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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Meal

- 12.11.19 - 1 Formular, 2 Itemgruppen, 8 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Meal
Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form is used to record details about the meal the subject consumed at Visit 2.

Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080 - Screening - Medications of special Interest; RLS Treatment Medications; Alcohol and Caffeine Intake; Current Tobacco Use; Restless Legs Syndrome History; International RLS Study Group Diagnostic Criteria; Subject's Food Intake; 12-Lead ECG

- 12.02.19 - 1 Formular, 12 Itemgruppen, 38 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Medication of special Interest , Medication of special Interest, Prior RLS Treatment Medications, Prior RLS Treatment Medications , Alcohol intake, Caffeine Intake, Current Tobacco Use, Restless Legs Syndrome History, International Restless Leg Syndrome Study Group (IRLSSG) Diagnostic Criteria, Subject's Food Intake, 12-Lead ECG
Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 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

visit week 36 food intake Ropinirole CR Ropinirole IR Monotherapy 101468/168

- 17.10.17 - 1 Formular, 3 Itemgruppen, 15 Datenelemente, 1 Sprache
Itemgruppen: administrative data, food intake before PK sampling, food intake on day of PK sampling
Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy 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: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

visit week 30 food intake Ropinirole CR Ropinirole IR Monotherapy 101468/168

- 17.10.17 - 1 Formular, 3 Itemgruppen, 15 Datenelemente, 1 Sprache
Itemgruppen: administrative data, food intake before PK sampling, food intake on day of PK sampling
Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy 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: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

visit week 32 food intake Ropinirole CR Ropinirole IR Monotherapy 101468/168

- 17.10.17 - 1 Formular, 3 Itemgruppen, 15 Datenelemente, 1 Sprache
Itemgruppen: administrative data, food intake before PK sampling, food intake on day of PK sampling
Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy 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: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

visit week 20 food intake Ropinirole CR Ropinirole IR Monotherapy 101468/168

- 16.10.17 - 1 Formular, 3 Itemgruppen, 15 Datenelemente, 1 Sprache
Itemgruppen: administrative data, food intake before PK sampling, food intake on day of PK sampling
Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy 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: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

visit week 16 food intake Ropinirole CR Ropinirole IR Monotherapy 101468/168

- 16.10.17 - 1 Formular, 3 Itemgruppen, 15 Datenelemente, 1 Sprache
Itemgruppen: administrative data, food intake before PK sampling, food intake on day of PK sampling
Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy 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: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

visit week 14 food intake Ropinirole CR Ropinirole IR Monotherapy 101468/168

- 20.09.17 - 1 Formular, 3 Itemgruppen, 15 Datenelemente, 1 Sprache
Itemgruppen: administrative data, food intake before PK sampling, food intake on day of PK sampling
Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy 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: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 12 101468/169 NCT00381472

- 17.09.17 - 1 Formular, 21 Itemgruppen, 65 Datenelemente, 1 Sprache
Itemgruppen: DIARY INFORMATION, General Information, SUBJECT CONTINUATION, ADVERSE EVENTS PROMPT, CONCOMITANT MEDICATION PROMPT, L-DOPA MEDICATION CHANGES, VITAL SIGNS, SUBJECT’S FOOD INTAKE DAY BEFORE PK SAMPLING, SUBJECT’S FOOD INTAKE ON THE DAY OF PK SAMPLING, PHARMACOKINETICS - BLOOD, CLINICAL GLOBAL IMPRESSION, UNIFIED PARKINSONS DISEASE RATING SCALE, PARKINSON’S DISEASE SLEEP SCALE, BECK DEPRESSION INVENTORY, EPWORTH SLEEPINESS SCALE, PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE (PDQ-39), INVESTIGATIONAL PRODUCT, COMPLIANCE, DISPENSING, DIARY CARD, CONTINUATION
Study ID: 101468/169 Clinical Study ID: 101468/169 Study Title:A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00381472 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Parkinson Disease This is the Week 12 form.

GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 16 101468/169 NCT00381472

- 17.09.17 - 1 Formular, 16 Itemgruppen, 57 Datenelemente, 1 Sprache
Itemgruppen: DIARY INFORMATION, General Information, SUBJECT CONTINUATION, ADVERSE EVENTS PROMPT, CONCOMITANT MEDICATION PROMPT, L-DOPA MEDICATION CHANGES, VITAL SIGNS, SUBJECT’S FOOD INTAKE DAY BEFORE PK SAMPLING, SUBJECT’S FOOD INTAKE ON THE DAY OF PK SAMPLING, PHARMACOKINETICS - BLOOD, CLINICAL GLOBAL IMPRESSION, INVESTIGATIONAL PRODUCT, COMPLIANCE, DISPENSING, DIARY CARD, CONTINUATION
Study ID: 101468/169 Clinical Study ID: 101468/169 Study Title:A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00381472 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Parkinson Disease This is the Week 16 form.

GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 20 101468/169 NCT00381472

- 17.09.17 - 1 Formular, 16 Itemgruppen, 57 Datenelemente, 1 Sprache
Itemgruppen: DIARY INFORMATION, General Information, SUBJECT CONTINUATION, ADVERSE EVENTS PROMPT, CONCOMITANT MEDICATION PROMPT, L-DOPA MEDICATION CHANGES, VITAL SIGNS, SUBJECT’S FOOD INTAKE DAY BEFORE PK SAMPLING, SUBJECT’S FOOD INTAKE ON THE DAY OF PK SAMPLING, PHARMACOKINETICS - BLOOD, CLINICAL GLOBAL IMPRESSION, INVESTIGATIONAL PRODUCT, COMPLIANCE, DISPENSING, DIARY CARD, CONTINUATION
Study ID: 101468/169 Clinical Study ID: 101468/169 Study Title:A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00381472 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Parkinson Disease This is the Week 20 form.

Visit 5 Meal Data [ML_2] NCT01117584

- 28.01.17 - 1 Formular, 1 Itemgruppe, 2 Datenelemente, 1 Sprache
Itemgruppe: General Information
NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

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