ID

35620

Beschreibung

Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis

Stichworte

Versionen (2)
  1. 12.03.19 12.03.19 -
  2. 30.10.19 30.10.19 - Sarah Riepenhausen
Rechteinhaber

GSK group of companies

Hochgeladen am

12. März 2019

DOI

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Creative Commons BY-NC 3.0
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The effect of intranasal capsaicin challenge model in healthy volunteers - 111611

Englisch

Repeating Logs

1 Formulare  
  1. StudyEvent: ODM
    1. Repeating Logs
Administrative data
Beschreibung

Administrative data

Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Adverse Event/Concomitant Medications/Repeat Assessment (Check Questions)
Beschreibung

Adverse Event/Concomitant Medications/Repeat Assessment (Check Questions)

Were any concomitant medications taken by the subject during the study?
Beschreibung

Concomitant Medication

Datentyp

boolean

Did the subject experience any non-serious adverse events during the study?
Beschreibung

Non-Serious Adverse Events

Datentyp

boolean

Did the subject experience any serious adverse events during the study?
Beschreibung

Serious Adverse Events

Datentyp

boolean

Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Beschreibung

Clinically Significant ECG Measurements

Datentyp

boolean

Were any repeat hematology or clinical chemistry samples taken?
Beschreibung

Repeat Hematology/ Clinical Chemistry

Datentyp

boolean

Were any repeat ECGs performed?
Beschreibung

Repeat ECGs

Datentyp

boolean

Were any repeat vital signs or temperature measurements recorded?
Beschreibung

Repeat Vital Signs / Temperature

Datentyp

boolean

Were any repeat PK blood samples taken?
Beschreibung

Repeat PK Blood Samples

Datentyp

boolean

Were any repeat Peak Nasal Inspiratory Flow tests performed?
Beschreibung

Repeat Peak Nasal Inspiratory Flow Tests

Datentyp

boolean

NON-SERIOUS ADVERSE EVENTS
Beschreibung

NON-SERIOUS ADVERSE EVENTS

Event Number
Beschreibung

Event Number

Datentyp

integer

Event Description
Beschreibung

Diagnosis or Signs/Symptoms

Datentyp

text

Start Date and Time
Beschreibung

Start Date and Time

Datentyp

datetime

End Date and Time
Beschreibung

End Date and Time

Datentyp

datetime

Outcome
Beschreibung

Outcome

Datentyp

text

Frequency
Beschreibung

Frequency

Datentyp

text

Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

text

Action Taken with Investigational Product(s) as a result of the AE?
Beschreibung

Action Taken

Datentyp

text

Did the subject withdraw from study as a result of this AE?
Beschreibung

Subject Withdrawal

Datentyp

boolean

Is there a reasonable possibility tha the AE may have been caused by the investigational product?
Beschreibung

Causality

Datentyp

boolean

SERIOUS ADVERSE EVENTS
Beschreibung

SERIOUS ADVERSE EVENTS

SAE Number
Beschreibung

SAE Number

Datentyp

integer

Serious Adverse Event Description
Beschreibung

Diagnosis or Sighs/Symptoms

Datentyp

text

Start Date and Time
Beschreibung

Start Date and Time

Datentyp

datetime

End Date and Time
Beschreibung

End Date and Time

Datentyp

datetime

Outcome
Beschreibung

Outcome

Datentyp

text

Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

text

Action Taken with Investigational Product(s) as a Result of the SAE
Beschreibung

Action Taken

Datentyp

text

Did the subject withdraw from the study as a result of this SAE?
Beschreibung

Subject Withdrawn

Datentyp

boolean

Is there a reasonable possibility tha the AE may have been caused by the investigational product?
Beschreibung

Causality

Datentyp

boolean

Was SAE cause by activities related to study participation(e.g. procedures)?
Beschreibung

Was SAE study related?

