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7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690 - Session 3 Day 2

- 23/10/17 - 1 modulo, 3 itemgroups, 7 elementi, 1 linguaggio
Itemgroups: Administrative Documentation, Clinical Chemistry and Haematology, Urinalysis
Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy 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: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690 - Session 3 Day 1 Pre-Dose

- 23/10/17 - 1 modulo, 4 itemgroups, 11 elementi, 1 linguaggio
Itemgroups: Administrative Documentation, Urine Pregnancy Test, Clinical Chemistry and Haematology, Urinalysis
Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy 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: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690 - Session 2 Day 2 Unscheduled

- 23/10/17 - 1 modulo, 3 itemgroups, 7 elementi, 1 linguaggio
Itemgroups: Administrative Documentation, Clinical Chemistry and Haematology, Urinalysis
Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy 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: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690 - Session 2Day 2

- 23/10/17 - 1 modulo, 3 itemgroups, 7 elementi, 1 linguaggio
Itemgroups: Administrative Documentation, Clinical Chemistry and Haematology, Urinalysis
Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy 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: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690 - Screening; Laboratory Collections

- 18/10/17 - 1 modulo, 7 itemgroups, 20 elementi, 1 linguaggio
Itemgroups: Administrative Documentation, Estradiol | FSH, Clinical Chemistry and Haematology, Urinanalysis, Drug Screening (Urine), HIV and Hepatitis B & C, Pregnancy Test
Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy 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: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690 - Screening Laboratory Collections

- 18/10/17 - 1 modulo, 7 itemgroups, 20 elementi, 1 linguaggio
Itemgroups: Administrative Documentation, Estradiol | FSH, Clinical Chemistry and Haematology, Urinanalysis, Drug Screening (Urine), HIV and Hepatitis B & C, Pregnancy Test
Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy 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: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

Follow-Up GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18/10/17 - 1 modulo, 8 itemgroups, 14 elementi, 1 linguaggio
Itemgroups: General Information, RLS RATING SCALE, VITAL SIGNS, MEDICAL PROCEDURES, CONCOMITANT MEDICATION, ADVERSE EXPERIENCES, LABORATORY EVALUATION, URINE DIPSTICK
Study ID: 101468/190 Clinical Study ID: SKF-101468/190 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome This is the mandatory 7 day follow-up assessment form.

Week 12 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18/10/17 - 1 modulo, 11 itemgroups, 18 elementi, 1 linguaggio
Itemgroups: STUDY MEDICATION RECORD SINCE LAST VISIT, CHECK FOR STUDY CONTINUATION, RLS RATING SCALE, PATIENT RATED SCALES, VITAL SIGNS, MEDICAL PROCEDURES, CONCOMITANT MEDICATION, ADVERSE EXPERIENCES, LABORATORY EVALUATION, URINE DIPSTICK, CLINICAL GLOBAL IMPRESSION
Study ID: 101468/190 Clinical Study ID: SKF-101468/190 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome This is the Week 12 form.

Early Withdrawal GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18/10/17 - 1 modulo, 10 itemgroups, 18 elementi, 1 linguaggio
Itemgroups: STUDY MEDICATION RECORD SINCE LAST VISIT, RLS RATING SCALE, PATIENT RATED SCALES, VITAL SIGNS, MEDICAL PROCEDURES, CONCOMITANT MEDICATION, ADVERSE EXPERIENCES, LABORATORY EVALUATION, URINE DIPSTICK, CLINICAL GLOBAL IMPRESSION
Study ID: 101468/190 Clinical Study ID: SKF-101468/190 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome This is the Early Withdrawal form.

Screening Repeat Tests GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18/10/17 - 1 modulo, 5 itemgroups, 11 elementi, 1 linguaggio
Itemgroups: General Information, ELECTROCARDIOGRAM (12 LEAD), PHYSICAL EXAMINATION, LABORATORY EVALUATION, URINE DIPSTICK
Study ID: 101468/190 Clinical Study ID: SKF-101468/190 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome This is the Screening Repeat Tests form.

26072_GSK Ropinirole in Patients Suffering from Restless Legs Syndrome follow-up 101468/190 - GSK Ropinirole in Patients Suffering from Restless Legs Syndrome follow-up 101468/190

- 11/10/17 - 1 modulo, 8 itemgroups, 14 elementi, 1 linguaggio
Itemgroups: General Information, RLS RATING SCALE, VITAL SIGNS, MEDICAL PROCEDURES, CONCOMITANT MEDICATION, ADVERSE EXPERIENCES, LABORATORY EVALUATION, URINE DIPSTICK
Study ID: 101468/190 Clinical Study ID: SKF-101468/190 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome This is the mandatory 7 day follow-up assessment form.

Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 10/10/17 - 1 modulo, 18 itemgroups, 72 elementi, 1 linguaggio
Itemgroups: Concomitant medication, Adverse event, Patient diary, 12-lead electrocardiogram report, orthostatic blood pressure / Pulse, Pregnancy test, Physical examination, Hematology Laboratory evaluation, Hematology Laboratory evaluation, Serum Laboratory evaluation, Serum laboratory evaluation, Urinalysis, Dip stick analysis, Microscopic analysis, Overall urinalysis assessment, Study Completion Part A, Study Completion Part B, Investigator signature
Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects 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

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