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37361

Beschreibung

Study ID: 111592 Clinical Study ID: 111592 Study Title: A Randomized, Double-blind, Placebo-controlled, Doseescalation Study to Assess the Anti-inflammatory Activity, Efficacy, and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury or ARDS Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996840 See https://clinicaltrials.gov/ct2/show/NCT00996840 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, SB-681323 Trade Name: N/A Study Indication: Lung Injury, Acute The primary objective of this phase 2 trial is to evaluate the safety and tolerability of intravenous dilmapimod/SB-681323 given in escalating dosages and over different intervals for three days in trauma patients at risk for the development of ALI or ARDS. This study consists of Screening, infusion of dilmapimod/SB-681323 on days 1-3, examination/sampling up to early day 5 (denoted as "Day 3 - 48 hrs") and a Follow-up on day 7. There are four cohorts, cohorts 1 and 3 receive the medication (or placebo) infusion over 4 hours, cohorts 2 and 4 over 24 hours. This form contains the Study Conclusion, information on the treatment blind and whether a pregnancy has occured during the study, as well as the Investigator's Signature. This form is to be completed at Follow-up or if the participant has/was withdrawn from the trial.

Link

https://clinicaltrials.gov/ct2/show/NCT00996840

Stichworte

Versionen (1)
  1. 20.07.19 20.07.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. Juli 2019

DOI

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Creative Commons BY-NC 3.0
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    SB-681323 in ALI/ARDS risk patients - NCT00996840

    Englisch

    Study Conclusion

    1 Formulare  
    1. StudyEvent: ODM
      1. Study Conclusion
    Administrative Data
    Beschreibung

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Beschreibung

    Subject Number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date/Time of Assessment
    Beschreibung

    Date/Time of Assessment

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C1516048
    UMLS CUI [1,2]
    C1264639
    Cohort
    Beschreibung

    Cohort

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0599755
    Study Conclusion
    Beschreibung

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008976
    Date of last contact
    Beschreibung

    Date last contact

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0805839
    Was the subject withdrawn from the study?
    Beschreibung

    If no: Date of last contact must match the last scheduled study visit date. If yes: complete details. Date of decision to withdraw must match the date of decision to withdraw the subject from the study before normal completion. Date of last contact must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. Note: An ’actual contact’ is defined as an interaction between the subject and the investigator or investigator’s designee, where the investigator/designee has the opportunity to query the subject about the subject’s status. This would include clinic visits and telephone contacts, but normally would not include mail correspondence or third party reports.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    Date of decision to withdraw
    Beschreibung

    if applicable

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0679006
    UMLS CUI [1,3]
    C0011008
    Primary reason for withdrawal
    Beschreibung

    if 1 = Adverse Event, please record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. if 7 = Investigator discretion, specify in next question. Select this reason if none of the other primary reasons are appropriate.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C1549995
    Investigator discretion, specify
    Beschreibung

    if applicable

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2348235
    UMLS CUI [1,2]
    C0008961
    UMLS CUI [1,3]
    C0022423
    Case book ready for signature [hidden]
    Beschreibung

    Data owner should check the box when data cleaning is complete

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1706256
    UMLS CUI [1,2]
    C1519316
    Office Use 1 [hidden]
    Beschreibung

    Office Use 1 [hidden]

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0442603
    Office Use 2 [hidden]
    Beschreibung

    Office Use 2 [hidden]

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0442603
    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

    If yes, complete the Adverse Event form and/or Investigational Product forms as appropriate, and additional questions in this form.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3897431
    Date/time blind broken
    Beschreibung

    if applicable

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C1264639
    Reason blind broken
    Beschreibung

    if applicable If other, please specify

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0566251
    Specification of reason treatment blind broken
    Beschreibung

    if applicable

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0566251
    UMLS CUI [1,2]
    C3897431
    UMLS CUI [1,3]
    C2348235
    Pregnancy Information (female)
    Beschreibung

    Pregnancy Information (female)

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

    If Yes, complete the paper Pregnancy Notification form

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3828490
    Pregnancy Information (male)
    Beschreibung

    Pregnancy Information (male)

    Alias
    UMLS CUI-1
    C0032961
    UMLS CUI-2
    C1533716
    Did a female partner of the male subject become pregnant during the study?
    Beschreibung