Datentyp

boolean

Was the event serious
Beschreibung

Seriousness of Event

Datentyp

boolean

How serious was the SAE?
Beschreibung

SAE Seriousness Level

Datentyp

text

If Other, please specify
Beschreibung

Specify Other

Datentyp

text

Did SAE occur after initiation of study medication?
Beschreibung

SAE Occurrence after study initiation

Datentyp

boolean

Type of Report
Beschreibung

Type of Report

Datentyp

text

RELEVANT CONCOMITANT/TREATMENT MEDICATIONS
Beschreibung

RELEVANT CONCOMITANT/TREATMENT MEDICATIONS

Drug/Medication sequence number
Beschreibung

Drug/Medication sequence number

Datentyp

integer

Drug Name
Beschreibung

Trade name preferred

Datentyp

text

Dose
Beschreibung

Dose

Datentyp

text

Unit
Beschreibung

Unit

Datentyp

text

Frequency
Beschreibung

Frequency

Datentyp

text

Route
Beschreibung

Route

Datentyp

text

Start Date
Beschreibung

Start Date

Datentyp

date

Ongoing?
Beschreibung

Ongoing?

Datentyp

boolean

Reason for Medication
Beschreibung

Primary Indication

Datentyp

text

Was the medication taken prior to Study?
Beschreibung

Taken prior to Study

Datentyp

boolean

RELEVANT MEDICAL CONDITION/RISK FACTORS
Beschreibung

RELEVANT MEDICAL CONDITION/RISK FACTORS

Condition number
Beschreibung

Condition number

Datentyp

integer

Specific Condition Name
Beschreibung

Specific Condition Name

Datentyp

text

Date of onset
Beschreibung

Start Date

Datentyp

date

Ongoing?
Beschreibung

Ongoing?

Datentyp

text

Date of last occurrence
Beschreibung

End Date

Datentyp

date

Relevant Medical History / Risk Factors not noted above
Beschreibung

Medical History

Datentyp

text

12-lead/Holter/Telemetry ECG
Beschreibung

12-lead/Holter/Telemetry ECG

Date and Time of ECG
Beschreibung

Date and Time of ECG

Datentyp

datetime

Heart Rate
Beschreibung

Heart Rate

Datentyp

integer

Maßeinheiten
  • bpm
bpm
PR Interval
Beschreibung

PR Interval

Datentyp

float

Maßeinheiten
  • msec
msec
QRS Duration
Beschreibung

QRS Duration

Datentyp

float

Maßeinheiten
  • msec
msec
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

float

Maßeinheiten
  • msec
msec
QTc Interval
Beschreibung

QTc Interval

Datentyp

float

Maßeinheiten
  • msec
msec
Method of QTc Canculation
Beschreibung

Method of QTc Canculation

Datentyp

text

Result of the ECG
Beschreibung

Result of the ECG

Datentyp

text

CONCOMITANT MEDICATION
Beschreibung

CONCOMITANT MEDICATION

Drug/Medication sequence number
Beschreibung

Drug/Medication sequence number

Datentyp

integer

Drug Name
Beschreibung

Trade Name preferred

Datentyp

text

Dose
Beschreibung

Dose

Datentyp

text

Unit
Beschreibung

Unit

Datentyp

text

Frequency
Beschreibung

Frequency

Datentyp

text

Route
Beschreibung

Route

Datentyp

text

Start Date
Beschreibung

Start Date

Datentyp

date

End Date
Beschreibung

End Date

Datentyp

date

Ongoing?
Beschreibung

Ongoing?

Datentyp

boolean

Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

Taken Prior to Study?
Beschreibung

Taken Prior to Study?

