ID

37569

Beschrijving

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

Trefwoorden

Versies (1)
  1. 07-08-19 07-08-19 -
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GlaxoSmithKline

Geüploaded op

7 augustus 2019

DOI

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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

Engels

Follow-Up - Vital Signs; Electronically Transferred Lab Data; Study Conclusion; Pregnancy Information

1 Formulieren  
Date of visit/assessment
Beschrijving

Date of visit/assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Beschrijving

Date of visit/assessment

Datatype

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Vital Signs - Actual Time
Beschrijving

Vital Signs - Actual Time

Datatype

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure
Beschrijving

Systolic Blood Pressure

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Beschrijving

Diastolic Blood Pressure

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Subject position
Beschrijving

(Position must be consistent throughout the study)

Datatype

integer

Alias
UMLS CUI [1]
C1262869
Electronically Transferred Lab Data
Beschrijving

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
Haematology Date and time sample taken
Beschrijving

Haematology Date and time sample taken

Datatype

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Haematology sample not taken
Beschrijving

Haematology sample not taken

Datatype

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Clinical Chemistry Date and time sample taken
Beschrijving

Clinical Chemistry Date and time sample taken

Datatype

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Clinical Chemistry sample not taken
Beschrijving

Clinical Chemistry sample not taken

Datatype

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Clinical Chemistry same as the Haematology sample
Beschrijving

Clinical Chemistry same as the Haematology sample

Datatype

integer

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [2]
C0018941
Urinalysis Date and time sample taken
Beschrijving

Urinalysis Date and time sample taken

Datatype

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Urinalysis sample not taken.
Beschrijving

Urinalysis sample not taken.

Datatype

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Study Conclusion
Beschrijving

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of last contact
Beschrijving

Date of last contact

Datatype

date

Alias
UMLS CUI [1]
C0805839
Was the subject withdrawn from the study?
Beschrijving

Was the subject withdrawn from the study?

Datatype

boolean

Alias
UMLS CUI [1]
C0422727
If subject was withdrawn from study, record Date of decision to withdraw.
Beschrijving

Date of decision to withdraw

Datatype

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
If subject was withdrawn from study, record primary reason for withdrawal.
Beschrijving

Primary reason for withdrawal from study

Datatype

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1549995
Case book ready for signature
Beschrijving

Data owner should check the box when data cleaning is complete

Datatype

integer

Alias
UMLS CUI [1]
C1519316
Pregnancy Information
Beschrijving

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Beschrijving

ff Yes, complete the paper Pregnancy Notification form

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Follow-Up - Vital Signs; Electronically Transferred Lab Data; Study Conclusion; Pregnancy Information

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Date of visit/assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Vital Signs - Actual Time
Item
Vital Signs - Actual Time
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Item
Subject position
integer
C1262869 (UMLS CUI [1])
Subject position
Code List
Subject position
CL Item
Semi-supine (4)
CL Item
Sitting (2)
Item Group
Electronically Transferred Lab Data
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
Haematology Date and time sample taken
Item
Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Haematology sample not taken
integer
C0018941 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Haematology sample not taken
Code List
Haematology sample not taken
CL Item
Not done (1)
Clinical Chemistry Date and time sample taken
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Clinical Chemistry sample not taken
integer
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Clinical Chemistry sample not taken
Code List
Clinical Chemistry sample not taken
CL Item
Not done (1)
Item
Clinical Chemistry same as the Haematology sample
integer
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2])
Clinical Chemistry same as the Haematology sample
Code List
Clinical Chemistry same as the Haematology sample
CL Item
Same as the Haematology sample (1)
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Urinalysis sample not taken.
integer
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Urinalysis sample not taken.
Code List
Urinalysis sample not taken.
CL Item
Not done (1)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Date of decision to withdraw
Item
If subject was withdrawn from study, record Date of decision to withdraw.
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If subject was withdrawn from study, record primary reason for withdrawal.
integer
C0422727 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Primary reason for withdrawal from study
Code List
If subject was withdrawn from study, record primary reason for withdrawal.
CL Item
Adverse Event (Record details on the Non - Serious Adverse Events or Serious Adverse Events forms as appropriate.) (1)
CL Item
Protocol deviation (3)
CL Item
Study closed/terminated (5)
CL Item
Lost to Follow - up (6)
CL Item
Withdrew consent (8)
Item
Case book ready for signature
integer
C1519316 (UMLS CUI [1])
Case book ready for signature
Code List
Case book ready for signature
CL Item
Yes (1)
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Did the subject become pregnant during the study?
Item
Did the subject become pregnant during the study?
boolean
C0032961 (UMLS CUI [1])
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