ID

38563

Descrição

Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Palavras-chave

Versões (2)
  1. 24/10/2019 24/10/2019 -
  2. 24/10/2019 24/10/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

24 de outubro de 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636

Inglês

End of Study

1 Formulários  
  1. StudyEvent: ODM
    1. End of Study
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Site
Descrição

Study Site

Tipo de dados

text

Alias
UMLS CUI [1]
C2825164
Patient
Descrição

Patient name

Tipo de dados

text

Alias
UMLS CUI [1]
C1299487
Patient No
Descrição

Patients, Identification number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Date of Visit/Assessment
Descrição

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Descrição

Date of visit; Assessment Date

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Pharmacogenetic (PGx) Research Withdrawal of Consent
Descrição

Pharmacogenetic (PGx) Research Withdrawal of Consent

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0021430
UMLS CUI-3
C2349954
Has subject withdrawn consent for PGx research?
Descrição

Pharmacogenetic Test, Informed Consent, Withdraw

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2349954
Yes, date informed consent withdrawn
Descrição

Pharmacogenetic Test, Informed Consent, Withdraw, Date in time

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2349954
UMLS CUI [1,4]
C0011008
Has a request been made for blood sample destruction?
Descrição

Pharmacogenetic Test, Blood specimen, Destruction, Request

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C1272683
Yes, check reason
Descrição

Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C1272683
UMLS CUI [1,5]
C0566251
Other, specify
Descrição

Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C1272683
UMLS CUI [1,5]
C0566251
Status of Treatment Blind
Descrição

Status of Treatment Blind

Alias
UMLS CUI-1
C2347038
UMLS CUI-2
C0449438
Was the treatment blind broken during the study?
Descrição

Blinded Clinical Study, Subject Unblinding Event Record

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2347038
UMLS CUI [1,2]
C3897431
Yes, Date blind broken
Descrição

Blinded Clinical Study, Subject Unblinding Event Record, Date in time

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2347038
UMLS CUI [1,2]
C3897431
UMLS CUI [1,3]
C0011008
Yes, Reason blind broken
Descrição

Blinded Clinical Study, Subject Unblinding Event Record, Reason and justification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2347038
UMLS CUI [1,2]
C3897431
UMLS CUI [1,3]
C0566251
Other, specify
Descrição

Blinded Clinical Study, Subject Unblinding Event Record, Reason and justification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2347038
UMLS CUI [1,2]
C3897431
UMLS CUI [1,3]
C0566251
Medical Device Question
Descrição

Medical Device Question

Alias
UMLS CUI-1
C0025080
UMLS CUI-2
C1522634
Did the subject experience an incident or near incident with GSK medical devices provided for use during this study?
Descrição

Medical Devices, Incident

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025080
UMLS CUI [1,2]
C1551358
Pregnancy Information
Descrição

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Descrição

Pregnancy, During, Clinical Trials

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Study Conclusion
Descrição

Study Conclusion

Alias
UMLS CUI-1
C0008976
UMLS CUI-2
C1707478
Date of subject completion or withdrawal
Descrição

Completion Status, Date in time; Withdraw, Date in time

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0805732
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C2349954
UMLS CUI [2,2]
C0011008
Was the subject withdrawn from the study?
Descrição

Patient withdrawn from trial

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0422727
Yes, Primary reason for withdrawal
Descrição

Patient withdrawn from trial, Reason and justification, Primary

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205225
Specify
Descrição

Patient withdrawn from trial, Reason and justification, Primary

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205225
For Data Managers or Monitors only: Tick or untick this box to require the investigator to re-sign the case book
Descrição

Clinical study case, Investigator Signature

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1706256
UMLS CUI [1,2]
C2346576
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Similar models

