ID
41885
Beskrivning
Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma
Nyckelord
Versioner (3)
- 2021-01-27 2021-01-27 -
- 2021-02-08 2021-02-08 -
- 2021-02-08 2021-02-08 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
8 februari 2021
DOI
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Licens
Creative Commons BY 4.0
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Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096)
Treatment Period 1- 5 - Investigational Product; Treatment Confirmation; Carbon Monoxide Test; Urine Test for Drugs of Abuse; Vital Signs; 12-Lead ECG; Pulmonary Function Test
Beskrivning
Investigational Product Day 1 - 7
Alias
- UMLS CUI-1
- C0304229
Beskrivning
Planned Timepoint
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C2348792
- UMLS CUI [1,3]
- C1301732
Beskrivning
Investigational Product
Datatyp
integer
Alias
- UMLS CUI [1]
- C0304229
Beskrivning
Investigational Product Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beskrivning
Investigational Product Start Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1301880
Beskrivning
Investigational Prosuct Stop Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beskrivning
Investigational Product Stop Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522314
Beskrivning
Investigational Product Dose
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0678766
Beskrivning
Investigational Product Units
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1519795
Beskrivning
Treatment Corfirmation Day 1 - 7
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0750484
Beskrivning
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0087111
Beskrivning
If subject did not receive the correct treatment, record reason(s)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C2349182
- UMLS CUI [1,3]
- C0392360
Beskrivning
Carbon Monoxide Test - Day 6 PM
Alias
- UMLS CUI-1
- C0007018
- UMLS CUI-2
- C0022885
Beskrivning
Carbon Monoxide Test - Date sample taken
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0007018
- UMLS CUI [1,2]
- C1302413
Beskrivning
Carbon Monoxide Test - Results
Datatyp
integer
Måttenheter
- ppm
Alias
- UMLS CUI [1,1]
- C0007018
- UMLS CUI [1,2]
- C0587081
Beskrivning
Carbon Monoxide Test - Results
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0007018
- UMLS CUI [1,2]
- C0587081
Beskrivning
Urine Test for Drugs of Abuse
Alias
- UMLS CUI-1
- C0202274
Beskrivning
Urine Test for Drugs of Abuse
Alias
- UMLS CUI-1
- C0202274
Beskrivning
Urine Test for Drugs of Abuse
Datatyp
integer
Alias
- UMLS CUI [1]
- C0202274
Beskrivning
Vital Signs - Day 7
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Vital Signs - Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826644
Beskrivning
Vital Signs - Planned Relative Time
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Beskrivning
Vital Signs - Actual Time
Datatyp
time
Alias
- UMLS CUI [1]
- C2826762
Beskrivning
Vital Signs - Systolic Blood Pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0871470
Beskrivning
Vital Signs - Diastolic Blood Pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0428883
Beskrivning
Vital Signs - Heart Rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
Beskrivning
12-Lead ECG - Day 7
Alias
- UMLS CUI-1
- C0430456
Beskrivning
Start Date of ECG
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Beskrivning
12-Lead ECG - Planned Relative Time
Datatyp
integer
Alias
- UMLS CUI [1]
- C0430456
- UMLS CUI [2,1]
- C0439564
- UMLS CUI [2,2]
- C1301732
Beskrivning
Start Time of ECG
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Beskrivning
12-Lead ECG - Ventricular Rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2189285
Beskrivning
12-Lead ECG - PR Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Beskrivning
12-Lead ECG - QRS Duration
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Beskrivning
12-Lead ECG - Uncorrected QT Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Beskrivning
12-Lead ECG - QTc Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Beskrivning
12-Lead ECG - Result
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Beskrivning
12-Lead ECG Abnormalities - Day 7
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Beskrivning
12-Lead ECG Abnormalities - Day 7
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Beskrivning
A. Rhythm
Datatyp
text
Alias
- UMLS CUI [1]
- C0232187
Beskrivning
Other abnormal rhythm - Comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C0947611
Beskrivning
B. P-Wave and QRS Morphology
Datatyp
text
Alias
- UMLS CUI [1]
- C2216025
- UMLS CUI [2]
- C0429098
Beskrivning
Other P-Wave and QRS Morphology - Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C2216025
- UMLS CUI [2]
- C0429098
- UMLS CUI [3]
- C0205394
- UMLS CUI [4]
- C0947611
Beskrivning
C. Conduction
Datatyp
text
Alias
- UMLS CUI [1]
- C0232217
Beskrivning
Other Conduction - Comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C0947611
Beskrivning
D. Myocaridal Infarction
Datatyp
text
Alias
- UMLS CUI [1]
- C0027051
Beskrivning
Other Myocardial Infarction - Comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C0947611
Beskrivning
E. Depolarisation/ Repolarisation (QRS-T)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1395184
- UMLS CUI [1,2]
- C0948857
Beskrivning
Other Depolarisation/ Repolarisation (QRS-T) - Comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1395184
- UMLS CUI [1,2]
- C0948857
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C0947611
Beskrivning
Other abnormalities
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
Beskrivning
Other abnormalities - Comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C0947611
Beskrivning
Pulmonary Function Test - Day 7
Alias
- UMLS CUI-1
- C0024119
Beskrivning
Pulmonary Function Tests - Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0011008
Beskrivning
Pulmonary Function Test
Datatyp
integer
Alias
- UMLS CUI [1]
- C0024119
Beskrivning
Pulmonary Function Tests - Units
Datatyp
integer
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C1519795
Beskrivning
Pulmonary Function Tests - Planned Relative Time
Datatyp
integer
Alias
- UMLS CUI [1]
- C0439564
- UMLS CUI [2]
- C0024119
Beskrivning
Pulmonary Function Tests - Actual Time of First Reading
Datatyp
time
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0040223
Beskrivning
Pulmonary Function Tests - Reading 1
Datatyp
float
Måttenheter
- L
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0243095
Beskrivning
Pulmonary Function Tests - Reading 2
Datatyp
float
Måttenheter
- L
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0243095
Beskrivning
Pulmonary Function Tests - Reading 3
Datatyp
float
Måttenheter
- L
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0243095
Similar models
Treatment Period 1- 5 - Investigational Product; Treatment Confirmation; Carbon Monoxide Test; Urine Test for Drugs of Abuse; Vital Signs; 12-Lead ECG; Pulmonary Function Test
C2348792 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0678766 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C0750484 (UMLS CUI-2)
C0087111 (UMLS CUI [1,2])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0022885 (UMLS CUI-2)
C1302413 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0871470 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0439564 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C1301880 (UMLS CUI [1,2])
C2189285 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C1704258 (UMLS CUI-2)
C0013798 (UMLS CUI [1,2])
C1704258 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C0429098 (UMLS CUI [2])
C0429098 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C0947611 (UMLS CUI [4])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C0948857 (UMLS CUI [1,2])
C0948857 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C0011008 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
C0024119 (UMLS CUI [2])
C0040223 (UMLS CUI [2])
C0243095 (UMLS CUI [2])
C0243095 (UMLS CUI [2])
C0243095 (UMLS CUI [2])