ID

38602

Beschreibung

Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Stichworte

Versionen (1)
  1. 26.10.19 26.10.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

26. Oktober 2019

DOI

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Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933

Englisch

Screen - Date of Visit; Demography; Eligibility Question; Subject Identification; Randomisation Number; Nasal Endoscopy

1 Formulare  
Inform Screening
Beschreibung

Inform Screening

Alias
UMLS CUI-1
C1552002
UMLS CUI-2
C1710032
Subject initials
Beschreibung

Subject initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Inform Enrolment
Beschreibung

Inform Enrolment

Alias
UMLS CUI-1
C1552002
UMLS CUI-2
C4041024
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschreibung

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of Visit/ Assessment
Beschreibung

Date of Visit/ Assessment

Datentyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Subject Group
Beschreibung

Subject Group

Datentyp

text

Alias
UMLS CUI [1,1]
C3274381
UMLS CUI [1,2]
C2347449
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschreibung

Ethnicity

Datentyp

integer

Alias
UMLS CUI [1]
C0015031
Geography ancestry
Beschreibung

Geography ancestry

Datentyp

integer

Alias
UMLS CUI [1]
C3841890
Eligibility Question
Beschreibung

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Beschreibung

Did the subject meet all the entry criteria?

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
Subject Identification
Beschreibung

Subject Identification

Alias
UMLS CUI-1
C2348585
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Randomisation Number
Beschreibung

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Was the subject able to be randomised?
Beschreibung

Was the subject able to be randomised?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0085732
If subject was able to be randomised, provide randomisation number
Beschreibung

If subject was able to be randomised, provide randomisation number

Datentyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0085732
UMLS CUI [2,1]
C0034656
UMLS CUI [2,2]
C0237753
If subject was able to be randomised, enter date of randomisation
Beschreibung

If subject was able to be randomised, enter date of randomisation

Datentyp

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0085732
UMLS CUI [2,1]
C0034656
UMLS CUI [2,2]
C0011008
Nasal Endoscopy - Screening
Beschreibung

Nasal Endoscopy - Screening

Alias
UMLS CUI-1
C0189024
UMLS CUI-2
C0220908
Date/ time of Assessment
Beschreibung

Date/ time of Assessment

Datentyp

datetime

Alias
UMLS CUI [1]
C2985720
UMLS CUI [2,1]
C1516048
UMLS CUI [2,2]
C0040223
Nasal Endoscopy - Colour of Mucosa
Beschreibung

Nasal Endoscopy - Colour of Mucosa

Alias
UMLS CUI-1
C0189024
UMLS CUI-2
C0475705
Left Nostril Colour
Beschreibung

Left Nostril Colour

Datentyp

text

Alias
UMLS CUI [1,1]
C0475705
UMLS CUI [1,2]
C1720438
Right Nostril Colour
Beschreibung

Right Nostril Colour

Datentyp

text

Alias
UMLS CUI [1,1]
C0475705
UMLS CUI [1,2]
C1720679
Nasal Endoscopy - Turbinate Swelling
Beschreibung

Nasal Endoscopy - Turbinate Swelling

Alias
UMLS CUI-1
C0189024
UMLS CUI-2
C0038999
UMLS CUI-3
C1266928
Left nostril concha media turbinate swelling
Beschreibung

Left nostril concha media turbinate swelling

Datentyp

text

Alias
UMLS CUI [1,1]
C1266928
UMLS CUI [1,2]
C0205098
UMLS CUI [1,3]
C1720438
UMLS CUI [1,4]
C0038999
Left nostril concha inferior turbinate swelling
Beschreibung

Left nostril concha inferior turbinate swelling

Datentyp

text

Alias
UMLS CUI [1,1]
C1266928
UMLS CUI [1,2]
C0542339
UMLS CUI [1,3]
C1720438
UMLS CUI [1,4]
C0038999
Right nostril concha media turbinate swelling
Beschreibung

Right nostril concha media turbinate swelling

Datentyp

text

Alias
UMLS CUI [1,1]
C1266928
UMLS CUI [1,2]
C0205098
UMLS CUI [1,3]
C1720679
UMLS CUI [1,4]
C0038999
Right nostril concha inferior turbinate swelling
Beschreibung

Right nostril concha inferior turbinate swelling

Datentyp

text

Alias
UMLS CUI [1,1]
C1266928
UMLS CUI [1,2]
C0542339
UMLS CUI [1,3]
C1720679
UMLS CUI [1,4]
C0038999
Nasal Endoscopy - Alignment of the Septum
Beschreibung

Nasal Endoscopy - Alignment of the Septum

Alias
UMLS CUI-1
C0189024
UMLS CUI-2
C0027432
Alignment of the Septum
Beschreibung

Alignment of the Septum

Datentyp

text

Alias
UMLS CUI [1]
C0027432
Severity of right deviation
Beschreibung

Severity of right deviation

Datentyp

text

Alias
UMLS CUI [1,1]
C0232296
UMLS CUI [1,2]
C0439793
Severity of left deviation
Beschreibung

