ID

25484

Beschreibung

Study ID: 101468/197 Clinical Study ID: SKF-101468/197 Study Title:An open study to compare the PK and tolerability of ropinirole administered as 5 different new formulations with the standard, marketed formulation in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome

Stichworte

Versionen (3)
  1. 04.09.17 04.09.17 -
  2. 04.09.17 04.09.17 -
  3. 05.09.17 05.09.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

4. September 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

screening physical examination PK and tolerability of ropinirole as 5 new formulations 101468/197

Englisch

screening physical examination PK and tolerability of ropinirole as 5 new formulations 101468/197

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Focus Panel ID
Beschreibung

focus panel

Datentyp

integer

Alias
UMLS CUI [1]
C3846158
Patient No
Beschreibung

patient number

Datentyp

integer

Alias
UMLS CUI [1]
C1830427
Date
Beschreibung

date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Body area
Beschreibung

Body area

Alias
UMLS CUI-1
C1268086
Eyes, ears, nose, mouth, throat
Beschreibung

eyes, ears, nose, mouth, throat

Datentyp

text

Alias
UMLS CUI [1]
C0015392
UMLS CUI [2]
C0013443
UMLS CUI [3]
C0028429
UMLS CUI [4]
C0230028
UMLS CUI [5]
C0031354
Eyes, ears, nose, mouth, throat
Beschreibung

Description of abnormality

Datentyp

text

Alias
UMLS CUI [1]
C0015392
UMLS CUI [2]
C0013443
UMLS CUI [3]
C0028429
UMLS CUI [4]
C0230028
UMLS CUI [5]
C0031354
Neck/Thyroid
Beschreibung

neck, thyroid

Datentyp

text

Alias
UMLS CUI [1]
C0027530
UMLS CUI [2]
C0040132
Neck/Thyroid
Beschreibung

Description of abnormality

Datentyp

text

Alias
UMLS CUI [1]
C0027530
UMLS CUI [2]
C0040132
Spine
Beschreibung

spine

Datentyp

text

Alias
UMLS CUI [1]
C0037949
Spine
Beschreibung

Description of abnormality

Datentyp

text

Alias
UMLS CUI [1]
C0037949
Chest/lungs
Beschreibung

chest, lungs

Datentyp

text

Alias
UMLS CUI [1]
C0817096
UMLS CUI [2]
C0024109
Chest/lungs
Beschreibung

Description of abnormality.

Datentyp

text

Alias
UMLS CUI [1]
C0817096
UMLS CUI [2]
C0024109
Heart
Beschreibung

heart

Datentyp

text

Alias
UMLS CUI [1]
C0018787
Heart
Beschreibung

Description of abnormality.

Datentyp

text

Alias
UMLS CUI [1]
C0018787
Vascular system
Beschreibung

vascular system

Datentyp

text

Alias
UMLS CUI [1]
C0489903
Vascular system
Beschreibung

Description of abnormality.

Datentyp

text

Alias
UMLS CUI [1]
C0489903
Lymph nodes
Beschreibung

lymph nodes

Datentyp

text

Alias
UMLS CUI [1]
C0024204
Lymph nodes
Beschreibung

Description of abnormality.

Datentyp

text

Alias
UMLS CUI [1]
C0024204
Abdomen
Beschreibung

abdomen

Datentyp

text

Alias
UMLS CUI [1]
C0000726
Abdomen
Beschreibung

Description of abnormality.

Datentyp

text

Alias
UMLS CUI [1]
C0000726
Extremities
Beschreibung

extremities

Datentyp

text

Alias
UMLS CUI [1]
C0436150
Extremities
Beschreibung

Description of abnormality.

Datentyp

text

Alias
UMLS CUI [1]
C0436150
Nervous system/ reflexes
Beschreibung

nervous system, reflexes

Datentyp

text

Alias
UMLS CUI [1]
C0027763
UMLS CUI [2]
C0034929
Nervous system/ reflexes
Beschreibung

Description of abnormality.

Datentyp

text

Alias
UMLS CUI [1]
C0027763
UMLS CUI [2]
C0034929
Skin
Beschreibung

skin

Datentyp

text

Alias
UMLS CUI [1]
C1123023
Skin
Beschreibung

Description of abnormality.

Datentyp

text

Alias
UMLS CUI [1]
C1123023
Musculoskeletal system
Beschreibung

musculoskeletal system

Datentyp

text

Alias
UMLS CUI [1]
C0026860
Musculoskeletal system
Beschreibung

Description of abnormality.

