ID
41822
Beschreibung
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
Stichworte
Versionen (1)
- 22.01.21 22.01.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
22. Januar 2021
DOI
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Lizenz
Creative Commons BY 4.0
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Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096)
Day 1 - Vital Signs; 12-Lead ECG; Pulmonary Function Tests; Pharmacodynamics; Local Laboratory; Urinalysis; Randomisation Number
Beschreibung
Vital Signs - Pre-Dose
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0439565
Beschreibung
Vital Signs - Date (Pre-Dose)
Datentyp
date
Alias
- UMLS CUI [1]
- C2826644
- UMLS CUI [2]
- C0439565
Beschreibung
Vital Signs - Planned Relative Time (Pre-Dose)
Datentyp
integer
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2,1]
- C0439564
- UMLS CUI [2,2]
- C1301732
- UMLS CUI [3]
- C0439565
Beschreibung
Vital Signs - Actual Time (Pre-Dose)
Datentyp
time
Alias
- UMLS CUI [1]
- C2826762
- UMLS CUI [2]
- C0439565
Beschreibung
Vital Signs - Systolic Blood Pressure (Pre-Dose)
Datentyp
integer
Maßeinheiten
- mm[Hg]
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0871470
- UMLS CUI [3]
- C0439565
Beschreibung
Vital Signs - Diastolic Blood Pressure (Pre-Dose)
Datentyp
integer
Maßeinheiten
- mm[Hg]
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0428883
- UMLS CUI [3]
- C0439565
Beschreibung
Vital Signs - Heart Rate (Pre-Dose)
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0018810
- UMLS CUI [3]
- C0439565
Beschreibung
12-Lead ECG (Pre-Dose)
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0439565
Beschreibung
Start Date of ECG (Pre-Dose)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2]
- C0439565
Beschreibung
12-Lead ECG - Planned Relative Time (Pre-Dose)
Datentyp
integer
Alias
- UMLS CUI [1]
- C0430456
- UMLS CUI [2,1]
- C0439564
- UMLS CUI [2,2]
- C1301732
- UMLS CUI [3]
- C0439565
Beschreibung
Start Time of ECG (Pre-Dose)
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
- UMLS CUI [2]
- C0439565
Beschreibung
12-Lead ECG - Ventricular Rate (Pre-Dose)
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2189285
- UMLS CUI [2]
- C0439565
Beschreibung
12-Lead ECG - PR Interval (Pre-Dose)
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
- UMLS CUI [2]
- C0439565
Beschreibung
12-Lead ECG - QRS Duration (Pre-Dose)
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
- UMLS CUI [2]
- C0439565
Beschreibung
12-Lead ECG - Uncorrected QT Interval (Pre-Dose)
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
- UMLS CUI [2]
- C0439565
Beschreibung
12-Lead ECG - QTc Interval (Pre-Dose)
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
- UMLS CUI [2]
- C0439565
Beschreibung
12-Lead ECG - Result (Pre-Dose)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [2]
- C0439565
Beschreibung
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Beschreibung
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Beschreibung
A. Rhythm
Datentyp
text
Alias
- UMLS CUI [1]
- C0232187
Beschreibung
Other abnormal rhythm - Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C0947611
Beschreibung
B. P-Wave and QRS Morphology
Datentyp
text
Alias
- UMLS CUI [1]
- C2216025
- UMLS CUI [2]
- C0429098
Beschreibung
Other P-Wave and QRS Morphology - Comment
Datentyp
text
Alias
- UMLS CUI [1]
- C2216025
- UMLS CUI [2]
- C0429098
- UMLS CUI [3]
- C0205394
- UMLS CUI [4]
- C0947611
Beschreibung
C. Conduction
Datentyp
text
Alias
- UMLS CUI [1]
- C0232217
Beschreibung
Other Conduction - Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C0947611
Beschreibung
D. Myocaridal Infarction
Datentyp
text
Alias
- UMLS CUI [1]
- C0027051
Beschreibung
Other Myocardial Infarction - Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C0947611
Beschreibung
E. Depolarisation/ Repolarisation (QRS-T)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1395184
- UMLS CUI [1,2]
- C0948857
Beschreibung
Other Depolarisation/ Repolarisation (QRS-T) - Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1395184
- UMLS CUI [1,2]
- C0948857
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C0947611
Beschreibung
Other abnormalities
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
Beschreibung
Other abnormalities - Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C0947611
Beschreibung
Pulmonary Function Tests (Pre-Dose)
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0439565
Beschreibung
Pulmonary Function Tests - Date (Pre-Dose)
Datentyp
date
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0011008
- UMLS CUI [3]
- C0439565
Beschreibung
Pulmonary Function Test (Pre-Dose)
Datentyp
integer
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0439565
Beschreibung
Pulmonary Function Tests - Units (Pre-Dose)
Datentyp
integer
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C1519795
- UMLS CUI [3]
- C0439565
Beschreibung
Pulmonary Function Tests - Planned Relative Time (Pre-Dose)
Datentyp
integer
Alias
- UMLS CUI [1]
- C0439564
- UMLS CUI [2]
- C0024119
- UMLS CUI [3]
- C0439565
Beschreibung
Pulmonary Function Tests - Actual Time of First Reading (Pre-Dose)
Datentyp
time
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0040223
- UMLS CUI [3]
- C0439565
Beschreibung
Pulmonary Function Tests - Reading 1 (Pre-Dose)
Datentyp
float
Maßeinheiten
- L
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0243095
