ID

41050

Description

This form documents the telemetry procedure. To be filled in after telemetry is evaluated. 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 (1)
  1. 16/06/2020 16/06/2020 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

16 juin 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 4.0
Modèle Commentaires :

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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629

Anglais

Telemetry

1 Formulaires  
  1. StudyEvent: ODM
    1. Telemetry
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/assessment
Description

Visit Date

Type de données

date

Alias
UMLS CUI [1]
C1320303
DOSING DATE AND TIME
Description

DOSING DATE AND TIME

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C1264639
1. Dosing date/time
Description

Dosing Date/Time

Type de données

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1264639
TELEMETRY
Description

TELEMETRY

Alias
UMLS CUI-1
C0039451
2. Start Date and Time of Telemetry
Description

Hr:Min (00:00-23:59)

Type de données

datetime

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C3897500
3. Stop Date and Time of Telemetry
Description

Hr.Min (00:00-23:59)

Type de données

datetime

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C3899266
4. Result of Telemetry
Description

Telemetry Result

Type de données

text

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C1274040
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Telemetry

1 Formulaires
  1. StudyEvent: ODM
    1. Telemetry
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])
Visit Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
Item Group
DOSING DATE AND TIME
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
Dosing Date/Time
Item
1. Dosing date/time
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item Group
TELEMETRY
C0039451 (UMLS CUI-1)
Telemetry Start Date/Time
Item
2. Start Date and Time of Telemetry
datetime
C0039451 (UMLS CUI [1,1])
C3897500 (UMLS CUI [1,2])
Telemetry Stop Date/Time
Item
3. Stop Date and Time of Telemetry
datetime
C0039451 (UMLS CUI [1,1])
C3899266 (UMLS CUI [1,2])
Item
4. Result of Telemetry
text
C0039451 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Telemetry Result
Code List
4. Result of Telemetry
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 (No result)
CL Item
Unable to evaluate (Unable to evaluate)
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