ID

33046

Description

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

Lien

https://clinicaltrials.gov/ct2/show/NCT00875784

Mots-clés

Versions (2)
  1. 18/11/2018 18/11/2018 -
  2. 25/11/2018 25/11/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

25 novembre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

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Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784

Anglais

12-Lead ECG

1 Formulaires  
  1. StudyEvent: ODM
    1. 12-Lead ECG
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

Date of Visit

Type de données

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Description

Visit Type

Type de données

text

Alias
UMLS CUI [1]
C3641100
Dosing Date and Time
Description

Dosing Date and Time

Alias
UMLS CUI-1
C0178602
UMLS CUI-2
C1264639
Dosing date/time
Description

Dosing date/time

Type de données

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
ECG findings
Description

ECG findings

Alias
UMLS CUI-1
C1623258
Time of ECG Hr:Min (00:00-23:59)
Description

Time of ECG

Type de données

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
Heart rate
Description

Heart rate

Type de données

integer

Unités de mesure
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Description

PR Interval

Type de données

float

Unités de mesure
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Description

QRS Duration

Type de données

float

Unités de mesure
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Description

Uncorrected QT Interval

Type de données

float

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C4072785
msec
QTc Interval
Description

QTc Interval

Type de données

float

Unités de mesure
  • msec
Alias
UMLS CUI [1]
C0489625
msec
RR Interval
Description

RR Interval

Type de données

float

Unités de mesure
  • msec
Alias
UMLS CUI [1]
C0489636
msec
Method of QTc Calculation
Description

Method of QTc Calculation

Type de données

text

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

Type de données

text

Alias
UMLS CUI [1]
C0438154
Planned Relative Time
Description

Planned Relative Time

Type de données

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
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Similar models

12-Lead ECG

1 Formulaires
  1. StudyEvent: ODM
    1. 12-Lead ECG
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item
Visit Type
text
C3641100 (UMLS CUI [1])
Visit Type
Code List
Visit Type
CL Item
V1 (V1)
CL Item
V2 (V2)
CL Item
V3 (V3)
Item Group
Dosing Date and Time
C0178602 (UMLS CUI-1)
C1264639 (UMLS CUI-2)
Dosing date/time
Item
Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
ECG findings
C1623258 (UMLS CUI-1)
Time of ECG
Item
Time of ECG Hr:Min (00:00-23:59)
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
QTc Interval
Item
QTc Interval
float
C0489625 (UMLS CUI [1])
RR Interval
Item
RR Interval
float
C0489636 (UMLS CUI [1])
Item
Method of QTc Calculation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method of QTc Calculation
Code List
Method of QTc Calculation
CL Item
Machine (Machine)
CL Item
Manual (Manual)
Item
Result of the ECG
text
C0438154 (UMLS CUI [1])
Result of the ECG
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))
Item
Planned Relative Time
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Timepoint of ECG
Code List
Planned Relative Time
CL Item
Pre-dose (Pre-dose)
CL Item
1 hour (1 hour)
CL Item
2.25 hours (2.25 hours)
CL Item
5.5 hours (5.5 hours)
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