    If Yes, complete the paper Pregnancy Notification form Check "Not Applicable" if female partner not of childbearing potential or no female partner.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0919624
    UMLS CUI [1,2]
    C0439659
    UMLS CUI [1,3]
    C0347984
    UMLS CUI [1,4]
    C0008976
    Electronic Signature
    Beschreibung

    Electronic Signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator first and last Name
    Beschreibung

    By my dated signature below, I [investigator first and last name] verify that all case report form pages accurately display the results of the examinations, tests, evaluations and treatments performed on this patient.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2826892
    Date of electronic signature
    Beschreibung

    Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Study Conclusion

    1 Formulare
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Date/Time of Assessment
    Item
    Date/Time of Assessment
    datetime
    C1516048 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    Item
    Cohort
    integer
    C0599755 (UMLS CUI [1])
    Cohort
    Code List
    Cohort
    CL Item
    Cohort 1 (1)
    CL Item
    Cohort 2 (2)
    CL Item
    Cohort 3 (3)
    CL Item
    Cohort 4 (4)
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    Date last contact
    Item
    Date of last contact
    date
    C0805839 (UMLS CUI [1])
    Subject withdrawn
    Item
    Was the subject withdrawn from the study?
    boolean
    C0422727 (UMLS CUI [1])
    Withdrawal decision date
    Item
    Date of decision to withdraw
    date
    C0422727 (UMLS CUI [1,1])
    C0679006 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Primary reason for withdrawal
    integer
    C0422727 (UMLS CUI [1,1])
    C1549995 (UMLS CUI [1,2])
    primary withdrawal reason
    Code List
    Primary reason for withdrawal
    CL Item
    Adverse Event (1)
    CL Item
    Lack of efficacy (2)
    CL Item
    Protocol deviation (3)
    CL Item
    Subject reached protocol defined stopping criteria (4)
    CL Item
    Study closed/terminated (5)
    CL Item
    Lost to Follow-up (6)
    CL Item
    Investigator discretion (7)
    CL Item
    Withdrew consent (8)
    Specification investigator discretion
    Item
    Investigator discretion, specify
    text
    C2348235 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    C0022423 (UMLS CUI [1,3])
    Case book ready for signature [hidden]
    Item
    Case book ready for signature [hidden]
    boolean
    C1706256 (UMLS CUI [1,1])
    C1519316 (UMLS CUI [1,2])
    Office Use 1 [hidden]
    Item
    Office Use 1 [hidden]
    boolean
    C0442603 (UMLS CUI [1])
    Office Use 2 [hidden]
    Item
    Office Use 2 [hidden]
    integer
    C0442603 (UMLS CUI [1])
    Item Group
    Status of Treatment Blind
    C2347038 (UMLS CUI-1)
    C0449438 (UMLS CUI-2)
    Treatment blind broken
    Item
    Was the treatment blind broken during the study?
    boolean
    C3897431 (UMLS CUI [1])
    Date/time blind broken
    Item
    Date/time blind broken
    datetime
    C3897431 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    Item
    Reason blind broken
    integer
    C3897431 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    Reason blind broken
    Code List
    Reason blind broken
    CL Item
    Medical emergency requiring identification of investigational product for further treatment (1)
    CL Item
    Other (2)
    Specification of reason treatment blind broken
    Item
    Specification of reason treatment blind broken
    text
    C0566251 (UMLS CUI [1,1])
    C3897431 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item Group
    Pregnancy Information (female)
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    subject became pregnant during study
    Item
    Did the subject become pregnant during the study?
    boolean
    C3828490 (UMLS CUI [1])
    Item Group
    Pregnancy Information (male)
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Item
    Did a female partner of the male subject become pregnant during the study?
    text
    C0919624 (UMLS CUI [1,1])
    C0439659 (UMLS CUI [1,2])
    C0347984 (UMLS CUI [1,3])
    C0008976 (UMLS CUI [1,4])
    partner became pregnant during study
    Code List
    Did a female partner of the male subject become pregnant during the study?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    CL Item
    Not Applicable (X)
    Item Group
    Electronic Signature
    C2346576 (UMLS CUI-1)
    Investigator Name
    Item
    Investigator first and last Name
    text
    C2826892 (UMLS CUI [1])
    Date of electronic signature
    Item
    Date of electronic signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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