Datentyp

boolean

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Ähnliche Modelle

Repeating Logs

1 Formulare
  1. StudyEvent: ODM
    1. Repeating Logs
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
Date of Visit
Item
Date of Visit
date
Item Group
Adverse Event/Concomitant Medications/Repeat Assessment (Check Questions)
Concomitant Medication
Item
Were any concomitant medications taken by the subject during the study?
boolean
Non-Serious Adverse Events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
Serious Adverse Events
Item
Did the subject experience any serious adverse events during the study?
boolean
Clinically Significant ECG Measurements
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
boolean
Repeat Hematology/ Clinical Chemistry
Item
Were any repeat hematology or clinical chemistry samples taken?
boolean
Repeat ECGs
Item
Were any repeat ECGs performed?
boolean
Repeat Vital Signs / Temperature
Item
Were any repeat vital signs or temperature measurements recorded?
boolean
Repeat PK Blood Samples
Item
Were any repeat PK blood samples taken?
boolean
Repeat Peak Nasal Inspiratory Flow Tests
Item
Were any repeat Peak Nasal Inspiratory Flow tests performed?
boolean
Item Group
NON-SERIOUS ADVERSE EVENTS
Event Number
Item
Event Number
integer
Event Description
Item
Event Description
text
Start Date and Time
Item
Start Date and Time
datetime
End Date and Time
Item
End Date and Time
datetime
Item
Outcome
text
Outcome
Code List
Outcome
CL Item
Recovered/Resolved  (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
Item
Frequency
text
Frequency
Code List
Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a result of the AE?
text
Action Taken
Code List
Action Taken with Investigational Product(s) as a result of the AE?
CL Item
Investigational Product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Subject Withdrawal
Item
Did the subject withdraw from study as a result of this AE?
boolean
Causality
Item
Is there a reasonable possibility tha the AE may have been caused by the investigational product?
boolean
Item Group
SERIOUS ADVERSE EVENTS
SAE Number
Item
SAE Number
integer
SAE Description
Item
Serious Adverse Event Description
text
Start Date and Time
Item
Start Date and Time
datetime
End Date and Time
Item
End Date and Time
datetime
Item
Outcome
text
Outcome
Code List
Outcome
CL Item
Recovered/Resolved  (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
Item
Maximum Intensity
text
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
text
Action Taken
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
CL Item
Investigational Product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Subject Withdrawn
Item
Did the subject withdraw from the study as a result of this SAE?
boolean
Causality
Item
Is there a reasonable possibility tha the AE may have been caused by the investigational product?
boolean
Was SAE study related?
Item
Was SAE cause by activities related to study participation(e.g. procedures)?
boolean
Seriousness of Event
Item
Was the event serious
boolean
Item
How serious was the SAE?
text
SAE Seriousness Level
Code List
How serious was the SAE?
CL Item
results in death (1)
CL Item
is life-threatening (2)
CL Item
requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
results in disability/incapacity (4)
CL Item
congenital anomaly/birth defect (5)
CL Item
Other (6)
Specify Other
Item
If Other, please specify
text
SAE Occurrence after study initiation
Item
Did SAE occur after initiation of study medication?
boolean
Item
Type of Report
text
Type of Report
Code List
Type of Report
CL Item
Initial (1)
CL Item
Follow-Up (2)
Item Group
