Keywords
Clinical Trial ×
Psychiatry ×
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Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
Selected data models

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- 11/12/19 - 1 form, 9 itemgroups, 28 items, 1 language
Itemgroups: Administrative Data, General information on possible suicidality-related AE, Suicidality-Related Adverse Event description, Possible suicidality-related adverse event causes, Psychiatric History, Psycho-social stressors, Suicidal ideation, Suicidal behaviour during study, Medical and psychiatric treatment
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 any possible suicidality-related adverse events happening during the study. The event must also be reported on the Adverse Events Form (Non-serious or Serious Adverse Events form as applicable) using the same terminology. Record only 1 event per form.
- 8/4/19 - 1 form, 31 itemgroups, 176 items, 1 language
Itemgroups: Date of Visit, Investigational Product, 12-Lead ECG Dosing date/time, 12-Lead ECG - Predose, 12-Lead ECG - 1 Hour, 12-Lead ECG - 2 Hour , 12-Lead ECG - 3 Hour, 12-Lead ECG - 5 Hour , 12-Lead ECG - 8 Hour, 12-Lead ECG - 24 Hour , 12-Lead ECG - 36 Hour, 12-Lead ECG - 48 Hour , 12-Lead ECG - Extra Scheduled Assessments Entry, Vital Signs Predose - Semi-Supine, Vital Signs - Dosing Date and Time, Vital Signs Pre-dose - Standing, Vital Signs 1 Hour - Semi-supine, Vital Signs 1 Hour - Standing , Vital Signs 2 Hour - Semi-supine , Vital Signs 2 Hour - Standing , Vital Signs 5 Hour - Semi-supine, Vital Signs 5 Hour - Standing , Vital Signs 8 Hour - Semi-supine, Vital Signs 8 Hour - Standing , Vital Signs 24 Hour - Semi-supine , Vital Signs 24 Hour - Standing, Vital Signs 36 Hour - Semi-supine, Vital Signs 36 Hour - Standing, Vital Signs 48 Hour - Semi-supine, Vital Signs 48 Hour - Standing , Vital Signs - Extra Scheduled Assessments Entry
- 8/4/19 - 1 form, 24 itemgroups, 323 items, 1 language
Itemgroups: Date of Visit, Summary Holter, Summary Holter Abnormalities, Electroniclly Transferred Lab Data - Dosing Date and Time, Electronically Transerred Lab Data - Pre-dose, Electronically Transerred Lab Data - 1 Hour, Electronically Transerred Lab Data - 2 Hour , Electronically Transerred Lab Data - 4 Hour, Electronically Transerred Lab Data - 8 Hour , Electronically Transerred Lab Data - 24 Hour, Electronically Transerred Lab Data - 36 Hour , Electronically Transerred Lab Data - 48 Hour, Electronically Transerred Lab Data - 72 Hour , Pharmacokinetics Blood, Pharmacokinetics Blood - Extra Scheduled Samples Entry , Urinalysis - Dosing Date and Time , Urinalysis Dipstick Details - Pre-Dose, Urinalysis Dipstick Details - 2 Hour Post-Dose, Urinalysis Dipstick Details - 4 Hour Post-Dose , Urinalysis Dipstick Details - 8 Hour Post-Dose , Urinalysis Dipstick Details - 24 Hour Post-Dose , Urinalysis Dipstick Details -36 Hour Post-Dose, Urinalysis Dipstick Details -48 Hour Post-Dose , Urinalysis - Local: Microscopy Details
- 8/4/19 - 1 form, 18 itemgroups, 151 items, 1 language
Itemgroups: Logs and Repeats, Logs and Repeats - Adverse event/ Concomitant Medication/ Repeat Assessment Check Questions, Non-serious Adverse Event (AE), Serious Adverse Events (SAE), Serious Adverse Event - Concomitant Medication, Serious Adverse Event - Medical Conditions/ Risk Factors, Serious Adverse Events - Relevant diagnostic results, Serious Adverse Events - Investigational Products, Serious Adverse Events - General narrative comments, Serious Adverse Events - Non clinical, Concomitant Medication, Urinalysis - Local, Electronically Transferred Lab Data, Vital signs - Semi-supine, Vital Signs - Standing, 12-Lead ECG, ECG Abnormalities, Repeat Pharmacokinetics Blood - GSK618334