ID

33055

Beskrivning

This form contains a form to document the date of visit, liver events, investigational product (liver) and the pharmacokinetics. To be assessed at liver event visit. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders

Länk

https://clinicaltrials.gov/ct2/show/NCT00875784

Nyckelord

Versioner (1)
  1. 2018-11-25 2018-11-25 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

25 november 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629

Engelsk

Liver Event: Date of Visit, Liver Events, Investigational Product (Liver) and Pharmacokinetics

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date of visit/assessment
Beskrivning

Date of Visit/Assessment

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Liver Events Assessment
Beskrivning

Liver Events Assessment

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Beskrivning

(If no liver event, tick 'No' and enter date of study conclusion/withdrawal above) If Yes, stop investigational 1> roduct, complete date stopped on Investigational Product form, contact GSK within 24 hours of occurrence, complete Liver Events Form and obtain the following tests: * PK blood sample within 24 hours of last dose (or 3x the investigational product half life or tl/2: protocol specified longer value to be inserted). * Hepatitis A: Hepatitis A IgM antibody. * Hepatitis B: Hepatitis B surface antigen ,md Hepatitis B Core Antibody (IgM). * Hepatitis C: Hepatitis C RNA. * Hepatitis E lgM ,mtibody (if subjed resides or has trnvelled in the past 3 months outside the USA or Canadll). * Cytomegalovirus lgM antibody (CMV). * EBY (Epstein Barr virn1 capsid antigen IgM antibody) or if unavailable, obtain heterophile antibody or monospot testing.) * Bilirubin frnctionation, if bilirubin >= l.5xULN * CPK (serum creatine phosphokinase), * LDH (lactate dehydrogenase). The following are only needed when ALT >=3xULN and bilirubin >=t.SxULN (>35% direct) * Anti-nuclear antibody * Anti-smooth muscle antibody * Type I anti-liver kidney microsomal antibodies (if available) * Liver Imaging (ultrnsound, magnetic resonance, or computerised tomography) lf Yes, complete the Liver Event fonns displayed upon submission of this form Record the details of any Adverse Events or exacerbations of Adverse Events on the Non-Serious Adverse Event Form or the Serious Adverse Event form, Exacerbations of Adverse Events include increases in frequency and severity. It is particularly important to record any significant hypotension immediately prior to or concomitant with ALT elevation. It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023901
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C2133636
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? ALT (alanine aminotransferase)
Beskrivning

Did ALT reach or exceed the investigational product stopping criteria?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1521733
UMLS CUI [1,3]
C2133636
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? AST (aspartate aminotransferase)
Beskrivning

Did AST reach or exceed the investigational product stopping criteria?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1521733
UMLS CUI [1,3]
C2133636
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Total bilirubin
Beskrivning

Did the total bilirubin reach or exceed the investigational product stopping criteria?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C1521733
UMLS CUI [1,3]
C2133636
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Alkaline phosphatase
Beskrivning

Did the alkaline phosphatase reach or exceed the investigational product stopping criteria?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C1521733
UMLS CUI [1,3]
C2133636
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? 5' nucleotidase
Beskrivning

Did the 5' nucleotidase reach or exceed the investigational product stopping criteria?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0740292
UMLS CUI [1,2]
C1521733
UMLS CUI [1,3]
C2133636
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Gammaglutamyltranspeptidase
Beskrivning

Did the gammaglutamyltranspeptidase reach or exceed the investigational product stopping criteria?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0541979
UMLS CUI [1,2]
C1521733
UMLS CUI [1,3]
C2133636
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Other
Beskrivning

Did another liver chemistry result reach or exceed the investigational product stopping criteria?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C1521733
UMLS CUI [1,6]
C2133636
Is the subject age 55 or older?
Beskrivning

Subject age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
If female, is the subject pregnant?
Beskrivning

If yes, ensure Pregnancy Notification Fonn has been completed.