Severity of left deviation

Datentyp

text

Alias
UMLS CUI [1,1]
C0232297
UMLS CUI [1,2]
C0439793
Nasal Endoscopy - Secretions
Beschreibung

Nasal Endoscopy - Secretions

Alias
UMLS CUI-1
C0189024
UMLS CUI-2
C0036537
Left nostril secretions
Beschreibung

Left nostril secretions

Datentyp

text

Alias
UMLS CUI [1,1]
C1720438
UMLS CUI [1,2]
C0036537
Right nostril secretions
Beschreibung

Right nostril secretions

Datentyp

text

Alias
UMLS CUI [1,1]
C1720679
UMLS CUI [1,2]
C0036537
Nasal Endoscopy - Infection
Beschreibung

Nasal Endoscopy - Infection

Alias
UMLS CUI-1
C0189024
UMLS CUI-2
C0009450
Nasal infection
Beschreibung

Nasal infection

Datentyp

text

Alias
UMLS CUI [1]
C0555970
Nasal Endoscopy - Post Nasal Drip
Beschreibung

Nasal Endoscopy - Post Nasal Drip

Alias
UMLS CUI-1
C0189024
UMLS CUI-2
C1739415
Post Nasal Drip
Beschreibung

Post Nasal Drip

Datentyp

text

Alias
UMLS CUI [1]
C1739415
Nasal Endoscopy - Crusting
Beschreibung

Nasal Endoscopy - Crusting

Alias
UMLS CUI-1
C0189024
UMLS CUI-2
C0205204
Crusting
Beschreibung

Crusting

Datentyp

text

Alias
UMLS CUI [1]
C0205204
Nasal Endoscopy - Signs of Bleeding
Beschreibung

Nasal Endoscopy - Signs of Bleeding

Alias
UMLS CUI-1
C0189024
UMLS CUI-2
C0019080
Signs of Bleeding
Beschreibung

Signs of Bleeding

Datentyp

text

Alias
UMLS CUI [1]
C0019080
If signs of bleeding, specify location
Beschreibung

If signs of bleeding, specify location

Datentyp

text

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C2348235
Nasal Endoscopy - Nasal Polyps
Beschreibung

Nasal Endoscopy - Nasal Polyps

Alias
UMLS CUI-1
C0189024
UMLS CUI-2
C0027430
Presence of nasal polyps
Beschreibung

Presence of nasal polyps

Datentyp

text

Alias
UMLS CUI [1]
C0027430
If nasal polyps present, specify location
Beschreibung

If nasal polyps present, specify location

Datentyp

text

Alias
UMLS CUI [1,1]
C0027430
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C2348235
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Ähnliche Modelle

Screen - Date of Visit; Demography; Eligibility Question; Subject Identification; Randomisation Number; Nasal Endoscopy

