgruppen, 41 Datenelemente, 1 Sprache
Itemgruppen: 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 Itemgruppen 78 Datenelemente

Subject diary

7 Itemgruppen 30 Datenelemente

SERIOUS ADVERSE EVENT

2 Itemgruppen 13 Datenelemente

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

- 16.04.19 - 1 Formular, 8 Itemgruppen, 55 Datenelemente, 1 Sprache
Itemgruppen: 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 - Follow-Up Physical Examination

- 16.04.19 - 1 Formular, 2 Itemgruppen, 6 Datenelemente, 1 Sprache
Itemgruppen: 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 - Comments, Missing Data

- 15.04.19 - 1 Formular, 3 Itemgruppen, 13 Datenelemente, 1 Sprache
Itemgruppen: 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

- 15.04.19 - 1 Formular, 2 Itemgruppen, 9 Datenelemente, 1 Sprache
Itemgruppen: 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

- 15.04.19 - 1 Formular, 2 Itemgruppen, 9 Datenelemente, 1 Sprache
Itemgruppen: 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

- 15.04.19 - 1 Formular, 2 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: 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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