ID

38563

Beschreibung

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

Stichworte

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  2. 24.10.19 24.10.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

24. Oktober 2019

DOI

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Lizenz

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

Englisch

End of Study

1 Formulare  
  1. StudyEvent: ODM
    1. End of Study
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Site
Beschreibung

Study Site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschreibung

Patient name

Datentyp

text

Alias
UMLS CUI [1]
C1299487
Patient No
Beschreibung

Patients, Identification number

Datentyp

integer

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

Date of Visit/Assessment

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

Date of visit; Assessment Date

Datentyp

date

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

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Has subject withdrawn consent for PGx research?
Beschreibung

Pharmacogenetic Test, Informed Consent, Withdraw

Datentyp

boolean

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Yes, date informed consent withdrawn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

Pharmacogenetic Test, Informed Consent, Withdraw, Date in time

Datentyp

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?
Beschreibung

Pharmacogenetic Test, Blood specimen, Destruction, Request

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Status of Treatment Blind

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

Blinded Clinical Study, Subject Unblinding Event Record

Datentyp

boolean

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

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

Datentyp

date

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

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

Datentyp

text

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

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

Datentyp

text

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

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?
Beschreibung

Medical Devices, Incident

Datentyp

boolean

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

Pregnancy Information

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

Pregnancy, During, Clinical Trials

Datentyp

boolean

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

Study Conclusion

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

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

Datentyp

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?
Beschreibung

Patient withdrawn from trial

Datentyp

boolean

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

Patient withdrawn from trial, Reason and justification, Primary

Datentyp

text

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

Patient withdrawn from trial, Reason and justification, Primary

Datentyp

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
Beschreibung

Clinical study case, Investigator Signature

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1706256
UMLS CUI [1,2]
C2346576
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Ähnliche Modelle

End of Study

1 Formulare
  1. StudyEvent: ODM
    1. End of Study
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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