ID

37608

Description

Study ID: 108504 Clinical Study ID: 108504 Study Title: An Open Label, Single Dose, Randomised, Parallel Group Pharmacokinetic Study to Evaluate a Combination Product Containing Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects Administered at Three Doses. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989625 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: This is a pharmacokinetic study (Treximet) Trade Name: Naproxen Sodium and Sumatriptan Study Indication: Migraine Disorders

Keywords

Versions (1)
  1. 8/11/19 8/11/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 11, 2019

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Creative Commons BY-NC 3.0
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Evaluation of Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects NCT00989625

English

Logs/ Repeats - Concomitant Medication; Electronically Transferred Lab Data; Vital Signs

1 forms  
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Sequence number
Description

Sequence number

Data type

integer

Alias
UMLS CUI [1]
C2348184
Drug Name
Description

(Trade Name preferred)

Data type

text

Alias
UMLS CUI [1]
C0013227
Modified reported term
Description

Modified reported term

Data type

text

Alias
UMLS CUI [1]
C2826819
GSK Drug synonym
Description

GSK Drug synonym

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0871468
GSK Drug Collection code
Description

GSK Drug Collection code

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C0805701
Failed coding
Description

Failed coding

Data type

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Concomitant Medication Unit Dose
Description

Concomitant Medication Unit Dose

Data type

text

Alias
UMLS CUI [1]
C2826646
Concomitant Medication Units
Description

Concomitant Medication Units

Data type

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439148
Concomitant Medication Frequency
Description

Concomitant Medication Frequency

Data type

integer

Alias
UMLS CUI [1]
C2826654
Concomitant Medication Route
Description

Concomitant Medication Route

Data type

integer

Alias
UMLS CUI [1]
C2826730
Reason for Medication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Medication Start Date and Time
Description

Medication Start Date and Time

Data type

datetime

Alias
UMLS CUI [1]
C2826734
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C1301880
Medication taken Prior to Study?
Description

Medication taken Prior to Study?

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Concomitant medication ongoing?
Description

Concomitant medication ongoing?

Data type

boolean

Alias
UMLS CUI [1]
C2826666
End date and time of concomitant medication
Description

End date and time of concomitant medication

Data type

datetime

Alias
UMLS CUI [1]
C2826744
UMLS CUI [2]
C1522314
Electronically Transferred Lab Data
Description

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
Laboratory Test Type
Description

Laboratory Test Type

Data type

text

Alias
UMLS CUI [1]
C0022885
Date and time sample taken
Description

Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0200345
UMLS CUI [2,2]
C0040223
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
Vital Signs - Actual date/time
Description

Vital Signs - Actual date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1264639
Vital Signs - Blood pressure
Description

Vital Signs - Blood pressure

Data type

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0005823
Vital Signs - Systolic blood pressure
Description

Vital Signs - Systolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0439565
UMLS CUI [1,2]
C0871470
mm[Hg]
Vital Signs - Diastolic blood pressure
Description

Vital Signs - Diastolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0439565
UMLS CUI [1,2]
C0428883
mm[Hg]
Vital Signs - Subject position
Description

Vital Signs - Subject position

Data type

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1262869
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Similar models

Logs/ Repeats - Concomitant Medication; Electronically Transferred Lab Data; Vital Signs

