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ID
35620
Descrição
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
Palavras-chave
Versões (2)
- 12/03/2019 12/03/2019 -
- 30/10/2019 30/10/2019 - Sarah Riepenhausen
Titular dos direitos
GSK group of companies
Transferido a
12 de março de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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The effect of intranasal capsaicin challenge model in healthy volunteers - 111611
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Repeating Logs
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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
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
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Single episode (1)
CL Item
Intermittent (2)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
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
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
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
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
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
CL Item
Initial (1)
CL Item
Follow-Up (2)
Drug/Medication sequence number
Item
Drug/Medication sequence number
integer
Drug Name
Item
Drug Name
text
Dose
Item
Dose
text
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
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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)
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
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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)
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
Condition number
Item
Condition number
integer
Specific Condition Name
Item
Specific Condition Name
text
Start Date
Item
Date of onset
date
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
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
CL Item
Machine (1)
CL Item
Manual (2)
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)
Drug/Medication sequence number
Item
Drug/Medication sequence number
integer
Drug Name
Item
Drug Name
text
Dose
Item
Dose
text
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)
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)
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