- UMLS CUI [3]
- C0439565
Beschreibung
Pulmonary Function Tests - Reading 2 (Pre-Dose)
Datentyp
float
Maßeinheiten
- L
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0243095
- UMLS CUI [3]
- C0439565
Beschreibung
Pulmonary Function Tests - Reading 3 (Pre-Dose)
Datentyp
float
Maßeinheiten
- L
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2]
- C0243095
- UMLS CUI [3]
- C0439565
Beschreibung
Pharmacodynamics - Blood Sample (Pre-Dose)
Alias
- UMLS CUI-1
- C0851347
- UMLS CUI-3
- C0178913
- UMLS CUI-5
- C0439565
Beschreibung
Pharmacodynamics - Planned Relative Time (Pre-Dose)
Datentyp
text
Alias
- UMLS CUI [1]
- C0851347
- UMLS CUI [2]
- C0439564
- UMLS CUI [3]
- C1301732
- UMLS CUI [4]
- C0439565
Beschreibung
Pharmacodynamics - Date sample taken (Pre-Dose)
Datentyp
date
Alias
- UMLS CUI [1]
- C0851347
- UMLS CUI [2]
- C1302413
- UMLS CUI [3]
- C0439565
Beschreibung
Pharmacodynamics - Actual Time (Pre-Dose)
Datentyp
time
Alias
- UMLS CUI [1]
- C0851347
- UMLS CUI [2]
- C0040223
- UMLS CUI [3]
- C0439565
Beschreibung
Pharmacodynamics - Sample Number (Pre-Dose)
Datentyp
integer
Alias
- UMLS CUI [1]
- C0851347
- UMLS CUI [2]
- C1299222
- UMLS CUI [3]
- C0439565
Beschreibung
Local Laboratory - Clinical Chemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
Beschreibung
Local Laboratory - Clinical Chemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
Beschreibung
Clinical Chemistry Test
Datentyp
text
Alias
- UMLS CUI [1]
- C0525044
Beschreibung
If the laboratory results meet the protocol definition of an adverse event, record the details on the Non-Serious Adverse Events page or Serious Adverse Event page.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0587081
Beschreibung
Local Laboratory - Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Beschreibung
Local Laboratory - Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Beschreibung
Haematology Test
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018941
Beschreibung
If the laboratory results meet the protocol definition of an adverse event, record the details in the Non-Serious Adverse Events or Serious Adverse Event section(s).
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0587081
Beschreibung
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
Beschreibung
Date and time sample taken (Urinalysis)
Datentyp
datetime
Alias
- UMLS CUI [1]
- C0042014
- UMLS CUI [2,1]
- C0200345
- UMLS CUI [2,2]
- C1264639
Beschreibung
Result of dipstick
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Beschreibung
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
Beschreibung
Urinalysis Test
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0022885
Beschreibung
Urinalysis Test Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0587081
Beschreibung
Urinalysis Microscopy Test
Alias
- UMLS CUI-1
- C0430397
Beschreibung
Urinalysis Microscopy Test
Alias
- UMLS CUI-1
- C0430397
Beschreibung
Urinalysis Microscopy Test
Datentyp
integer
Alias
- UMLS CUI [1]
- C0430397
Beschreibung
Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) section(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0587081
Beschreibung
Randomisation Number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Ähnliche Modelle
Day 1 - Vital Signs; 12-Lead ECG; Pulmonary Function Tests; Pharmacodynamics; Local Laboratory; Urinalysis; Randomisation Number
C0439565 (UMLS CUI-2)
C0439565 (UMLS CUI [2])
C0439564 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0439565 (UMLS CUI [3])
C0439565 (UMLS CUI [2])
C0871470 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0428883 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0018810 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0439565 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C0439564 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0439565 (UMLS CUI [3])
C1301880 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C2189285 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C0429087 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C0429025 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C1287082 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C0855331 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C1274040 (UMLS CUI [1,2])
C0439565 (UMLS CUI [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])
C0439565 (UMLS CUI-2)
C0011008 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0439565 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0024119 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0040223 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0243095 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0243095 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0243095 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0178913 (UMLS CUI-3)
C0439565 (UMLS CUI-5)
C0439564 (UMLS CUI [2])
C1301732 (UMLS CUI [3])
C0439565 (UMLS CUI [4])
C1302413 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0040223 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C1299222 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0008000 (UMLS CUI-2)
C0200345 (UMLS CUI [2])
C1264639 (UMLS CUI [3])
C0008000 (UMLS CUI-2)
C0587081 (UMLS CUI [1,2])
C0474523 (UMLS CUI-2)
C0870078 (UMLS CUI [2])
C1264639 (UMLS CUI [3])
C0474523 (UMLS CUI-2)
C0587081 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
C0587081 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])