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Sequence number
Item
Sequence number
integer
C2348184 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
GSK Drug synonym
Item
GSK Drug synonym
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
GSK Drug Collection code
Item
GSK Drug Collection code
text
C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Concomitant Medication Unit Dose
Item
Concomitant Medication Unit Dose
text
C2826646 (UMLS CUI [1])
Item
Concomitant Medication Units
integer
C2347852 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Units
Code List
Concomitant Medication Units
CL Item
Actuation  (1)
CL Item
Ampoule  (2)
CL Item
Application  (3)
CL Item
Area under curve  (4)
CL Item
Bottle  (5)
CL Item
Capsule  (6)
CL Item
Cubic centimeter  (7)
CL Item
Cup  (8)
CL Item
Gamma per kilogram per minute (9)
CL Item
Gram  (10)
CL Item
Drops  (11)
CL Item
100 International units/ml (12)
CL Item
Inhalation  (13)
CL Item
International units (14)
CL Item
International units per kilogram (15)
CL Item
International units per kilogram per hour  (16)
CL Item
International units per millilitre  (17)
CL Item
Litre (18)
CL Item
Lozenge  (19)
CL Item
Litre per minute  (20)
CL Item
Minimum alveolar concentration  (21)
CL Item
Mega becquerels (MBq) MBQ  (22)
CL Item
Microgram (MCG) (23)
CL Item
Micrograms per hour  (24)
CL Item
Microgram/kilogram  (25)
CL Item
Microgram/kilogram per minute  (26)
CL Item
Micrograms per minute  (27)
CL Item
Micrograms per millitre  (28)
CL Item
Microlitre  (29)
CL Item
Milliequivalent  (30)
CL Item
Milliequivalent per 24  (31)
CL Item
Milligram  (32)
CL Item
Milligram per day  (33)
CL Item
Milligram per hour  (34)
CL Item
Milligram/kilogram  (35)
CL Item
Milligram/kilogram per hour  (36)
CL Item
Milligram/kilogram per minute  (37)
CL Item
Milligram/metre squared  (38)
CL Item
Milligram/millilitre  (39)
CL Item
Milligrams percent  (40)
CL Item
Million international units  (41)
CL Item
Millilitre  (42)
CL Item
Millilitre per hour  (43)
CL Item
Millilitre per minute  (44)
CL Item
Millimole  (45)
CL Item
Megaunits (million units)  (46)
CL Item
Nebule  (47)
CL Item
Ounce  (48)
CL Item
Patch  (49)
CL Item
Percent  (50)
CL Item
Puff  (51)
CL Item
Sachet  (52)
CL Item
Spray  (53)
CL Item
Suppository  (54)
CL Item
Tablet (55)
CL Item
Tablespoon  (56)
CL Item
Teaspoon  (57)
CL Item
Microgram (UG)  (58)
CL Item
Units per hour  (59)
CL Item
Units per kilogram per minute  (60)
CL Item
Units per minute  (61)
CL Item
Units  (62)
CL Item
Unknown  (63)
CL Item
Vial  (64)
Item
Concomitant Medication Frequency
integer
C2826654 (UMLS CUI [1])
Frequency
Code List
Concomitant Medication Frequency
CL Item
2 times per week  (1)
CL Item
3 times per week  (2)
CL Item
4 times per week  (3)
CL Item
5 times per day  (4)
CL Item
5 times per week  (5)
CL Item
AC  (6)
CL Item
BID  (7)
CL Item
Continuous infusion  (8)
CL Item
HS  (9)
CL Item
Once daily  (10)
CL Item
Once only (11)
CL Item
PC  (12)
CL Item
PRN  (13)
CL Item
Q12H  (14)
CL Item
Q2H  (15)
CL Item
Every 2 weeks  (16)
CL Item
Q3D  (17)
CL Item
Every 3 months  (18)
CL Item
Every 3 weeks  (19)
CL Item
Q4D  (20)
CL Item
Q4H  (21)
CL Item
Q6H  (22)
CL Item
Q8H  (23)
CL Item
QAM  (24)
CL Item
QH  (25)
CL Item
QID  (26)
CL Item
Once a month  (27)
CL Item
Every other day  (28)
CL Item
QPM  (29)
CL Item
Once a week  (30)
CL Item
TID  (31)
CL Item
Unknown (32)
Item
Concomitant Medication Route
integer
C2826730 (UMLS CUI [1])
Route
Code List
Concomitant Medication Route
CL Item
Epidural (1)
CL Item
Gastrostomy tube (2)
CL Item
Intra-arterial  (3)
CL Item
Intra-articular  (4)
CL Item
Intra-bursa (5)
CL Item
Intradermal  (6)
CL Item
Inhalation  (7)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intranasal (10)
CL Item
Injection (11)
CL Item
Intraocular (12)
CL Item
Intraosteal (13)
CL Item
Intraperitoneal (14)
CL Item
Intrathecal (15)
CL Item
Intrauterine (16)
CL Item
Intravenous (17)
CL Item
Nasogastric (18)
CL Item
Nasal (19)
CL Item
Right eye (20)
CL Item
Ophthalmic  (21)
CL Item
Left eye (22)
CL Item
Otic (23)
CL Item
Other (24)
CL Item
Both eyes (25)
CL Item
Oral (26)
CL Item
Rectal (27)
CL Item
Subcutaneous (28)
CL Item
Sublingual (29)
CL Item
Transdermal (30)
CL Item
Topical (31)
CL Item
Unknown (32)
CL Item
Vaginal (33)
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medication Start Date and Time
Item
Medication Start Date and Time
datetime
C2826734 (UMLS CUI [1])
C2347852 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Medication taken Prior to Study?
Item
Medication taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Concomitant medication ongoing?
Item
Concomitant medication ongoing?
boolean
C2826666 (UMLS CUI [1])
End date and time of concomitant medication
Item
End date and time of concomitant medication
datetime
C2826744 (UMLS CUI [1])
C1522314 (UMLS CUI [2])
Item Group
Electronically Transferred Lab Data
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
Item
Laboratory Test Type
text
C0022885 (UMLS CUI [1])
Laboratory Test Type
Code List
Laboratory Test Type
CL Item
Haematology (H)
CL Item
Clinical Chemistry (C)
CL Item
Urinalysis (U)
CL Item
AST/ALT (A)
Date and time sample taken
Item
Date and time sample taken
datetime
C0200345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Vital Signs - Actual date/time
Item
Vital Signs - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Vital Signs - Blood pressure
integer
C0518766 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])
Blood pressure
Code List
Vital Signs - Blood pressure
CL Item
Not done (1)
Vital Signs - Systolic blood pressure
Item
Vital Signs - Systolic blood pressure
integer
C0439565 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
Vital Signs - Diastolic blood pressure
Item
Vital Signs - Diastolic blood pressure
integer
C0439565 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
Item
Vital Signs - Subject position
integer
C0518766 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
Vital Signs - Subject position
Code List
Vital Signs - Subject position
CL Item
Semi-supine (4)
CL Item
Sitting (2)
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