ID
33046
Descripción
This form contains a form to document the results of the 12-lead ecg. To be assessed at the visits V1-3. 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)
- 18/11/18 18/11/18 -
- 25/11/18 25/11/18 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
25 de noviembre de 2018
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784
12-Lead ECG
- StudyEvent: ODM
Descripción
Dosing Date and Time
Alias
- UMLS CUI-1
- C0178602
- UMLS CUI-2
- C1264639
Descripción
ECG findings
Alias
- UMLS CUI-1
- C1623258
Descripción
Time of ECG
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Descripción
Heart rate
Tipo de datos
integer
Unidades de medida
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Descripción
PR Interval
Tipo de datos
float
Unidades de medida
- msec
Alias
- UMLS CUI [1]
- C0429087
Descripción
QRS Duration
Tipo de datos
float
Unidades de medida
- msec
Alias
- UMLS CUI [1]
- C0429025
Descripción
Uncorrected QT Interval
Tipo de datos
float
Unidades de medida
- msec
Alias
- UMLS CUI [1,1]
- C1287082
- UMLS CUI [1,2]
- C4072785
Descripción
QTc Interval
Tipo de datos
float
Unidades de medida
- msec
Alias
- UMLS CUI [1]
- C0489625
Descripción
RR Interval
Tipo de datos
float
Unidades de medida
- msec
Alias
- UMLS CUI [1]
- C0489636
Descripción
Method of QTc Calculation
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Descripción
complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0438154
Descripción
Planned Relative Time
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0439564
Similar models
12-Lead ECG
- StudyEvent: ODM
C1264639 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
C4072785 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])