ID
33434
Description
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
Mots-clés
Versions (4)
- 01/12/2018 01/12/2018 -
- 08/12/2018 08/12/2018 -
- 25/12/2018 25/12/2018 -
- 10/01/2019 10/01/2019 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
8 décembre 2018
DOI
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Licence
Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434
Medical History
- StudyEvent: ODM
Description
Medical History
Alias
- UMLS CUI-1
- C0262926
Description
Past or Presen Conditions or Surgical Procedures
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [2]
- C0262926
- UMLS CUI [3]
- C0009488
Description
Past and or Present Conditions or Surgical Procedures
Type de données
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
Description
Organ System
Type de données
integer
Alias
- UMLS CUI [1]
- C0678852
Description
If items above are ticked yes, please give details
Type de données
text
Alias
- UMLS CUI [1]
- C2348235
Description
Medical History Continuation
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0549178
Description
Medical History of Seizure, Brain Injury of Predisposition to Seizure
Type de données
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
Description
Medical History of Seizure, Brain Injury of Predisposition to Seizure Comment
Type de données
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
Description
Hypersensitivity to Lamotrigine
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0064636
Description
Hypersensitivity to Lamotrigine Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0064636
- UMLS CUI [2]
- C0947611
Description
Recent Blood Donation
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0005794
- UMLS CUI [1,2]
- C0332185
Description
Recent Blood Donation Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0005794
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2]
- C0947611
Description
Recent Study Participation with Investigational Drug
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013230
Description
Recent Study Participation within Investigational Drug Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [2]
- C0947611
Description
Conclusion
Alias
- UMLS CUI-1
- C1707478
Similar models
Medical History
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
C0543467 (UMLS CUI [2])
C1444637 (UMLS CUI [3,1])
C0009488 (UMLS CUI [3,2])
C0150312 (UMLS CUI [4,1])
C0009488 (UMLS CUI [4,2])
C0549178 (UMLS CUI-2)
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])
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])
C0064636 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C0332185 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C0013230 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C1552089 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,2])