ID

32026

Descrição

An Efficacy and Safety Study of Paliperidone Extended-Release (ER) Tablets in Participants With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00566631

Link

https://clinicaltrials.gov/show/NCT00566631

Palavras-chave

Versões (1)
  1. 14/10/2018 14/10/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

14 de outubro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00566631

Inglês

Eligibility Schizophrenia NCT00566631

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
meets the diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) criteria for schizophrenia
Descrição

Schizophrenia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0036341
must be experiencing an acute schizophrenic episode with a positive and negative syndrome scale (panss) total score of greater than or equal to 70 at baseline
Descrição

Acute schizophrenic episode PANSS

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0813173
UMLS CUI [1,2]
C4086747
must be admitted to hospital for treatment of the acute schizophrenic episode and must agree for voluntary hospitalization for at least the first 7 days of the study
Descrição

Hospital admission Acute schizophrenic episode | HOSPITALIZATION VOLUNTARY Duration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C0813173
UMLS CUI [2,1]
C0745044
UMLS CUI [2,2]
C0449238
female participants must be postmenopausal (for at least 1 year), surgically sterile, abstinent, or, if sexually active, be practicing and effective method of birth control (example, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study and female participants of child-bearing potential must have a negative urine pregnancy test at screening
Descrição

Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods | Prescription Oral Contraceptives | Contraceptive injection | Intrauterine Devices | Barrier Contraception Double | Contraceptive patch | Partner had vasectomy | Childbearing Potential Urine pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0036899
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0241028
UMLS CUI [4,3]
C0700589
UMLS CUI [5,1]
C0033080
UMLS CUI [5,2]
C0009905
UMLS CUI [6]
C1656586
UMLS CUI [7]
C0021900
UMLS CUI [8,1]
C0004764
UMLS CUI [8,2]
C0205173
UMLS CUI [9]
C2985284
UMLS CUI [10]
C0420842
UMLS CUI [11,1]
C3831118
UMLS CUI [11,2]
C0430057
participants or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Descrição

Informed Consent | Informed Consent Patient Representatives

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast-feeding female participants
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
first antipsychotic treatment ever
Descrição

Antipsychotic drug therapy First

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1319421
UMLS CUI [1,2]
C0205435
have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment and on clozapine or a long-acting injectable antipsychotic during the last 3 months
Descrição

Investigational New Drugs | Investigational Medical Device | Clozapine | Antipsychotic Agent Injectable Active Long-term

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
UMLS CUI [3]
C0009079
UMLS CUI [4,1]
C0040615
UMLS CUI [4,2]
C0086466
UMLS CUI [4,3]
C0205177
UMLS CUI [4,4]
C0443252
known hypersensitivity to paliperidone extended-release (er) or risperidone
Descrição

Hypersensitivity Paliperidone ER | Risperidone allergy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C4058551
UMLS CUI [2]
C0570837
relevant history of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic diseases, history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome including recent or present clinically relevant laboratory abnormalities (as deemed by the investigator) and participants with current or known history (over the past 6 months) of substance dependence according to dsm-iv criteria
Descrição

Cardiovascular Diseases | Respiration Disorders | Nervous system disorder | Seizures | Cerebrovascular Disorders | Kidney Diseases | Liver diseases | Endocrine System Diseases | Immune System Diseases | Cardiovascular Diseases Unstable | Respiration Disorders Unstable | Nervous system disorder Unstable | Seizures Unstable | Cerebrovascular Disorders Unstable | Kidney Diseases Unstable | Liver diseases Unstable | Endocrine System Diseases Unstable | Immune System Diseases Unstable | Tardive Dyskinesia | Symptoms Tardive Dyskinesia | Neuroleptic Malignant Syndrome | Laboratory test result abnormal | Substance Dependence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0035204
UMLS CUI [3]
C0027765
UMLS CUI [4]
C0036572
UMLS CUI [5]
C0007820
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0023895
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0021053
UMLS CUI [10,1]
C0007222
UMLS CUI [10,2]
C0443343
UMLS CUI [11,1]
C0035204
UMLS CUI [11,2]
C0443343
UMLS CUI [12,1]
C0027765
UMLS CUI [12,2]
C0443343
UMLS CUI [13,1]
C0036572
UMLS CUI [13,2]
C0443343
UMLS CUI [14,1]
C0007820
UMLS CUI [14,2]
C0443343
UMLS CUI [15,1]
C0022658
UMLS CUI [15,2]
C0443343
UMLS CUI [16,1]
C0023895
UMLS CUI [16,2]
C0443343
UMLS CUI [17,1]
C0014130
UMLS CUI [17,2]
C0443343
UMLS CUI [18,1]
C0021053
UMLS CUI [18,2]
C0443343
UMLS CUI [19]
C0686347
UMLS CUI [20,1]
C1457887
UMLS CUI [20,2]
C0686347
UMLS CUI [21]
C0027849
UMLS CUI [22]
C0438215
UMLS CUI [23]
C0038580
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Similar models

