ID

35620

Description

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

Keywords

Versions (2)
  1. 3/12/19 3/12/19 -
  2. 10/30/19 10/30/19 - Sarah Riepenhausen
Copyright Holder

GSK group of companies

Uploaded on

March 12, 2019

DOI

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License

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

English

Repeating Logs

1 forms  
  1. StudyEvent: ODM
    1. Repeating Logs
Administrative data
Description

Administrative data

Date of Visit
Description

Date of Visit

Data type

date

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

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

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

Concomitant Medication

Data type

boolean

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

Non-Serious Adverse Events

Data type

boolean

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

Serious Adverse Events

Data type

boolean

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

Clinically Significant ECG Measurements

Data type

boolean

Were any repeat hematology or clinical chemistry samples taken?
Description

Repeat Hematology/ Clinical Chemistry

Data type

boolean

Were any repeat ECGs performed?
Description

Repeat ECGs

Data type

boolean

Were any repeat vital signs or temperature measurements recorded?
Description

Repeat Vital Signs / Temperature

Data type

boolean

Were any repeat PK blood samples taken?
Description

Repeat PK Blood Samples

Data type

boolean

Were any repeat Peak Nasal Inspiratory Flow tests performed?
Description

Repeat Peak Nasal Inspiratory Flow Tests

Data type

boolean

NON-SERIOUS ADVERSE EVENTS
Description

NON-SERIOUS ADVERSE EVENTS

Event Number
Description

Event Number

Data type

integer

Event Description
Description

Diagnosis or Signs/Symptoms

Data type

text

Start Date and Time
Description

Start Date and Time

Data type

datetime

End Date and Time
Description

End Date and Time

Data type

datetime

Outcome
Description

Outcome

Data type

text

Frequency
Description

Frequency

Data type

text

Maximum Intensity
Description

Maximum Intensity

Data type

text

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

Action Taken

Data type

text

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

Subject Withdrawal

Data type

boolean

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

Causality

Data type

boolean

SERIOUS ADVERSE EVENTS
Description

SERIOUS ADVERSE EVENTS

SAE Number
Description

SAE Number

Data type

integer

Serious Adverse Event Description
Description

Diagnosis or Sighs/Symptoms

Data type

text

Start Date and Time
Description

Start Date and Time

Data type

datetime

End Date and Time
Description

End Date and Time

Data type

datetime

Outcome
Description

Outcome

Data type

text

Maximum Intensity
Description

Maximum Intensity

Data type

text

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

Action Taken

Data type

text

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

Subject Withdrawn

Data type

boolean

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

Causality

Data type

boolean

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

Was SAE study related?

Data type

boolean

Was the event serious
Description

Seriousness of Event

Data type

boolean

How serious was the SAE?
Description

SAE Seriousness Level

Data type

text

If Other, please specify
Description

Specify Other

Data type

text

Did SAE occur after initiation of study medication?
Description

SAE Occurrence after study initiation

Data type

boolean

Type of Report
Description

Type of Report

Data type

text

RELEVANT CONCOMITANT/TREATMENT MEDICATIONS
Description

RELEVANT CONCOMITANT/TREATMENT MEDICATIONS

Drug/Medication sequence number
Description

Drug/Medication sequence number

Data type

integer

Drug Name
Description

Trade name preferred

Data type

text

Dose
Description

Dose

Data type

text

Unit
Description

Unit

Data type

text

Frequency
Description

Frequency

Data type

text

Route
Description

Route

Data type

text

Start Date
Description

Start Date

Data type

date

Ongoing?
Description

Ongoing?

Data type

boolean

Reason for Medication
Description

Primary Indication

Data type

text

Was the medication taken prior to Study?
Description

Taken prior to Study

Data type

boolean

RELEVANT MEDICAL CONDITION/RISK FACTORS
Description

RELEVANT MEDICAL CONDITION/RISK FACTORS

Condition number
Description

Condition number

Data type

integer

Specific Condition Name
Description

Specific Condition Name

Data type

text

Date of onset
Description

Start Date

Data type

date

Ongoing?
Description

Ongoing?

Data type

text

Date of last occurrence
Description

End Date

Data type

date

Relevant Medical History / Risk Factors not noted above
Description

Medical History

Data type

text

12-lead/Holter/Telemetry ECG
Description

12-lead/Holter/Telemetry ECG

Date and Time of ECG
Description

Date and Time of ECG

Data type

datetime

Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
PR Interval
Description

PR Interval

Data type

float

Measurement units
  • msec
msec
QRS Duration
Description

QRS Duration

Data type

float

Measurement units
  • msec
msec
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

float

Measurement units
  • msec
msec
QTc Interval
Description

QTc Interval

Data type

float

Measurement units
  • msec
msec
Method of QTc Canculation
Description

Method of QTc Canculation

Data type

text

Result of the ECG
Description

Result of the ECG

Data type

text

CONCOMITANT MEDICATION
Description

CONCOMITANT MEDICATION

Drug/Medication sequence number
Description

Drug/Medication sequence number

Data type

integer

Drug Name
Description

Trade Name preferred

Data type

text

Dose
Description

Dose

Data type

text

Unit
Description

Unit

Data type

text

Frequency
Description

Frequency

Data type

text

Route
Description

Route

Data type

text

Start Date
Description

Start Date

Data type

date

End Date
Description

End Date

Data type

date

Ongoing?
Description

Ongoing?

Data type

boolean

Reason for Medication
Description

Reason for Medication

Data type

text

Taken Prior to Study?
Description

Taken Prior to Study?

Data type

boolean

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Similar models

Repeating Logs

1 forms
  1. StudyEvent: ODM
    1. Repeating Logs
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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