End of Study

1 Formulários
  1. StudyEvent: ODM
    1. End of Study
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient name
Item
Patient
text
C1299487 (UMLS CUI [1])
Patients, Identification number
Item
Patient No
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit; Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
Pharmacogenetic (PGx) Research Withdrawal of Consent
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
Pharmacogenetic Test, Informed Consent, Withdraw
Item
Has subject withdrawn consent for PGx research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Pharmacogenetic Test, Informed Consent, Withdraw, Date in time
Item
Yes, date informed consent withdrawn
date
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Pharmacogenetic Test, Blood specimen, Destruction, Request
Item
Has a request been made for blood sample destruction?
boolean
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
Item
Yes, check reason
text
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
Code List
Yes, check reason
CL Item
Subject withdrew consent for PGx  (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
Item
Other, specify
text
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
Item Group
Status of Treatment Blind
C2347038 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Blinded Clinical Study, Subject Unblinding Event Record
Item
Was the treatment blind broken during the study?
boolean
C2347038 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Blinded Clinical Study, Subject Unblinding Event Record, Date in time
Item
Yes, Date blind broken
date
C2347038 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Yes, Reason blind broken
text
C2347038 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Blinded Clinical Study, Subject Unblinding Event Record, Reason and justification
Code List
Yes, Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (2)
Blinded Clinical Study, Subject Unblinding Event Record, Reason and justification
Item
Other, specify
text
C2347038 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item Group
Medical Device Question
C0025080 (UMLS CUI-1)
C1522634 (UMLS CUI-2)
Medical Devices, Incident
Item
Did the subject experience an incident or near incident with GSK medical devices provided for use during this study?
boolean
C0025080 (UMLS CUI [1,1])
C1551358 (UMLS CUI [1,2])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Pregnancy, During, Clinical Trials
Item
Did the subject become pregnant during the study?
boolean
C0032961 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item Group
Study Conclusion
C0008976 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
Completion Status, Date in time; Withdraw, Date in time
Item
Date of subject completion or withdrawal
date
C0805732 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C2349954 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Patient withdrawn from trial
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Yes, Primary reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Patient withdrawn from trial, Reason and justification, Primary
Code List
Yes, Primary reason for withdrawal
CL Item
Adverse Event - No subreasons (1)
CL Item
Adverse Event - Subject met the GSK defined Liver Chemistry Stopping Criteria (2)
CL Item
Lack of efficacy  (3)
CL Item
Protocol deviation - No subreasons (4)
CL Item
Protocol deviation - Subject failed to provide T-SMBP measurements for 2 migraine attacks per month  (5)
CL Item
Protocol deviation - Prohibited medication use (6)
CL Item
Protocol deviation - New information about subject's history violates inclusion/exclusion criteria (7)
CL Item
Protocol deviation - New information about subject's meds violates inclusion/exclusion criteria  (8)
CL Item
Protocol deviation - Glycosylated hemoglobin >=8.0 (9)
CL Item
Subject reached protocol defined stopping criteria - No subreasons (9)
CL Item
Subject reached protocol defined stopping criteria - Monthly avg BP >= 140/90 mmHg on T-SMBP confirmed by rpt measurement in clinic (10)
CL Item
Subject reached protocol defined stopping criteria - Monthly avg incr >= 30 mmHg Sys or >= 20 mmHg Dia from in-clinic screening BP on T-SMBP confirmed in clinic (11)
CL Item
Subject reached protocol defined stopping criteria - Sys BP >=140 mmHg or Dia BP >= 90 mm Hg on consecutive visits at least 2wks apart (12)
CL Item
Subject reached protocol defined stopping criteria - Pregnancy (13)
CL Item
Subject reached protocol defined stopping criteria - Insufficient attacks(After first 3 months of treatment period, subject has treated on average <2 migraine attacks/month)  (14)
CL Item
Study closed/terminated (15)
CL Item
Lost to follow-up (15)
CL Item
Investigator discretion, specify  (16)
CL Item
Withdrew consent, Specify (17)
Patient withdrawn from trial, Reason and justification, Primary
Item
Specify
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Clinical study case, Investigator Signature
Item
For Data Managers or Monitors only: Tick or untick this box to require the investigator to re-sign the case book
boolean
C1706256 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
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