ID
33053
Beskrivning
This form contains a form to document the study conclusion and pregnancy information. To be assessed at the follow-up visit. 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
Versioner (2)
- 2018-11-25 2018-11-25 -
- 2018-11-25 2018-11-25 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
25 november 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784
Study Conclusion and Pregnancy Information
- StudyEvent: ODM
Beskrivning
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Beskrivning
Date of subject completion or withdrawal
Datatyp
date
Alias
- UMLS CUI [1]
- C2983670
Beskrivning
If yes, complete primary reason for witltdrawal
Datatyp
text
Alias
- UMLS CUI [1]
- C0422727
Beskrivning
In case you tick Adverse Event: Record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. In case you tick Investigator discretion, specify in the next item. Select this reason if none of the other primary reasons are appropriate.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
Beskrivning
Withdrawal from the study at the investigator's discretion, specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1710220
- UMLS CUI [1,3]
- C0679006
- UMLS CUI [1,4]
- C2348235
Beskrivning
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beskrivning
if Yes, complete the paper Pregnancy Notification form Check Not Applicable iffemale partner not of childbearing potential or no female partner
Datatyp
text
Alias
- UMLS CUI [1]
- C0919624
Beskrivning
If Yes, complete the paper Pregnancy Notification form
Datatyp
text
Alias
- UMLS CUI [1]
- C0032961
Similar models
Study Conclusion and Pregnancy Information
- StudyEvent: ODM
C0392360 (UMLS CUI [1,2])
C1710220 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])