ID
33046
Beschrijving
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
Trefwoorden
Versies (2)
- 18-11-18 18-11-18 -
- 25-11-18 25-11-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
25 november 2018
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784
12-Lead ECG
- StudyEvent: ODM
Beschrijving
Dosing Date and Time
Alias
- UMLS CUI-1
- C0178602
- UMLS CUI-2
- C1264639
Beschrijving
ECG findings
Alias
- UMLS CUI-1
- C1623258
Beschrijving
Time of ECG
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
PR Interval
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C1287082
- UMLS CUI [1,2]
- C4072785
Beschrijving
QTc Interval
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
RR Interval
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0489636
Beschrijving
Method of QTc Calculation
Datatype
text
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
Planned Relative Time
Datatype
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])