ID

33449

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 information about any concomitant medication the subject used during the study. It should be filled out at each 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. 09.12.18 09.12.18 -
  3. 21.01.19 21.01.19 -
  4. 25.01.19 25.01.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

9. 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

Concomitant Medication

1 Formulare  
  1. StudyEvent: ODM
    1. Concomitant Medication
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
Study Visit
Beschreibung

Study Visit

Datentyp

text

Alias
UMLS CUI [1]
C0545082
Concomitant Medication
Beschreibung

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Has the subject taken received prescribed or non-prescribed medication (including vitamins, herbal remedies and antacids) within 7 days prior to the screening day, which in the opinion of the principal/co-investigator, may interfere with the study procedures or comprise safety.
Beschreibung

f yes, record details below. Paracetamol for mild analgesia may be permitted

Datentyp

text

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C3166216
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0013231
UMLS CUI [3,1]
C0332257
UMLS CUI [3,2]
C0042890
UMLS CUI [4,1]
C0332257
UMLS CUI [4,2]
C1360419
UMLS CUI [5,1]
C0332257
UMLS CUI [5,2]
C0003138
Concomitant Medication Details
Beschreibung

Concomitant Medication Details

Alias
UMLS CUI-1
C2347852
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
Start Time
Beschreibung

If known

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C2347852
Medication
Beschreibung

Generic/Brand

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2347852
Dose
Beschreibung

Dose

Datentyp

text

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C2347852
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
Indication
Beschreibung

Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2347852
Medication Ongoing
Beschreibung

Medication Ongoing

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
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

Concomitant Medication

1 Formulare
  1. StudyEvent: ODM
    1. Concomitant Medication
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
Study Visit
text
C0545082 (UMLS CUI [1])
Study Visit
Code List
Study Visit
CL Item
Screening (Screening)
CL Item
Treatment Period 1 (Treatment Period 1)
CL Item
Treatment Period 2 (Treatment Period 2)
CL Item
Treatment Period 3 (Treatment Period 3)
CL Item
Follow-Up Visit (Follow-Up Visit)
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Item
Has the subject taken received prescribed or non-prescribed medication (including vitamins, herbal remedies and antacids) within 7 days prior to the screening day, which in the opinion of the principal/co-investigator, may interfere with the study procedures or comprise safety.
text
C0332185 (UMLS CUI [1,1])
C3166216 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C0332257 (UMLS CUI [3,1])
C0042890 (UMLS CUI [3,2])
C0332257 (UMLS CUI [4,1])
C1360419 (UMLS CUI [4,2])
C0332257 (UMLS CUI [5,1])
C0003138 (UMLS CUI [5,2])
Prescribed or Non-Prescribed Medication, including Vitamins, Herbal Remedies and Antacids
Code List
Has the subject taken received prescribed or non-prescribed medication (including vitamins, herbal remedies and antacids) within 7 days prior to the screening day, which in the opinion of the principal/co-investigator, may interfere with the study procedures or comprise safety.
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
N/A (N/A)
Item Group
Concomitant Medication Details
C2347852 (UMLS CUI-1)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Start Time
Item
Start Time
datetime
C1301880 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Medication
Item
Medication
text
C0013227 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Units
Item
Units
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Medication Ongoing
Item
Medication Ongoing
boolean
C2826666 (UMLS CUI [1])
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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