ID
41048
Descripción
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
Link
https://clinicaltrials.gov/ct2/show/NCT00875784
Palabras clave
Versiones (2)
- 16/6/20 16/6/20 -
- 17/9/21 17/9/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
16 de junio de 2020
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 4.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629
Logs and Repeats
- StudyEvent: ODM
Descripción
Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-3
- C2347852
- UMLS CUI-5
- C0220825
Descripción
Concomitant Agent During Clinical Trial
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Descripción
Non-serious Adverse Event During Clinical Trial
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Descripción
Serious Adverse Event
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1519255
Descripción
Hematology finding or Clinical Chemistry Sampling Repeat During Clinical Trial
Tipo de datos
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
Descripción
Urinalysis, Sampling, Repeat
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0205341
Descripción
Electrocardiography, Repeat
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Descripción
ECG abnormality, Clinical Significance
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1832603
- UMLS CUI [1,2]
- C2826293
Descripción
Vital signs, Repeat
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Descripción
Pharmacokinetic aspects Sampling Repeat During Clinical Trial
Tipo de datos
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
Descripción
Telemetry, Repeat
Tipo de datos
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])