RELEVANT CONCOMITANT/TREATMENT MEDICATIONS
Drug/Medication sequence number
Item
Drug/Medication sequence number
integer
Drug Name
Item
Drug Name
text
Dose
Item
Dose
text
Item
Unit
text
Unit
Code List
Unit
CL Item
Actuation (1)
CL Item
Ampoule (2)
CL Item
Application (3)
CL Item
Bottle (4)
CL Item
Capsule (5)
CL Item
Cubic centimeter (6)
CL Item
Drops (7)
CL Item
Gram (8)
CL Item
International Units (9)
CL Item
International Units per kilogram (10)
CL Item
International Units per millilitre (11)
CL Item
Litre (12)
CL Item
Litre per minute (13)
CL Item
lozenge (14)
CL Item
Megaunits (million units) (15)
CL Item
Megaunits (MCG) (16)
CL Item
Megaunits (UG) (17)
CL Item
Microgram/kilogram (18)
CL Item
Microgram/kilogram per minute (19)
CL Item
Migrograms per minute (20)
CL Item
Microlitre (21)
CL Item
Milliequvalent (22)
CL Item
Milliequvalent per 24 hours (23)
CL Item
Milligram (24)
CL Item
Milligrams percent (25)
CL Item
Milligram per hour (26)
CL Item
Milligram/kilogram (27)
CL Item
Milligram/kilogram per hour (28)
CL Item
Milligram/kilogram per minute (29)
CL Item
Milligram/metre squared (30)
CL Item
Milligram/millilitre (31)
CL Item
Millilitre (32)
CL Item
Millilitre per hour (33)
CL Item
Millilitre per minute (34)
CL Item
Millimole (35)
CL Item
Million international units (36)
CL Item
Minimum alveolar concentration (37)
CL Item
Nebule (38)
CL Item
Patch (39)
CL Item
Percent (40)
CL Item
Puff (41)
CL Item
Sachet (42)
CL Item
Spray (43)
CL Item
Suppository (44)
CL Item
Tablespoon (45)
CL Item
Tablet (46)
CL Item
Teaspoon (47)
CL Item
Units (48)
CL Item
Unknown (49)
CL Item
Vial (50)
Item
Frequency
text
Frequency
Code List
Frequency
CL Item
2 times per week (1)
CL Item
3 times per week (2)
CL Item
4 times per week (3)
CL Item
5 times per day (4)
CL Item
5 times per week (5)
CL Item
AC (6)
CL Item
BID (7)
CL Item
Continuous infusion (8)
CL Item
Every 2 weeks (9)
CL Item
Every 3 weeks (10)
CL Item
Every 3 months (11)
CL Item
Every other day (12)
CL Item
At bedtime (13)
CL Item
Once a month (14)
CL Item
Once a week (15)
CL Item
Once daily (16)
CL Item
Once only (17)
CL Item
PC (18)
CL Item
PRN (19)
CL Item
Q2H (20)
CL Item
Q3D (21)
CL Item
Q4D (22)
CL Item
Q4H (23)
CL Item
Q6H (24)
CL Item
Q8H (25)
CL Item
Q12H (26)
CL Item
QAM (27)
CL Item
QH (28)
CL Item
QID (29)
CL Item
QPM (30)
CL Item
TIO (31)
CL Item
Unknown (32)
Item
Route
text
Route
Code List
Route
CL Item
Both eyes (1)
CL Item
Epidural (2)
CL Item
Gastrostomy tube (3)
CL Item
Inhalation (4)
CL Item
Injection (5)
CL Item
Intra-arterial (6)
CL Item
Intra-bursa (7)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intranasal (10)
CL Item
Intraocular (11)
CL Item
Intraosteal (12)
CL Item
Intraperitoneal (13)
CL Item
Intrathecal (14)
CL Item
Intrauterine (15)
CL Item
Intravenous (16)
CL Item
Nasal (17)
CL Item
Oral (18)
CL Item
Rectal (19)
CL Item
Subcutaneous (20)
CL Item
Sublingual (21)
CL Item
Topical (22)
CL Item
Transdermal (23)
CL Item
Unknown (24)
CL Item
Vaginal (25)
Start Date
Item
Start Date
date
Ongoing?
Item
Ongoing?
boolean
Primary Indication
Item
Reason for Medication
text
Taken prior to Study
Item
Was the medication taken prior to Study?
boolean
Item Group
RELEVANT MEDICAL CONDITION/RISK FACTORS
Condition number
Item
Condition number
integer
Specific Condition Name
Item
Specific Condition Name
text
Start Date
Item
Date of onset
date
Item
Ongoing?
text
Ongoing?
Code List
Ongoing?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
End Date
Item
Date of last occurrence
date
Medical History
Item
Relevant Medical History / Risk Factors not noted above
text
Item Group
12-lead/Holter/Telemetry ECG
Date and Time of ECG
Item
