ID
38699
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)
- 3/12/19 3/12/19 -
- 10/30/19 10/30/19 - Sarah Riepenhausen
Copyright Holder
GSK group of companies
Uploaded on
October 30, 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
Repeating Logs
- StudyEvent: ODM
Description
Adverse Event/Concomitant Medications/Repeat Assessment (Check Questions)
Description
Concomitant Medication
Data type
boolean
Description
Non-Serious Adverse Events
Data type
boolean
Description
Serious Adverse Events
Data type
boolean
Description
Clinically Significant ECG Measurements
Data type
boolean
Description
Repeat Hematology/ Clinical Chemistry
Data type
boolean
Description
Repeat ECGs
Data type
boolean
Description
Repeat Vital Signs / Temperature
Data type
boolean
Description
Repeat PK Blood Samples
Data type
boolean
Description
Repeat Peak Nasal Inspiratory Flow Tests
Data type
boolean
Description
NON-SERIOUS ADVERSE EVENTS
Description
Event Number
Data type
integer
Description
Diagnosis or Signs/Symptoms
Data type
text
Description
Start Date and Time
Data type
datetime
Description
End Date and Time
Data type
datetime
Description
Outcome
Data type
text
Description
Frequency
Data type
text
Description
Maximum Intensity
Data type
text
Description
Action Taken
Data type
text
Description
Subject Withdrawal
Data type
boolean
Description
Causality
Data type
boolean
Description
SERIOUS ADVERSE EVENTS
Description
SAE Number
Data type
integer
Description
Diagnosis or Sighs/Symptoms
Data type
text
Description
Start Date and Time
Data type
datetime
Description
End Date and Time
Data type
datetime
Description
Outcome
Data type
text
Description
Maximum Intensity
Data type
text
Description
Action Taken
Data type
text
Description
Subject Withdrawn
Data type
boolean
Description
Causality
Data type
boolean
Description
Was SAE study related?
Data type
boolean
Description
Seriousness of Event
Data type
boolean
Description
SAE Seriousness Level
Data type
text
Description
Specify Other
Data type
text
Description
SAE Occurrence after study initiation
Data type
boolean
Description
Type of Report
Data type
text
Description
RELEVANT CONCOMITANT/TREATMENT MEDICATIONS
Description
Drug/Medication sequence number
Data type
integer
Description
Trade name preferred
Data type
text
Description
Dose
Data type
text
Description
Unit
Data type
text
Description
Frequency
Data type
text
Description
Route
Data type
text
Description
Start Date
Data type
date
Description
Ongoing?
Data type
boolean
Description
Primary Indication
Data type
text
Description
Taken prior to Study
Data type
boolean
Description
RELEVANT MEDICAL CONDITION/RISK FACTORS
Description
Condition number
Data type
integer
Description
Specific Condition Name
Data type
text
Description
Start Date
Data type
date
Description
Ongoing?
Data type
text
Description
End Date
Data type
date
Description
Medical History
Data type
text
Description
12-lead/Holter/Telemetry ECG
Description
Date and Time of ECG
Data type
datetime
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
PR Interval
Data type
float
Measurement units
- msec
Description
QRS Duration
Data type
float
Measurement units
- msec
Description
Uncorrected QT Interval
Data type
float
Measurement units
- msec
Description
QTc Interval
Data type
float
Measurement units
- msec
Description
Method of QTc Canculation
Data type
text
Description
Result of the ECG
Data type
text
Description
CONCOMITANT MEDICATION
Description
Drug/Medication sequence number
Data type
integer
Description
Trade Name preferred
Data type
text
Description
Dose
Data type
text
Description
Unit
Data type
text
Description
Frequency
Data type
text
Description
Route
Data type
text
Description
Start Date
Data type
date
Description
End Date
Data type
date
Description
Ongoing?
Data type
boolean
Description
Reason for Medication
Data type
text
Description
Taken Prior to Study?
Data type
boolean
Similar models
Repeating Logs
- StudyEvent: ODM