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inform Screening
C1552002 (UMLS CUI-1)
C1710032 (UMLS CUI-2)
Subject initials
Item
Subject initials
text
C2986440 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item Group
Inform Enrolment
C1552002 (UMLS CUI-1)
C4041024 (UMLS CUI-2)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item
Subject Group
text
C3274381 (UMLS CUI [1,1])
C2347449 (UMLS CUI [1,2])
Subject Group
Code List
Subject Group
CL Item
Part 1 (P1)
CL Item
Part 2: Cohort 1 (P2C1)
CL Item
Part 2: Cohort 2 (P2C2)
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
CL Item
Female, menarcheal (1)
CL Item
Female, post-menopausal (2)
CL Item
Female, sterile (of child-bearing age) (3)
CL Item
Female, potentially able to bear children (4)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geography ancestry
integer
C3841890 (UMLS CUI [1])
Geography ancestry
Code List
Geography ancestry
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Subject Identification
C2348585 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Was the subject able to be randomised?
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
If subject was able to be randomised, provide randomisation number
Item
If subject was able to be randomised, provide randomisation number
text
C0034656 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0034656 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
If subject was able to be randomised, enter date of randomisation
Item
If subject was able to be randomised, enter date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0034656 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Item Group
Nasal Endoscopy - Screening
C0189024 (UMLS CUI-1)
C0220908 (UMLS CUI-2)
Date/ time of Assessment
Item
Date/ time of Assessment
datetime
C2985720 (UMLS CUI [1])
C1516048 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Item Group
Nasal Endoscopy - Colour of Mucosa
C0189024 (UMLS CUI-1)
C0475705 (UMLS CUI-2)
Item
Left Nostril Colour
text
C0475705 (UMLS CUI [1,1])
C1720438 (UMLS CUI [1,2])
Left Nostril Colour
Code List
Left Nostril Colour
CL Item
Normal (N)
CL Item
Abnormal, Specify colour (A)
CL Item
Abnormal, Red (R)
CL Item
Abnormal, Blue (B)
CL Item
Abnormal, White (W)
Item
Right Nostril Colour
text
C0475705 (UMLS CUI [1,1])
C1720679 (UMLS CUI [1,2])
Right Nostril Colour
Code List
Right Nostril Colour
CL Item
Normal (N)
CL Item
Abnormal, Specify colour (A)
CL Item
Abnormal, Red (R)
CL Item
Abnormal, Blue (B)
CL Item
Abnormal, White (W)
Item Group
Nasal Endoscopy - Turbinate Swelling
C0189024 (UMLS CUI-1)
C0038999 (UMLS CUI-2)
C1266928 (UMLS CUI-3)
Item
Left nostril concha media turbinate swelling
text
C1266928 (UMLS CUI [1,1])
C0205098 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
Left nostril concha media turbinate swelling
Code List
Left nostril concha media turbinate swelling
CL Item
Absent (A)
CL Item
Mild (M)
CL Item
Severe (S)
Item
Left nostril concha inferior turbinate swelling
text
C1266928 (UMLS CUI [1,1])
C0542339 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
Left nostril concha inferior turbinate swelling
Code List
Left nostril concha inferior turbinate swelling
CL Item
Absent (A)
CL Item
Mild (M)
CL Item
Severe (S)
Item
Right nostril concha media turbinate swelling
text
C1266928 (UMLS CUI [1,1])
C0205098 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
Right nostril concha media turbinate swelling
Code List
Right nostril concha media turbinate swelling
CL Item
Absent (A)
CL Item
Mild (M)
CL Item
Severe (S)
Item
Right nostril concha inferior turbinate swelling
text
C1266928 (UMLS CUI [1,1])
C0542339 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
Right nostril concha inferior turbinate swelling
Code List
Right nostril concha inferior turbinate swelling
CL Item
Absent (A)
CL Item
Mild (M)
CL Item
Severe (S)
Item Group
Nasal Endoscopy - Alignment of the Septum
C0189024 (UMLS CUI-1)
C0027432 (UMLS CUI-2)
Item
Alignment of the Septum
text
C0027432 (UMLS CUI [1])
Alignment of the Septum
Code List
Alignment of the Septum
CL Item
Normal (N)
CL Item
Right deviation (RD)
CL Item
Left deviation (LD)
Item
Severity of right deviation
text
C0232296 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Severity of right deviation
Code List
Severity of right deviation
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
Item
Severity of left deviation
text
C0232297 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Severity of left deviation
Code List
Severity of left deviation
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
Item Group
Nasal Endoscopy - Secretions
C0189024 (UMLS CUI-1)
C0036537 (UMLS CUI-2)
Item
Left nostril secretions
text
C1720438 (UMLS CUI [1,1])
C0036537 (UMLS CUI [1,2])
Left nostril secretions
Code List
Left nostril secretions
CL Item
Normal (N)
CL Item
Abnormal (A)
CL Item
Abnormal, Clear (CL)
CL Item
Abnormal, Opaque (OP)
CL Item
Abnormal, Purulent (PR)
Item
Right nostril secretions
text
C1720679 (UMLS CUI [1,1])
C0036537 (UMLS CUI [1,2])
Right nostril secretions
Code List
Right nostril secretions
CL Item
Normal  (N)
CL Item
Abnormal  (A)
CL Item
Abnormal, Clear  (CL)
CL Item
Abnormal, Opaque  (OP)
CL Item
Abnormal, Purulent (PR)
Item Group
Nasal Endoscopy - Infection
C0189024 (UMLS CUI-1)
C0009450 (UMLS CUI-2)
Item
Nasal infection
text
C0555970 (UMLS CUI [1])
Nasal infection
Code List
Nasal infection
CL Item
No infection (N)
CL Item
Viral infection (V)
CL Item
Bacterial infection (B)
Item Group
Nasal Endoscopy - Post Nasal Drip
C0189024 (UMLS CUI-1)
C1739415 (UMLS CUI-2)
Item
Post Nasal Drip
text
C1739415 (UMLS CUI [1])
Post Nasal Drip
Code List
Post Nasal Drip
CL Item
Absent (A)
CL Item
Present (P)
CL Item
Present, Clear (CL)
CL Item
Present, Opaque (OP)
CL Item
Present, Purulent (PR)
Item Group
Nasal Endoscopy - Crusting
C0189024 (UMLS CUI-1)
C0205204 (UMLS CUI-2)
Item
Crusting
text
C0205204 (UMLS CUI [1])
Crusting
Code List
Crusting
CL Item
Absent (A)
CL Item
Mild (M)
CL Item
Severe (S)
Item Group
Nasal Endoscopy - Signs of Bleeding
C0189024 (UMLS CUI-1)
C0019080 (UMLS CUI-2)
Item
Signs of Bleeding
text
C0019080 (UMLS CUI [1])
Signs of Bleeding
Code List
Signs of Bleeding
CL Item
No (N)
CL Item
Yes, specify location (Y)
If signs of bleeding, specify location
Item
If signs of bleeding, specify location
text
C0019080 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Nasal Endoscopy - Nasal Polyps
C0189024 (UMLS CUI-1)
C0027430 (UMLS CUI-2)
Item
Presence of nasal polyps
text
C0027430 (UMLS CUI [1])
Presence of nasal polyps
Code List
Presence of nasal polyps
CL Item
Absent (A)
CL Item
Yes (P)
If nasal polyps present, specify location
Item
If nasal polyps present, specify location
text
C0027430 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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