ID

36208

Description

Study ID: 101963 Clinical Study ID: SCA101963 Study Title: A randomised, blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and risperidone in healthy, non-smoking, male 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: lamotrigine Trade Name: Lamictal XR,Lamictal,LAMICTIN Study Indication: Schizophrenia

Keywords

Versions (1)
  1. 4/22/19 4/22/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 22, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Potential Pharmacokinetic Interaction between Lamotrigine and Risperidone; 101963

English

Investigational Product Discontinuation

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Investigational Product Discontinuation
Description

Investigational Product Discontinuation

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0457454
Was the investigational product stopped permanently before the end of the scheduled treatment period?
Description

Experimental drug, Discontinuation, Permanent

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0205355
If Yes, tick the primary reason the investigational product was stopped
Description

Experimental drug, Discontinuation, Permanent, Indication

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0205355
UMLS CUI [1,4]
C4288399
UMLS CUI [1,5]
C0392360
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Similar models

Investigational Product Discontinuation

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Investigational Product Discontinuation
C0304229 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Experimental drug, Discontinuation, Permanent
Item
Was the investigational product stopped permanently before the end of the scheduled treatment period?
boolean
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0205355 (UMLS CUI [1,3])
Item
If Yes, tick the primary reason the investigational product was stopped
text
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0205355 (UMLS CUI [1,3])
C4288399 (UMLS CUI [1,4])
C0392360 (UMLS CUI [1,5])
Experimental drug, Discontinuation, Permanent, Indication
Code List
If Yes, tick the primary reason the investigational product was stopped
CL Item
Adverse event (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study [6] D Sponsor terminated study (4)
CL Item
Other (5)
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