ID
41885
Beschrijving
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
Trefwoorden
Versies (3)
- 27-01-21 27-01-21 -
- 08-02-21 08-02-21 -
- 08-02-21 08-02-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
8 februari 2021
DOI
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Licentie
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
Beschrijving
Investigational Product Day 1 - 7
Alias
- UMLS CUI-1
- C0304229
Beschrijving
Planned Timepoint
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C2348792
- UMLS CUI [1,3]
- C1301732
Beschrijving
Investigational Product
Datatype
integer
Alias
- UMLS CUI [1]
- C0304229
Beschrijving
Investigational Product Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschrijving
Investigational Product Start Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1301880
Beschrijving
Investigational Prosuct Stop Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschrijving
Investigational Product Stop Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522314
Beschrijving
Investigational Product Dose
Datatype
float
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0678766
Beschrijving
Investigational Product Units
Datatype
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1519795
Beschrijving
Treatment Corfirmation Day 1 - 7
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0750484
Beschrijving
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0087111
Beschrijving
If subject did not receive the correct treatment, record reason(s)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C2349182
- UMLS CUI [1,3]
- C0392360
Beschrijving
Carbon Monoxide Test - Day 6 PM
Alias
- UMLS CUI-1
- C0007018
- UMLS CUI-2
- C0022885
Beschrijving
Carbon Monoxide Test - Date sample taken
Datatype
date
Alias
- UMLS CUI [1,1]
- C0007018
- UMLS CUI [1,2]
- C1302413
Beschrijving
Carbon Monoxide Test - Results
Datatype
integer
Maateenheden
- ppm
Alias
- UMLS CUI [1,1]
- C0007018
- UMLS CUI [1,2]
- C0587081
Beschrijving
Carbon Monoxide Test - Results
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0007018
- UMLS CUI [1,2]
- C0587081
Beschrijving
Urine Test for Drugs of Abuse
Alias
- UMLS CUI-1
- C0202274
Beschrijving
Urine Test for Drugs of Abuse
Alias
- UMLS CUI-1
- C0202274
Beschrijving
Urine Test for Drugs of Abuse
Datatype
integer
Alias
- UMLS CUI [1]
- C0202274
Beschrijving
Vital Signs - Day 7
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Vital Signs - Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826644
Beschrijving
Vital Signs - Planned Relative Time
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Beschrijving
Vital Signs - Actual Time
Datatype
time
Alias
- UMLS CUI [1]
- C2826762
Beschrijving
Vital Signs - Systolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0871470
Beschrijving
Vital Signs - Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0428883
Beschrijving
Vital Signs - Heart Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
Beschrijving
12-Lead ECG - Day 7
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Start Date of ECG
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Beschrijving
12-Lead ECG - Planned Relative Time
Datatype
integer
Alias
- UMLS CUI [1]
- C0430456
- UMLS CUI [2,1]
- C0439564
- UMLS CUI [2,2]
- C1301732
Beschrijving
Start Time of ECG
Datatype
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Beschrijving
12-Lead ECG - Ventricular Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2189285
Beschrijving
12-Lead ECG - PR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Beschrijving
12-Lead ECG - QRS Duration
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Beschrijving
12-Lead ECG - Uncorrected QT Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Beschrijving
12-Lead ECG - QTc Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Beschrijving
12-Lead ECG - Result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Beschrijving
12-Lead ECG Abnormalities - Day 7
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Beschrijving
12-Lead ECG Abnormalities - Day 7
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Beschrijving
A. Rhythm
Datatype
text
Alias
- UMLS CUI [1]
- C0232187
Beschrijving
Other abnormal rhythm - Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C0947611
Beschrijving
B. P-Wave and QRS Morphology
Datatype
text
Alias
- UMLS CUI [1]
- C2216025
- UMLS CUI [2]
- C0429098
Beschrijving
Other P-Wave and QRS Morphology - Comment
Datatype
text
Alias
- UMLS CUI [1]
- C2216025
- UMLS CUI [2]
- C0429098
- UMLS CUI [3]
- C0205394
- UMLS CUI [4]
- C0947611
Beschrijving
C. Conduction
Datatype
text
Alias
- UMLS CUI [1]
- C0232217
Beschrijving
Other Conduction - Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C0947611
Beschrijving
D. Myocaridal Infarction
Datatype
text
Alias
- UMLS CUI [1]
- C0027051
Beschrijving
Other Myocardial Infarction - Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C0947611
Beschrijving
E. Depolarisation/ Repolarisation (QRS-T)
Datatype
text
Alias
- UMLS CUI [1,1]
- C1395184
- UMLS CUI [1,2]
- C0948857
Beschrijving
Other Depolarisation/ Repolarisation (QRS-T) - Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C1395184
- UMLS CUI [1,2]
- C0948857
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C0947611
Beschrijving
Other abnormalities
Datatype
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
Beschrijving
Other abnormalities - Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C0947611
Beschrijving
Pulmonary Function Test - Day 7
Alias
- UMLS CUI-1
- C0024119
Beschrijving
Pulmonary Function Tests - Date
Datatype
date
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0011008
Beschrijving
Pulmonary Function Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0024119
Beschrijving
Pulmonary Function Tests - Units
Datatype
integer
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C1519795
Beschrijving
Pulmonary Function Tests - Planned Relative Time
Datatype
integer
Alias
- UMLS CUI [1]
- C0439564
- UMLS CUI [2]
- C0024119
Beschrijving
Pulmonary Function Tests - Actual Time of First Reading
Datatype
time
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0040223
Beschrijving
Pulmonary Function Tests - Reading 1
Datatype
float
Maateenheden
- L
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0243095
Beschrijving
Pulmonary Function Tests - Reading 2
Datatype
float
Maateenheden
- L
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0243095
Beschrijving
Pulmonary Function Tests - Reading 3
Datatype
float
Maateenheden
- 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])