ID
33055
Description
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
Link
https://clinicaltrials.gov/ct2/show/NCT00875784
Keywords
Versions (1)
- 11/25/18 11/25/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
November 25, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629
Liver Event: Date of Visit, Liver Events, Investigational Product (Liver) and Pharmacokinetics
Description
Liver Events Assessment
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0220825
Description
(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.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0023901
- UMLS CUI [1,2]
- C0587081
- UMLS CUI [1,3]
- C2133636
Description
Did ALT reach or exceed the investigational product stopping criteria?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C1521733
- UMLS CUI [1,3]
- C2133636
Description
Did AST reach or exceed the investigational product stopping criteria?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C1521733
- UMLS CUI [1,3]
- C2133636
Description
Did the total bilirubin reach or exceed the investigational product stopping criteria?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C1521733
- UMLS CUI [1,3]
- C2133636
Description
Did the alkaline phosphatase reach or exceed the investigational product stopping criteria?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C1521733
- UMLS CUI [1,3]
- C2133636
Description
Did the 5' nucleotidase reach or exceed the investigational product stopping criteria?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0740292
- UMLS CUI [1,2]
- C1521733
- UMLS CUI [1,3]
- C2133636
Description
Did the gammaglutamyltranspeptidase reach or exceed the investigational product stopping criteria?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0541979
- UMLS CUI [1,2]
- C1521733
- UMLS CUI [1,3]
- C2133636
Description
Did another liver chemistry result reach or exceed the investigational product stopping criteria?
Data type
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
Description
Subject age
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
If yes, ensure Pregnancy Notification Fonn has been completed.
Data type
text
Alias
- UMLS CUI [1]
- C0032961
Description
Performance of any diagnostic imaging tests of the liver or hepatobiliary syste (such as ultrasound, CAT scan, MRI, endoscopic retrograde cholangiopancreatography)
Data type
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
Description
If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Events form.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1711359
- UMLS CUI [1,3]
- C0023884
- UMLS CUI [1,4]
- C1274040
Description
If yes, complete Liver Biopsy form
Data type
boolean
Alias
- UMLS CUI [1]
- C0193388
Description
If yes, record on the appropriate Concomitant Medication form
Data type
boolean
Alias
- UMLS CUI [1]
- C2240391
- UMLS CUI [2]
- C1148474
- UMLS CUI [3]
- C0002346
- UMLS CUI [4]
- C0242295
- UMLS CUI [5]
- C0281875
Description
Recent fasting or significant dietary change
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3671772
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0015663
- UMLS CUI [2,2]
- C0332185
Description
Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Description
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Data type
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
Description
Start Date Investigational Product Not applicable (Liver event occured during treatment period)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1272460
Description
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Data type
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
Description
End Date Investigational Product Not applicable (Liver event occured during treatment period)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1272460
Description
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.
Data type
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
Description
Start Date Investigational Product Not applicable (Liver event occured after treatment period)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1272460
Description
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.
Data type
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
Description
End Date Investigational Product Not applicable (Liver event occured after treatment period)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1272460
Description
Pharmacokinetics
Alias
- UMLS CUI-1
- C0031327
Description
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.
Data type
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005834
Description
Date and time pharmacokinetic blood sample taken
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0201734
- UMLS CUI [1,3]
- C1264639
Description
Date and time of last investigational product dose prior to PK sample
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [1,3]
- C0946444
Description
Sample Identifier/Sample Number if a pharmacokinetic blood sample was obtained
Data type
text
Alias
- UMLS CUI [1]
- C1299222
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Liver Event: Date of Visit, Liver Events, Investigational Product (Liver) and Pharmacokinetics
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C2745955 (UMLS CUI [1,3])
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C0032756 (UMLS CUI [1,5])
C1948053 (UMLS CUI [1,6])
C0304229 (UMLS CUI [1,7])
C0808070 (UMLS CUI [1,8])
C0304229 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
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