Date and Time of ECG
datetime
Heart Rate
Item
Heart Rate
integer
PR Interval
Item
PR Interval
float
QRS Duration
Item
QRS Duration
float
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
QTc Interval
Item
QTc Interval
float
Item
Method of QTc Canculation
text
Method of QTc Canculation
Code List
Method of QTc Canculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
text
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)
Item Group
CONCOMITANT MEDICATION
Drug/Medication sequence number
Item
Drug/Medication sequence number
integer
Drug Name
Item
Drug Name
text
Dose
Item
Dose
text
Item
Unit
text
Unit
Code List
Unit
CL Item
Actuation (1)
CL Item
Ampoule (2)
CL Item
Application (3)
CL Item
Bottle (4)
CL Item
Capsule (5)
CL Item
Cubic centimeter (6)
CL Item
Drops (7)
CL Item
Gram (8)
CL Item
International Units (9)
CL Item
International Units per kilogram (10)
CL Item
International Units per millilitre (11)
CL Item
Litre (12)
CL Item
Litre per minute (13)
CL Item
lozenge (14)
CL Item
Megaunits (million units) (15)
CL Item
Megaunits (MCG) (16)
CL Item
Megaunits (UG) (17)
CL Item
Microgram/kilogram (18)
CL Item
Microgram/kilogram per minute (19)
CL Item
Migrograms per minute (20)
CL Item
Microlitre (21)
CL Item
Milliequvalent (22)
CL Item
Milliequvalent per 24 hours (23)
CL Item
Milligram (24)
CL Item
Milligrams percent (25)
CL Item
Milligram per hour (26)
CL Item
Milligram/kilogram (27)
CL Item
Milligram/kilogram per hour (28)
CL Item
Milligram/kilogram per minute (29)
CL Item
Milligram/metre squared (30)
CL Item
Milligram/millilitre (31)
CL Item
Millilitre (32)
CL Item
Millilitre per hour (33)
CL Item
Millilitre per minute (34)
CL Item
Millimole (35)
CL Item
Million international units (36)
CL Item
Minimum alveolar concentration (37)
CL Item
Nebule (38)
CL Item
Patch (39)
CL Item
Percent (40)
CL Item
Puff (41)
CL Item
Sachet (42)
CL Item
Spray (43)
CL Item
Suppository (44)
CL Item
Tablespoon (45)
CL Item
Tablet (46)
CL Item
Teaspoon (47)
CL Item
Units (48)
CL Item
Unknown (49)
CL Item
Vial (50)
Item
Frequency
text
Frequency
Code List
Frequency
CL Item
2 times per week (1)
CL Item
3 times per week (2)
CL Item
4 times per week (3)
CL Item
5 times per day (4)
CL Item
5 times per week (5)
CL Item
AC (6)
CL Item
BID (7)
CL Item
Continuous infusion (8)
CL Item
Every 2 weeks (9)
CL Item
Every 3 weeks (10)
CL Item
Every 3 months (11)
CL Item
Every other day (12)
CL Item
At bedtime (13)
CL Item
Once a month (14)
CL Item
Once a week (15)
CL Item
Once daily (16)
CL Item
Once only (17)
CL Item
PC (18)
CL Item
PRN (19)
CL Item
Q2H (20)
CL Item
Q3D (21)
CL Item
Q4D (22)
CL Item
Q4H (23)
CL Item
Q6H (24)
CL Item
Q8H (25)
CL Item
Q12H (26)
CL Item
QAM (27)
CL Item
QH (28)
CL Item
QID (29)
CL Item
QPM (30)
CL Item
TIO (31)
CL Item
Unknown (32)
Item
Route
text
Route
Code List
Route
CL Item
Both eyes (1)
CL Item
Epidural (2)
CL Item
Gastrostomy tube (3)
CL Item
Inhalation (4)
CL Item
Injection (5)
CL Item
Intra-arterial (6)
CL Item
Intra-bursa (7)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intranasal (10)
CL Item
Intraocular (11)
CL Item
Intraosteal (12)
CL Item
Intraperitoneal (13)
CL Item
Intrathecal (14)
CL Item
Intrauterine (15)
CL Item
Intravenous (16)
CL Item
Nasal (17)
CL Item
Oral (18)
CL Item
Rectal (19)
CL Item
Subcutaneous (20)
CL Item
Sublingual (21)
CL Item
Topical (22)
CL Item
Transdermal (23)
CL Item
Unknown (24)
CL Item
Vaginal (25)
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Ongoing?
Item
Ongoing?
boolean
Reason for Medication
Item
Reason for Medication
text
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
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