ID
32956
Beskrivning
This form contains a form to document the results of the 12-lead ecg. To be assessed at screening, follow-up and where required early withdrawal visit. It is also a part of the logs/repeats documentation. 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)
- 2018-11-18 2018-11-18 -
- 2018-11-21 2018-11-21 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
21 november 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784
12-Lead ECG
- StudyEvent: ODM
Beskrivning
ECG Measurement
Alias
- UMLS CUI-1
- C0430456
Beskrivning
Date and Time of ECG
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1264639
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
PR Interval
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C0429087
Beskrivning
QRS Duration
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C0429025
Beskrivning
Uncorrected QT Interval
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C1287082
Beskrivning
QTc Interval
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C0489625
Beskrivning
RR Interval
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C0489636
Beskrivning
Method of QTc Calculation
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beskrivning
(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)
Datatyp
text
Alias
- UMLS CUI [1]
- C0438154
Similar models
12-Lead ECG
- StudyEvent: ODM
C1264639 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])