Datatyp

text

Alias
UMLS CUI [1]
C0032961
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
Beskrivning

Performance of any diagnostic imaging tests of the liver or hepatobiliary syste (such as ultrasound, CAT scan, MRI, endoscopic retrograde cholangiopancreatography)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1711359
UMLS CUI [1,3]
C0023884
UMLS CUI [2,1]
C1456803
UMLS CUI [2,2]
C0023884
UMLS CUI [3]
C0412620
UMLS CUI [4]
C0024485
UMLS CUI [5]
C0008310
If 'Yes' was ticked, were the results normal?
Beskrivning

If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Events form.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1711359
UMLS CUI [1,3]
C0023884
UMLS CUI [1,4]
C1274040
Were any liver biopsies performed?
Beskrivning

If yes, complete Liver Biopsy form

Datatyp

boolean

Alias
UMLS CUI [1]
C0193388
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Beskrivning

If yes, record on the appropriate Concomitant Medication form

Datatyp

boolean

Alias
UMLS CUI [1]
C2240391
UMLS CUI [2]
C1148474
UMLS CUI [3]
C0002346
UMLS CUI [4]
C0242295
UMLS CUI [5]
C0281875
Did the subject fast or undergo significant dietary change in the past week?
Beskrivning

Recent fasting or significant dietary change

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3671772
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0015663
UMLS CUI [2,2]
C0332185
Investigational Product (Liver)
Beskrivning

Investigational Product (Liver)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0023884
Start Date Investigational Product
Beskrivning

If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.

Datatyp

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C0087111
UMLS CUI [1,5]
C1948053
UMLS CUI [1,6]
C0304229
UMLS CUI [1,7]
C0808070
Not applicable
Beskrivning

Start Date Investigational Product Not applicable (Liver event occured during treatment period)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1272460
End Date Investigational Product
Beskrivning

If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.

Datatyp

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C0087111
UMLS CUI [1,5]
C1948053
UMLS CUI [1,6]
C0304229
UMLS CUI [1,7]
C0806020
Not applicable
Beskrivning

End Date Investigational Product Not applicable (Liver event occured during treatment period)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1272460
Start Date Investigational Product
Beskrivning

If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.

Datatyp

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C0087111
UMLS CUI [1,5]
C0032756
UMLS CUI [1,6]
C1948053
UMLS CUI [1,7]
C0304229
UMLS CUI [1,8]
C0808070
Not applicable
Beskrivning

Start Date Investigational Product Not applicable (Liver event occured after treatment period)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1272460
End Date Investigational Product
Beskrivning

If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.

Datatyp

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C0087111
UMLS CUI [1,5]
C0032756
UMLS CUI [1,6]
C1948053
UMLS CUI [1,7]
C0304229
UMLS CUI [1,8]
C0806020
Not applicable
Beskrivning

End Date Investigational Product Not applicable (Liver event occured after treatment period)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1272460
Pharmacokinetics
Beskrivning

Pharmacokinetics

Alias
UMLS CUI-1
C0031327
Was a pharmacokinetic blood sample obtained?
Beskrivning

An unscheduled PK blood sample must be obtained within 24 hours of last dose (or 3x the investigational product half-life or t1/2; protocol specified longer value to be inserted). If yes, document date and time sample taken in the next item as well as the date and time of last investigational product dose prior to PK sample and the Sample Identifier/Sample Number.

Datatyp

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005834
If a pharmacokinetic blood sample was obtained, date and time sample taken
Beskrivning

Date and time pharmacokinetic blood sample taken

Datatyp

datetime

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0201734
UMLS CUI [1,3]
C1264639
If a pharmacokinetic blood sample was obtained, date and time of last investigational product dose prior to PK sample
Beskrivning

Date and time of last investigational product dose prior to PK sample

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C0946444
If a pharmacokinetic blood sample was obtained, Sample Identifier/Sample Number
Beskrivning

Sample Identifier/Sample Number if a pharmacokinetic blood sample was obtained

Datatyp

text

Alias
UMLS CUI [1]
C1299222
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Similar models

Liver Event: Date of Visit, Liver Events, Investigational Product (Liver) and Pharmacokinetics

