ID
32956
Beschrijving
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
Link
https://clinicaltrials.gov/ct2/show/NCT00875784
Trefwoorden
Versies (2)
- 18-11-18 18-11-18 -
- 21-11-18 21-11-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
21 november 2018
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784
12-Lead ECG
- StudyEvent: ODM
Beschrijving
ECG Measurement
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Date and Time of ECG
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1264639
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
QTc Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
RR Interval
Datatype
integer
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
Similar models
12-Lead ECG
- StudyEvent: ODM
C1264639 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])