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Dose strength equivalence of ropinirole CR in healthy adults Screening 101468/219 - Screening Dose strength equivalence of ropinirole CR in healthy adults 101468/219

- 09.10.17 - 1 Formular, 3 Itemgruppen, 28 Datenelemente, 1 Sprache
Itemgruppen: Demography, Inclusion Criteria, Exclusion Criteria
Study ID: 101468/219 Clinical Study ID: 101468/219 Study Title:An open label, randomised, five-way crossover single-dose pharmacokinetic study to assess dosage strength equivalence of ropinirole CR in healthy male and female volunteers 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: Requip Study Indication : Parkinson Disease Documentation part: Screening

Dose strength equivalence of ropinirole CR in healthy adults Form D 101468/219 - Form D Dose strength equivalence of ropinirole CR in healthy adults 101468/219

- 09.10.17 - 1 Formular, 1 Itemgruppe, 4 Datenelemente, 1 Sprache
Itemgruppe: Form D
Study ID: 101468/219 Clinical Study ID: 101468/219 Study Title:An open label, randomised, five-way crossover single-dose pharmacokinetic study to assess dosage strength equivalence of ropinirole CR in healthy male and female volunteers 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: Requip Study Indication : Parkinson Disease Documentation part: Form D

Exclusion Criteria second visit Ropinirole Case Report Form GSK RRL100013

- 05.10.17 - 1 Formular, 2 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Exclusion Criteria
Exclusion Criteria second visit Ropinirole Case Report Form Concomitant Medication 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

Exclusion Criteria 1 Ropinirole Case Report Form GSK RRL100013

- 05.10.17 - 1 Formular, 2 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Exclusion Criteria
Exclusion Criteria 1 Ropinirole Case Report 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

Inclusion Ropinirole Case Report Form GSK RRL10001

- 05.10.17 - 1 Formular, 1 Itemgruppe, 7 Datenelemente, 1 Sprache
Itemgruppe: Inclusion Criteria
Inclusion Ropinirole Case Report Form Concomitant Medication 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

Neurological Examination Early Withdrawal Ropinirole Case Report Form GSK RRL100013

- 01.10.17 - 1 Formular, 1 Itemgruppe, 19 Datenelemente, 1 Sprache
Itemgruppe: Neurological Examination
Neurological Examination Early Withdrawal 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

Investigators Statement Ropinirole Case Report Form GSK RRL100013

- 01.10.17 - 1 Formular, 1 Itemgruppe, 8 Datenelemente, 1 Sprache
Itemgruppe: Statement investigator
Investigators Statement 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

Eligibility Question Ropinirole Case Report Form GSK RRL100013

- 30.09.17 - 1 Formular, 3 Itemgruppen, 21 Datenelemente, 1 Sprache
Itemgruppen: Eligibility Question, Inclusion Criteria, Exclusion Criteria
Eligibility Question 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

PRIOR RLS TREATMENT MEDICATIONS Ropinirole Case Report Form GSK RRL100013

- 30.09.17 - 1 Formular, 2 Itemgruppen, 39 Datenelemente, 1 Sprache
Itemgruppen: Concomitant Medications, Other RLS medications
PRIOR RLS TREATMENT MEDICATIONS 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

Dose strength equivalence of ropinirole CR in healthy adults Follow-up Visit 101468/219 - Follow-up Visit Dose strength equivalence of ropinirole CR in healthy adults 101468/219

- 17.08.17 - 1 Formular, 10 Itemgruppen, 63 Datenelemente, 1 Sprache
Itemgruppen: Physical Examination, Pregnancy Test, ECG Monitoring, Vitals Signs, Clinical Chemistry and Haematology, Urinalysis, Adverse Event, Pregnancy Information, Study Conclusion, Investigators Statement
Study ID: 101468/219 Clinical Study ID: 101468/219 Study Title:An open label, randomised, five-way crossover single-dose pharmacokinetic study to assess dosage strength equivalence of ropinirole CR in healthy male and female volunteers 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: Requip Study Indication : Parkinson Disease Documentation part: Follow-up Visit

Dose strength equivalence of ropinirole CR in healthy adults Treatment Period 3 101468/219 - Treatment Period 3 Dose strength equivalence of ropinirole CR in healthy adults 101468/219

- 17.08.17 - 1 Formular, 10 Itemgruppen, 58 Datenelemente, 1 Sprache
Itemgruppen: Predose Checklist, Pregnancy Test, Drug Screening, Alcohol Breath Test, Vitals Signs, Dosing Details, Vital Signs, Domperidone Dosing Details, Blood Sampling, Adverse Event
Study ID: 101468/219 Clinical Study ID: 101468/219 Study Title:An open label, randomised, five-way crossover single-dose pharmacokinetic study to assess dosage strength equivalence of ropinirole CR in healthy male and female volunteers 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: Requip Study Indication : Parkinson Disease Documentation part: Treatment Period 3

Dose strength equivalence of ropinirole CR in healthy adults Treatment Period 2 101468/219 - Treatment Period 2 Dose strength equivalence of ropinirole CR in healthy adults 101468/219

- 17.08.17 - 1 Formular, 10 Itemgruppen, 58 Datenelemente, 1 Sprache
Itemgruppen: Predose Checklist, Pregnancy Test, Drug Screening, Alcohol Breath Test, Vitals Signs, Dosing Details, Vital Signs, Domperidone Dosing Details, Blood Sampling, Adverse Event
Study ID: 101468/219 Clinical Study ID: 101468/219 Study Title:An open label, randomised, five-way crossover single-dose pharmacokinetic study to assess dosage strength equivalence of ropinirole CR in healthy male and female volunteers 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: Requip Study Indication : Parkinson Disease Documentation part: Treatment Period 2

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