ID
40472
Description
Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome
Keywords
Versions (5)
- 4/24/20 4/24/20 -
- 4/24/20 4/24/20 -
- 4/30/20 4/30/20 -
- 5/6/20 5/6/20 -
- 5/8/20 5/8/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 24, 2020
DOI
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License
Creative Commons BY-NC 4.0
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Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218
Screen - Laboratory Collections; Urinalysis Test Results; Pregnancy Test; Alcohol Breath Test; Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies
Description
Laboratory Collections - Clinical Chemistry & Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
- UMLS CUI-3
- C0018941
Description
Laboratory Collections - Clinical Chemistry & Haematology - Exact date and time of blood sampling
Data type
datetime
Alias
- UMLS CUI [1]
- C0022885
- UMLS CUI [2]
- C0008000
- UMLS CUI [3]
- C0018941
- UMLS CUI [4,1]
- C0005834
- UMLS CUI [4,2]
- C0011008
- UMLS CUI [4,3]
- C0040223
Description
Laboratory Collections - Clinical Chemistry & Haematology - Comments
Data type
text
Alias
- UMLS CUI [1]
- C0022885
- UMLS CUI [2]
- C0008000
- UMLS CUI [3]
- C0018941
- UMLS CUI [4]
- C0947611
Description
If YES, please record diagnosis on Baseline Signs and Symptom page.
Data type
boolean
Alias
- UMLS CUI [1]
- C0022885
- UMLS CUI [2]
- C0008000
- UMLS CUI [3]
- C0018941
- UMLS CUI [4,1]
- C1853129
- UMLS CUI [4,2]
- C2826293
Description
Laboratory Collections - Drug Screening (Urine)
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0202274
Description
Laboratory Collections - Drug Screening (Urine) - Exact date end time of sampling
Data type
datetime
Alias
- UMLS CUI [1]
- C0022885
- UMLS CUI [2]
- C0202274
- UMLS CUI [3,1]
- C0870078
- UMLS CUI [3,2]
- C0011008
- UMLS CUI [3,3]
- C0040223
Description
If YES, please record all the relevant contra-indicated drugs below.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1511790
- UMLS CUI [1,2]
- C4036061
- UMLS CUI [1,3]
- C1301624
Description
Laboratory Collections - Drug Screening (Urine) - Type of drug
Data type
text
Alias
- UMLS CUI [1]
- C0022885
- UMLS CUI [2]
- C0202274
- UMLS CUI [3]
- C0457591
Description
Laboratory Collections - Drug Screening (Urine) - Comment
Data type
text
Alias
- UMLS CUI [1]
- C0022885
- UMLS CUI [2]
- C0202274
- UMLS CUI [3]
- C0947611
Description
Urinalysis Test Results
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0587081
Description
Urinalysis Test Results - Exact date and time of urine sampling
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0587081
- UMLS CUI [2,1]
- C0200354
- UMLS CUI [2,2]
- C0011008
- UMLS CUI [2,3]
- C0040223
Description
Urinalysis Test Results - Comments
Data type
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0587081
- UMLS CUI [1,3]
- C0947611
Description
If YES, please record diagnosis on Baseline Signs and Symptom page.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0587081
- UMLS CUI [2,1]
- C1853129
- UMLS CUI [2,2]
- C2826293
Description
Urinalysis Test Results - Results for dip stick test:
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0587081
- UMLS CUI-3
- C1160927
Description
Results for dip stick - Parameter
Data type
integer
Alias
- UMLS CUI [1]
- C1160927
- UMLS CUI [2]
- C0549193
Description
Result for dip stick test
Data type
text
Alias
- UMLS CUI [1,1]
- C1160927
- UMLS CUI [1,2]
- C1274040
Description
Result for dip stick test - Clinically Significant
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1160927
- UMLS CUI [1,2]
- C2826293
Description
Result for dip stick test - Comments
Data type
text
Alias
- UMLS CUI [1,1]
- C1160927
- UMLS CUI [1,2]
- C0947611
Description
Pregnancy Test (females only)
Alias
- UMLS CUI-1
- C0032976
Description
Was a pregnancy test carried out?
Data type
boolean
Alias
- UMLS CUI [1]
- C0032976
Description
If no pregnancy test was carried out, specify reason
Data type
text
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C2826287
Description
If preganancy test was carried out, indicate date of pregnancy test
Data type
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Description
If ’Positive’, withdraw the subject from the study.
Data type
integer
Alias
- UMLS CUI [1]
- C0427777
Description
Alcohol Breath Test
Alias
- UMLS CUI-1
- C0202306
Description
Was an alcohol breath test carried out?
Data type
boolean
Alias
- UMLS CUI [1]
- C0202306
Description
If no alcohol breath test was carried out, specify reason
Data type
text
Alias
- UMLS CUI [1,1]
- C0202306
- UMLS CUI [1,2]
- C2826287
Description
If alcohol breath test was carried out, indicate date of alcohol breath test
Data type
date
Alias
- UMLS CUI [1,1]
- C0202306
- UMLS CUI [1,2]
- C0011008
Description
Alcohol breath test result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0202306
- UMLS CUI [1,2]
- C0587081
Description
Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies
Alias
- UMLS CUI-1
- C0019168
- UMLS CUI-2
- C0166049
- UMLS CUI-3
- C0019683
Description
Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies - Exact date and time of blood sampling
Data type
datetime
Alias
- UMLS CUI [1]
- C0019168
- UMLS CUI [2]
- C0166049
- UMLS CUI [3]
- C0019683
- UMLS CUI [4,1]
- C0005834
- UMLS CUI [4,2]
- C0011008
- UMLS CUI [4,3]
- C0040223
Description
Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies - Comments
Data type
text
Alias
- UMLS CUI [1]
- C0019168
- UMLS CUI [2]
- C0166049
- UMLS CUI [3]
- C0019683
- UMLS CUI [4]
- C0947611
Description
Hepatitis B Surface Antigen - Was the result positive?
Data type
boolean
Alias
- UMLS CUI [1]
- C0019168
- UMLS CUI [2]
- C1514241
Description
Hepatitis C Antibodies - Was the result positive?
Data type
boolean
Alias
- UMLS CUI [1]
- C0166049
- UMLS CUI [2]
- C1514241
Description
HIVI/II Antibodies - Was the result positive?
Data type
boolean
Alias
- UMLS CUI [1]
- C0019683
- UMLS CUI [2]
- C1514241
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Screen - Laboratory Collections; Urinalysis Test Results; Pregnancy Test; Alcohol Breath Test; Hepatitis B Surface Antigen, Hepatitis C Antibodies and HIVI/II Antibodies
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C0018941 (UMLS CUI [3])
C0005834 (UMLS CUI [4,1])
C0011008 (UMLS CUI [4,2])
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C0587081 (UMLS CUI [1,2])
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C1853129 (UMLS CUI [2,1])
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C0549193 (UMLS CUI [2])
C1274040 (UMLS CUI [1,2])
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C0947611 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0166049 (UMLS CUI-2)
C0019683 (UMLS CUI-3)
C0166049 (UMLS CUI [2])
C0019683 (UMLS CUI [3])
C0005834 (UMLS CUI [4,1])
C0011008 (UMLS CUI [4,2])
C0040223 (UMLS CUI [4,3])
C0166049 (UMLS CUI [2])
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C0947611 (UMLS CUI [4])
C1514241 (UMLS CUI [2])
C1514241 (UMLS CUI [2])
C1514241 (UMLS CUI [2])