ID

33434

Beschreibung

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains the subjects medical history. It should be filled out at the screening visit, at each treatment period, pre-dose and at the follow-up visit. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Stichworte

Versionen (4)
  1. 01.12.18 01.12.18 -
  2. 08.12.18 08.12.18 -
  3. 25.12.18 25.12.18 -
  4. 10.01.19 10.01.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

8. Dezember 2018

DOI

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Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Englisch

Medical History

1 Formulare  
  1. StudyEvent: ODM
    1. Medical History
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschreibung

Subject Screening No.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0600091
Subject no.
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date Information Collected
Beschreibung

Date Information Collected

Datentyp

date

Alias
UMLS CUI [1,1]
C3244127
UMLS CUI [1,2]
C0011008
Treatment Period
Beschreibung

Treatment Period

Datentyp

integer

Alias
UMLS CUI [1]
C2347804
Medical History
Beschreibung

Medical History

Alias
UMLS CUI-1
C0262926
Any past and/or present conditions/surgical procedures associated with the following?
Beschreibung

Past or Presen Conditions or Surgical Procedures

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0543467
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0009488
Are any past and/or present conditions/surgical procedures associated with the following?
Beschreibung

Past and or Present Conditions or Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0543467
UMLS CUI [3,1]
C1444637
UMLS CUI [3,2]
C0009488
UMLS CUI [4,1]
C0150312
UMLS CUI [4,2]
C0009488
Organ System
Beschreibung

Organ System

Datentyp

integer

Alias
UMLS CUI [1]
C0678852
Specification
Beschreibung

If items above are ticked yes, please give details

Datentyp

text

Alias
UMLS CUI [1]
C2348235
Medical History Continuation
Beschreibung

Medical History Continuation

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0549178
Does the subject have a current or past history of any seizure disorder or brain injury or any condition which predisposes to seizure?
Beschreibung

Medical History of Seizure, Brain Injury of Predisposition to Seizure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0036572
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0270611
UMLS CUI [3,1]
C0220898
UMLS CUI [3,2]
C0036572
Does the subject have a current or past history of any seizure disorder or brain injury or any condition which predisposes to seizure?
Beschreibung

Medical History of Seizure, Brain Injury of Predisposition to Seizure Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0036572
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0270611
UMLS CUI [3,1]
C0220898
UMLS CUI [3,2]
C0036572
UMLS CUI [4]
C0947611
Does the subject have a history of hypersensitivity to lamotrigine?
Beschreibung

Hypersensitivity to Lamotrigine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0064636
Does the subject have a history of hypersensitivity to lamotrigine?
Beschreibung

Hypersensitivity to Lamotrigine Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0064636
UMLS CUI [2]
C0947611
Has the subject donated blood in excess of 500ml within 56 days prior to the first dose of study medication?
Beschreibung

Recent Blood Donation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0332185
Has the subject donated blood in excess of 500ml within 56 days prior to the first dose of study medication?
Beschreibung

Recent Blood Donation Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0332185
UMLS CUI [2]
C0947611
Participation in a trial with and investigational drug within 30 days or 5 half lives (whichever is longer) prior to dosing
Beschreibung

Recent Study Participation with Investigational Drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
Participation in a trial with and investigational drug within 30 days or 5 half lives (whichever is longer) prior to dosing
Beschreibung

Recent Study Participation within Investigational Drug Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
UMLS CUI [2]
C0947611
Conclusion
Beschreibung

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Beschreibung

Staff initials

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Physician's Initials
Beschreibung

Physician's Initials

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
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Ähnliche Modelle

Medical History

1 Formulare
  1. StudyEvent: ODM
    1. Medical History
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Screening No.
Item
Subject Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject no.
integer
C2348585 (UMLS CUI [1])
Date Information Collected
Item
Date Information Collected
date
C3244127 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Treatment Period
integer
C2347804 (UMLS CUI [1])
Treatment Period
Code List
Treatment Period
CL Item
Screening (1)
CL Item
Treatment Period 1 (2)
CL Item
Treatment Period 2 (3)
CL Item
Treatment Period 3 (4)
CL Item
Follow-Up Visit (5)
Item Group
Medical History
C0262926 (UMLS CUI-1)
Past or Presen Conditions or Surgical Procedures
Item
Any past and/or present conditions/surgical procedures associated with the following?
text
C0262926 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
Past and or Present Conditions or Surgical Procedures
Item
Are any past and/or present conditions/surgical procedures associated with the following?
boolean
C0262926 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C1444637 (UMLS CUI [3,1])
C0009488 (UMLS CUI [3,2])
C0150312 (UMLS CUI [4,1])
C0009488 (UMLS CUI [4,2])
Item
Organ System
integer
C0678852 (UMLS CUI [1])
Organ System
Code List
Organ System
CL Item
Cardiovascular system (1)
CL Item
Respiratory system (incl. influenza, asthma) (2)
CL Item
Gastrointestinal system (incl. indigestion, heartburn, bowel disorders, nausea, vomiting, diarrhoea) (3)
CL Item
Renal system (4)
CL Item
Hepatic system (5)
CL Item
Endocrine system/metabolism (6)
CL Item
Neurological system (incl. convulsions, fits, blackouts) (7)
CL Item
Lymphatic system (8)
CL Item
Haematological system (9)
CL Item
Immunological system (incl. allergies, drug hypersensitivity) (10)
CL Item
Musculoskeletal system/connective tissue (11)
CL Item
Dermatological system (12)
CL Item
Genito-urinary system (13)
CL Item
Psychiatric function (14)
CL Item
Other (15)
Specification
Item
Specification
text
C2348235 (UMLS CUI [1])
Item Group
Medical History Continuation
C0262926 (UMLS CUI-1)
C0549178 (UMLS CUI-2)
Medical History of Seizure, Brain Injury of Predisposition to Seizure
Item
Does the subject have a current or past history of any seizure disorder or brain injury or any condition which predisposes to seizure?
boolean
C0262926 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0270611 (UMLS CUI [2,2])
C0220898 (UMLS CUI [3,1])
C0036572 (UMLS CUI [3,2])
Medical History of Seizure, Brain Injury of Predisposition to Seizure Comment
Item
Does the subject have a current or past history of any seizure disorder or brain injury or any condition which predisposes to seizure?
text
C0262926 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0270611 (UMLS CUI [2,2])
C0220898 (UMLS CUI [3,1])
C0036572 (UMLS CUI [3,2])
C0947611 (UMLS CUI [4])
Hypersensitivity to Lamotrigine
Item
Does the subject have a history of hypersensitivity to lamotrigine?
boolean
C0020517 (UMLS CUI [1,1])
C0064636 (UMLS CUI [1,2])
Hypersensitivity to Lamotrigine Comment
Item
Does the subject have a history of hypersensitivity to lamotrigine?
text
C0020517 (UMLS CUI [1,1])
C0064636 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Recent Blood Donation
Item
Has the subject donated blood in excess of 500ml within 56 days prior to the first dose of study medication?
boolean
C0005794 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Recent Blood Donation Comment
Item
Has the subject donated blood in excess of 500ml within 56 days prior to the first dose of study medication?
text
C0005794 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Recent Study Participation with Investigational Drug
Item
Participation in a trial with and investigational drug within 30 days or 5 half lives (whichever is longer) prior to dosing
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Recent Study Participation within Investigational Drug Comment
Item
Participation in a trial with and investigational drug within 30 days or 5 half lives (whichever is longer) prior to dosing
text
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Physician's Initials
Item
Physician's Initials
text
C2986440 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
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