ID
41048
Beskrivning
This form documents if any measurements were repeated during the study, if concomitant medications were taken or if any adverse events or ECG abnormalities occurred. To be assessed at study conclusion. 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 (2)
- 2020-06-16 2020-06-16 -
- 2021-09-17 2021-09-17 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
16 juni 2020
DOI
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Licens
Creative Commons BY-NC 4.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629
Logs and Repeats
- StudyEvent: ODM
Beskrivning
Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-3
- C2347852
- UMLS CUI-5
- C0220825
Beskrivning
Concomitant Agent During Clinical Trial
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Beskrivning
Non-serious Adverse Event During Clinical Trial
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Beskrivning
Serious Adverse Event
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Hematology finding or Clinical Chemistry Sampling Repeat During Clinical Trial
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0205341
- UMLS CUI [1,4]
- C0347984
- UMLS CUI [1,5]
- C0008976
- UMLS CUI [2,1]
- C0008000
- UMLS CUI [2,2]
- C0870078
- UMLS CUI [2,3]
- C0205341
- UMLS CUI [2,4]
- C0347984
- UMLS CUI [2,5]
- C0008976
Beskrivning
Urinalysis, Sampling, Repeat
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0205341
Beskrivning
Electrocardiography, Repeat
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Beskrivning
ECG abnormality, Clinical Significance
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1832603
- UMLS CUI [1,2]
- C2826293
Beskrivning
Vital signs, Repeat
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Beskrivning
Pharmacokinetic aspects Sampling Repeat During Clinical Trial
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0205341
- UMLS CUI [1,4]
- C0347984
- UMLS CUI [1,5]
- C0008976
Beskrivning
Telemetry, Repeat
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0039451
- UMLS CUI [1,2]
- C0205341
Similar models
Logs and Repeats
- StudyEvent: ODM
C2347852 (UMLS CUI-3)
C0220825 (UMLS CUI-5)
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,5])
C0008000 (UMLS CUI [2,1])
C0870078 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
C0347984 (UMLS CUI [2,4])
C0008976 (UMLS CUI [2,5])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,5])
C0205341 (UMLS CUI [1,2])