ID

32112

Description

Phase 4 Study to Evaluate Efficacy of Paliperidone Extended-Release(ER) in Schizophrenic Participants; ODM derived from: https://clinicaltrials.gov/show/NCT00761605

Link

https://clinicaltrials.gov/show/NCT00761605

Keywords

Versions (1)
  1. 10/18/18 10/18/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 18, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00761605

English

Eligibility Schizophrenia NCT00761605

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
childbearing potential women who consent to the use of the consistently permissible contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
Description

Childbearing Potential Contraceptive methods | Contraceptives, Oral | Contraceptive injection | Intrauterine Devices | Barrier Contraception Double | Contraceptive patch

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0009905
UMLS CUI [3]
C1656586
UMLS CUI [4]
C0021900
UMLS CUI [5,1]
C0004764
UMLS CUI [5,2]
C0205173
UMLS CUI [6]
C2985284
participants who are compliant with self-medication or can receive consistent help or support
Description

Compliance behavior Self Medication | Ability Receive Support

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0036600
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C1521721
participants who need to change the antipsychotic drug to another one for the following reasons among the participants treated with an antipsychotic drug for more than two weeks before the screening (1) group of lack of efficacy: the antipsychotic drug is clinically required to be changed because there is no or little therapeutic response despite the appropriately dosed antipsychotic therapy (2) group of lack of tolerance: the antipsychotic drug is required to be changed due to lack of tolerance to the existing antipsychotic drug or the safety issue (3) group of lack of compliance: the antipsychotic drug is required to be changed due to lack of medication compliance or the participant wants to change the antipsychotic drug)
Description

Antipsychotic Agents | Patient need for Change Antipsychotic Agent | Etiology aspects | Lack of Efficacy | Intolerance to substance | Safety Lacking | Medication Compliance Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0040615
UMLS CUI [3]
C0015127
UMLS CUI [4]
C0235828
UMLS CUI [5]
C1744706
UMLS CUI [6,1]
C0036043
UMLS CUI [6,2]
C0332268
UMLS CUI [7,1]
C3489773
UMLS CUI [7,2]
C0332268
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants with the past history of neuroleptic malignant syndrome (nms)
Description

Neuroleptic Malignant Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0027849
participants who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study (based on the investigator's judgment)
Description

Risk Clinical Significance | At risk for suicide | At risk Aggressive behavior | Completion of clinical trial Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0563664
UMLS CUI [3,1]
C1444641
UMLS CUI [3,2]
C0001807
UMLS CUI [4,1]
C2732579
UMLS CUI [4,2]
C1299582
participants with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or participants who cannot swallow the drug whole (the study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile
Description

Gastrointestinal stenosis Pre-existing Severe | Gastrointestinal stenosis Pre-existing Severe Iatrogenic | Lacking Able to swallow Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0521587
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C0521587
UMLS CUI [2,2]
C2347662
UMLS CUI [2,3]
C0205082
UMLS CUI [2,4]
C0439669
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C2712086
UMLS CUI [3,3]
C0013230
female participants who are pregnant or are breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participants who have participated in any investigational drug trial within 1 month prior to the screening visit
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Schizophrenia NCT00761605

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Childbearing Potential Contraceptive methods | Contraceptives, Oral | Contraceptive injection | Intrauterine Devices | Barrier Contraception Double | Contraceptive patch
Item
childbearing potential women who consent to the use of the consistently permissible contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0009905 (UMLS CUI [2])
C1656586 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0004764 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
C2985284 (UMLS CUI [6])
Compliance behavior Self Medication | Ability Receive Support
Item
participants who are compliant with self-medication or can receive consistent help or support
boolean
C1321605 (UMLS CUI [1,1])
C0036600 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C1521721 (UMLS CUI [2,3])
Antipsychotic Agents | Patient need for Change Antipsychotic Agent | Etiology aspects | Lack of Efficacy | Intolerance to substance | Safety Lacking | Medication Compliance Lacking
Item
participants who need to change the antipsychotic drug to another one for the following reasons among the participants treated with an antipsychotic drug for more than two weeks before the screening (1) group of lack of efficacy: the antipsychotic drug is clinically required to be changed because there is no or little therapeutic response despite the appropriately dosed antipsychotic therapy (2) group of lack of tolerance: the antipsychotic drug is required to be changed due to lack of tolerance to the existing antipsychotic drug or the safety issue (3) group of lack of compliance: the antipsychotic drug is required to be changed due to lack of medication compliance or the participant wants to change the antipsychotic drug)
boolean
C0040615 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0040615 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3])
C0235828 (UMLS CUI [4])
C1744706 (UMLS CUI [5])
C0036043 (UMLS CUI [6,1])
C0332268 (UMLS CUI [6,2])
C3489773 (UMLS CUI [7,1])
C0332268 (UMLS CUI [7,2])
Item Group
C0680251 (UMLS CUI)
Neuroleptic Malignant Syndrome
Item
participants with the past history of neuroleptic malignant syndrome (nms)
boolean
C0027849 (UMLS CUI [1])
Risk Clinical Significance | At risk for suicide | At risk Aggressive behavior | Completion of clinical trial Unable
Item
participants who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study (based on the investigator's judgment)
boolean
C0035647 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0563664 (UMLS CUI [2])
C1444641 (UMLS CUI [3,1])
C0001807 (UMLS CUI [3,2])
C2732579 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])
Gastrointestinal stenosis Pre-existing Severe | Gastrointestinal stenosis Pre-existing Severe Iatrogenic | Lacking Able to swallow Investigational New Drugs
Item
participants with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or participants who cannot swallow the drug whole (the study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile
boolean
C0521587 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0521587 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0439669 (UMLS CUI [2,4])
C0332268 (UMLS CUI [3,1])
C2712086 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
female participants who are pregnant or are breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
participants who have participated in any investigational drug trial within 1 month prior to the screening visit
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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