ID

41048

Description

This form documents if any measurements were repeated during the study, if concomitant medications were taken or if any adverse events or ECG abnormalities occurred. To be assessed at study conclusion. 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)
  1. 6/16/20 6/16/20 -
  2. 9/17/21 9/17/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 16, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629

English

Logs and Repeats

1 forms  
  1. StudyEvent: ODM
    1. Logs and Repeats
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
1. Date of visit/assessment
Description

Date below is the start of the study for this subject

Data type

date

Alias
UMLS CUI [1]
C1320303
Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
Description

Adverse Event/Concomitant Medication/Repeat Assessment Check Questions

Alias
UMLS CUI-1
C0877248
UMLS CUI-3
C2347852
UMLS CUI-5
C0220825
2. Were any concomitant medications taken by the subject during the study?
Description

Concomitant Agent During Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
3. Did the subject experience any non-serious adverse events during the study?
Description

Non-serious Adverse Event During Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
4. Did the subject experience any serious adverse events during the study?
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
5. Were any repeat haematology or clinical chemistry samples taken?
Description

Hematology finding or Clinical Chemistry Sampling Repeat During Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0205341
UMLS CUI [1,4]
C0347984
UMLS CUI [1,5]
C0008976
UMLS CUI [2,1]
C0008000
UMLS CUI [2,2]
C0870078
UMLS CUI [2,3]
C0205341
UMLS CUI [2,4]
C0347984
UMLS CUI [2,5]
C0008976
6. Were any repeat urinalysis samples taken?
Description

Urinalysis, Sampling, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0205341
7. Were any repeat ECGs perfonned?
Description

Electrocardiography, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0205341
8. Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Description

ECG abnormality, Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C1832603
UMLS CUI [1,2]
C2826293
9. Were any repeat vital signs recorded?
Description

Vital signs, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
10. Were any repeat PK blood samples taken?
Description

Pharmacokinetic aspects Sampling Repeat During Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0205341
UMLS CUI [1,4]
C0347984
UMLS CUI [1,5]
C0008976
11. Were any repeat telemetry results taken?
Description

Telemetry, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C0205341
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Similar models

Logs and Repeats

1 forms
  1. StudyEvent: ODM
    1. Logs and Repeats
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of Visit/Assessment
Item
1. Date of visit/assessment
date
C1320303 (UMLS CUI [1])
Item Group
Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-3)
C0220825 (UMLS CUI-5)
Concomitant Agent During Clinical Trial
Item
2. Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Non-serious Adverse Event During Clinical Trial
Item
3. Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Serious Adverse Event
Item
4. Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
Hematology finding or Clinical Chemistry Sampling Repeat During Clinical Trial
Item
5. Were any repeat haematology or clinical chemistry samples taken?
boolean
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,5])
C0008000 (UMLS CUI [2,1])
C0870078 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
C0347984 (UMLS CUI [2,4])
C0008976 (UMLS CUI [2,5])
Urinalysis, Sampling, Repeat
Item
6. Were any repeat urinalysis samples taken?
boolean
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Electrocardiography, Repeat
Item
7. Were any repeat ECGs perfonned?
boolean
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
ECG abnormality, Clinical Significance
Item
8. Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
boolean
C1832603 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Vital signs, Repeat
Item
9. Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Pharmacokinetic aspects Sampling Repeat During Clinical Trial
Item
10. Were any repeat PK blood samples taken?
boolean
C0031328 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,5])
Telemetry, Repeat
Item
11. Were any repeat telemetry results taken?
boolean
C0039451 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
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