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

  1. 2018-11-18 2018-11-18 -
  2. 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

  1. StudyEvent: ODM
    1. 12-Lead ECG
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Beskrivning

Visit Type

Datatyp

text

Alias
UMLS CUI [1]
C3641100
ECG Measurement
Beskrivning

ECG Measurement

Alias
UMLS CUI-1
C0430456
Date and Time of ECG Hr:Min (00:00-23:59)
Beskrivning

Date and Time of ECG

Datatyp

datetime

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1264639
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Beskrivning

PR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Beskrivning

Uncorrected QT Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc Interval
Beskrivning

QTc Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489625
msec
RR Interval
Beskrivning

RR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489636
msec
Method of QTc Calculation
Beskrivning

Method of QTc Calculation

Datatyp

text

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
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

  1. StudyEvent: ODM
    1. 12-Lead ECG
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Visit Type
text
C3641100 (UMLS CUI [1])
Code List
Visit Type
CL Item
screening (screening)
CL Item
follow-up (follow-up)
CL Item
early withdrawal (early withdrawal)
CL Item
logs/repeats (logs/repeats)
Item Group
ECG Measurement
C0430456 (UMLS CUI-1)
Date and Time of ECG
Item
Date and Time of ECG Hr:Min (00:00-23:59)
datetime
C1623258 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
RR Interval
Item
RR Interval
integer
C0489636 (UMLS CUI [1])
Item
Method of QTc Calculation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Code List
Method of QTc Calculation
CL Item
Machine (Machine)
CL Item
Manual (Manual)
Item
Result of the ECG
text
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Normal (Normal)
CL Item
Abnormal - Not clinically significant (Abnormal - Not clinically significant)
CL Item
Abnormal - Clinically significant (Abnormal - Clinically significant)
CL Item
No result (not available) (No result (not available))

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