Datentyp

text

Alias
UMLS CUI [1]
C0026860
Investigator
Beschreibung

Investigator

Alias
UMLS CUI-1
C2826892
Investigator's signature
Beschreibung

investigator's signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Zum Seitenanfang zurückkehren

Ähnliche Modelle

screening physical examination PK and tolerability of ropinirole as 5 new formulations 101468/197

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
focus panel
Item
Focus Panel ID
integer
C3846158 (UMLS CUI [1])
patient number
Item
Patient No
integer
C1830427 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Body area
C1268086 (UMLS CUI-1)
Item
Eyes, ears, nose, mouth, throat
text
C0015392 (UMLS CUI [1])
C0013443 (UMLS CUI [2])
C0028429 (UMLS CUI [3])
C0230028 (UMLS CUI [4])
C0031354 (UMLS CUI [5])
eyes, ears, nose, mouth, throat
Code List
Eyes, ears, nose, mouth, throat
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
eyes, ears, nose, mouth, throat
Item
Eyes, ears, nose, mouth, throat
text
C0015392 (UMLS CUI [1])
C0013443 (UMLS CUI [2])
C0028429 (UMLS CUI [3])
C0230028 (UMLS CUI [4])
C0031354 (UMLS CUI [5])
Item
Neck/Thyroid
text
C0027530 (UMLS CUI [1])
C0040132 (UMLS CUI [2])
eyes, ears, nose, mouth, throat
Code List
Neck/Thyroid
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
neck, thyroid
Item
Neck/Thyroid
text
C0027530 (UMLS CUI [1])
C0040132 (UMLS CUI [2])
Item
Spine
text
C0037949 (UMLS CUI [1])
eyes, ears, nose, mouth, throat
Code List
Spine
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
spine
Item
Spine
text
C0037949 (UMLS CUI [1])
Item
Chest/lungs
text
C0817096 (UMLS CUI [1])
C0024109 (UMLS CUI [2])
eyes, ears, nose, mouth, throat
Code List
Chest/lungs
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
Item
Chest/lungs
text
C0817096 (UMLS CUI [1])
C0024109 (UMLS CUI [2])
eyes, ears, nose, mouth, throat
Code List
Chest/lungs
Item
Heart
text
C0018787 (UMLS CUI [1])
eyes, ears, nose, mouth, throat
Code List
Heart
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
heart
Item
Heart
text
C0018787 (UMLS CUI [1])
Item
Vascular system
text
C0489903 (UMLS CUI [1])
eyes, ears, nose, mouth, throat
Code List
Vascular system
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
vascular system
Item
Vascular system
text
C0489903 (UMLS CUI [1])
Item
Lymph nodes
text
C0024204 (UMLS CUI [1])
eyes, ears, nose, mouth, throat
Code List
Lymph nodes
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
lymph nodes
Item
Lymph nodes
text
C0024204 (UMLS CUI [1])
Item
Abdomen
text
C0000726 (UMLS CUI [1])
eyes, ears, nose, mouth, throat
Code List
Abdomen
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
abdomen
Item
Abdomen
text
C0000726 (UMLS CUI [1])
Item
Extremities
text
C0436150 (UMLS CUI [1])
eyes, ears, nose, mouth, throat
Code List
Extremities
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
extremities
Item
Extremities
text
C0436150 (UMLS CUI [1])
Item
Nervous system/ reflexes
text
C0027763 (UMLS CUI [1])
C0034929 (UMLS CUI [2])
eyes, ears, nose, mouth, throat
Code List
Nervous system/ reflexes
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
nervous system, reflexes
Item
Nervous system/ reflexes
text
C0027763 (UMLS CUI [1])
C0034929 (UMLS CUI [2])
Item
Skin
text
C1123023 (UMLS CUI [1])
eyes, ears, nose, mouth, throat
Code List
Skin
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
Item
Skin
text
C1123023 (UMLS CUI [1])
eyes, ears, nose, mouth, throat
Code List
Skin
Item
Musculoskeletal system
text
C0026860 (UMLS CUI [1])
eyes, ears, nose, mouth, throat
Code List
Musculoskeletal system
CL Item
Normal  (Normal)
CL Item
Abnormal/Pathological (Abnormal/Pathological)
CL Item
Not examined (Not examined)
musculoskeletal system
Item
Musculoskeletal system
text
C0026860 (UMLS CUI [1])
Item Group
Investigator
C2826892 (UMLS CUI-1)
investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video