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of Visit/Assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
Item Group
Liver Events Assessment
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Liver chemistry reached or exceeded investigational product stopping criteria
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0023901 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C2133636 (UMLS CUI [1,3])
Did ALT reach or exceed the investigational product stopping criteria?
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? ALT (alanine aminotransferase)
boolean
C0201836 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
C2133636 (UMLS CUI [1,3])
Did AST reach or exceed the investigational product stopping criteria?
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? AST (aspartate aminotransferase)
boolean
C0201899 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
C2133636 (UMLS CUI [1,3])
Did the total bilirubin reach or exceed the investigational product stopping criteria?
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Total bilirubin
boolean
C0201913 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
C2133636 (UMLS CUI [1,3])
Did the alkaline phosphatase reach or exceed the investigational product stopping criteria?
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Alkaline phosphatase
boolean
C0201850 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
C2133636 (UMLS CUI [1,3])
Did the 5' nucleotidase reach or exceed the investigational product stopping criteria?
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? 5' nucleotidase
boolean
C0740292 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
C2133636 (UMLS CUI [1,3])
Did the gammaglutamyltranspeptidase reach or exceed the investigational product stopping criteria?
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Gammaglutamyltranspeptidase
boolean
C0541979 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
C2133636 (UMLS CUI [1,3])
Did another liver chemistry result reach or exceed the investigational product stopping criteria?
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Other
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C1521733 (UMLS CUI [1,5])
C2133636 (UMLS CUI [1,6])
Subject age
Item
Is the subject age 55 or older?
boolean
C0001779 (UMLS CUI [1])
Item
If female, is the subject pregnant?
text
C0032961 (UMLS CUI [1])
Pregnancy of female subject
Code List
If female, is the subject pregnant?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not applicable (Not applicable)
Performance of any diagnostic imaging tests of the liver or hepatobiliary syste (such as ultrasound, CAT scan, MRI, endoscopic retrograde cholangiopancreatography)
Item
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1456803 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C0412620 (UMLS CUI [3])
C0024485 (UMLS CUI [4])
C0008310 (UMLS CUI [5])
Results of the diagnostic imaging tests of the liver or hepatobiliary system
Item
If 'Yes' was ticked, were the results normal?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Liver biopsies
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
Use of herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C2240391 (UMLS CUI [1])
C1148474 (UMLS CUI [2])
C0002346 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0281875 (UMLS CUI [5])
Recent fasting or significant dietary change
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C3671772 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0015663 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Item Group
Investigational Product (Liver)
C0304229 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Start date of investigational product if liver event occured during treatment period
Item
Start Date Investigational Product
date
C0877248 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C1948053 (UMLS CUI [1,5])
C0304229 (UMLS CUI [1,6])
C0808070 (UMLS CUI [1,7])
Start Date Investigational Product Not applicable (Liver event occured during treatment period)
Item
Not applicable
boolean
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
End date of investigational product if liver event occured during treatment period
Item
End Date Investigational Product
date
C0877248 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C1948053 (UMLS CUI [1,5])
C0304229 (UMLS CUI [1,6])
C0806020 (UMLS CUI [1,7])
End Date Investigational Product Not applicable (Liver event occured during treatment period)
Item
Not applicable
boolean
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
Start date of investigational product if the liver event occured after treatment period
Item
Start Date Investigational Product
date
C0877248 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0032756 (UMLS CUI [1,5])
C1948053 (UMLS CUI [1,6])
C0304229 (UMLS CUI [1,7])
C0808070 (UMLS CUI [1,8])
Start Date Investigational Product Not applicable (Liver event occured after treatment period)
Item
Not applicable
boolean
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
End date of investigational product if liver event occured after treatment period
Item
End Date Investigational Product
date
C0877248 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0032756 (UMLS CUI [1,5])
C1948053 (UMLS CUI [1,6])
C0304229 (UMLS CUI [1,7])
C0806020 (UMLS CUI [1,8])
End Date Investigational Product Not applicable (Liver event occured after treatment period)
Item
Not applicable
boolean
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
Item Group
Pharmacokinetics
C0031327 (UMLS CUI-1)
Item
Was a pharmacokinetic blood sample obtained?
text
C0031328 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Pharmacokinetic blood sample
Code List
Was a pharmacokinetic blood sample obtained?
CL Item
Yes (Yes)
CL Item
No (No)
Date and time pharmacokinetic blood sample taken
Item
If a pharmacokinetic blood sample was obtained, date and time sample taken
datetime
C1277698 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Date and time of last investigational product dose prior to PK sample
Item
If a pharmacokinetic blood sample was obtained, date and time of last investigational product dose prior to PK sample
datetime
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
Sample Identifier/Sample Number if a pharmacokinetic blood sample was obtained
Item
If a pharmacokinetic blood sample was obtained, Sample Identifier/Sample Number
text
C1299222 (UMLS CUI [1])
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