ID
32956
Description
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
Keywords
Versions (2)
- 11/18/18 11/18/18 -
- 11/21/18 11/21/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
November 21, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784
12-Lead ECG
- StudyEvent: ODM
Description
ECG Measurement
Alias
- UMLS CUI-1
- C0430456
Description
Date and Time of ECG
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1264639
Description
Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
PR Interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Duration
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429025
Description
Uncorrected QT Interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C1287082
Description
QTc Interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0489625
Description
RR Interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0489636
Description
Method of QTc Calculation
Data type
text
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Description
(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)
Data type
text
Alias
- UMLS CUI [1]
- C0438154
Similar models
12-Lead ECG
- StudyEvent: ODM
C1264639 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])