Eligibility Schizophrenia NCT00566631

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
meets the diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) criteria for schizophrenia
boolean
C0036341 (UMLS CUI [1])
Acute schizophrenic episode PANSS
Item
must be experiencing an acute schizophrenic episode with a positive and negative syndrome scale (panss) total score of greater than or equal to 70 at baseline
boolean
C0813173 (UMLS CUI [1,1])
C4086747 (UMLS CUI [1,2])
Hospital admission Acute schizophrenic episode | HOSPITALIZATION VOLUNTARY Duration
Item
must be admitted to hospital for treatment of the acute schizophrenic episode and must agree for voluntary hospitalization for at least the first 7 days of the study
boolean
C0184666 (UMLS CUI [1,1])
C0813173 (UMLS CUI [1,2])
C0745044 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods | Prescription Oral Contraceptives | Contraceptive injection | Intrauterine Devices | Barrier Contraception Double | Contraceptive patch | Partner had vasectomy | Childbearing Potential Urine pregnancy test negative
Item
female participants must be postmenopausal (for at least 1 year), surgically sterile, abstinent, or, if sexually active, be practicing and effective method of birth control (example, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study and female participants of child-bearing potential must have a negative urine pregnancy test at screening
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0241028 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
C0033080 (UMLS CUI [5,1])
C0009905 (UMLS CUI [5,2])
C1656586 (UMLS CUI [6])
C0021900 (UMLS CUI [7])
C0004764 (UMLS CUI [8,1])
C0205173 (UMLS CUI [8,2])
C2985284 (UMLS CUI [9])
C0420842 (UMLS CUI [10])
C3831118 (UMLS CUI [11,1])
C0430057 (UMLS CUI [11,2])
Informed Consent | Informed Consent Patient Representatives
Item
participants or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding female participants
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Antipsychotic drug therapy First
Item
first antipsychotic treatment ever
boolean
C1319421 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
Investigational New Drugs | Investigational Medical Device | Clozapine | Antipsychotic Agent Injectable Active Long-term
Item
have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment and on clozapine or a long-acting injectable antipsychotic during the last 3 months
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0009079 (UMLS CUI [3])
C0040615 (UMLS CUI [4,1])
C0086466 (UMLS CUI [4,2])
C0205177 (UMLS CUI [4,3])
C0443252 (UMLS CUI [4,4])
Hypersensitivity Paliperidone ER | Risperidone allergy
Item
known hypersensitivity to paliperidone extended-release (er) or risperidone
boolean
C0020517 (UMLS CUI [1,1])
C4058551 (UMLS CUI [1,2])
C0570837 (UMLS CUI [2])
Cardiovascular Diseases | Respiration Disorders | Nervous system disorder | Seizures | Cerebrovascular Disorders | Kidney Diseases | Liver diseases | Endocrine System Diseases | Immune System Diseases | Cardiovascular Diseases Unstable | Respiration Disorders Unstable | Nervous system disorder Unstable | Seizures Unstable | Cerebrovascular Disorders Unstable | Kidney Diseases Unstable | Liver diseases Unstable | Endocrine System Diseases Unstable | Immune System Diseases Unstable | Tardive Dyskinesia | Symptoms Tardive Dyskinesia | Neuroleptic Malignant Syndrome | Laboratory test result abnormal | Substance Dependence
Item
relevant history of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic diseases, history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome including recent or present clinically relevant laboratory abnormalities (as deemed by the investigator) and participants with current or known history (over the past 6 months) of substance dependence according to dsm-iv criteria
boolean
C0007222 (UMLS CUI [1])
C0035204 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0036572 (UMLS CUI [4])
C0007820 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0021053 (UMLS CUI [9])
C0007222 (UMLS CUI [10,1])
C0443343 (UMLS CUI [10,2])
C0035204 (UMLS CUI [11,1])
C0443343 (UMLS CUI [11,2])
C0027765 (UMLS CUI [12,1])
C0443343 (UMLS CUI [12,2])
C0036572 (UMLS CUI [13,1])
C0443343 (UMLS CUI [13,2])
C0007820 (UMLS CUI [14,1])
C0443343 (UMLS CUI [14,2])
C0022658 (UMLS CUI [15,1])
C0443343 (UMLS CUI [15,2])
C0023895 (UMLS CUI [16,1])
C0443343 (UMLS CUI [16,2])
C0014130 (UMLS CUI [17,1])
C0443343 (UMLS CUI [17,2])
C0021053 (UMLS CUI [18,1])
C0443343 (UMLS CUI [18,2])
C0686347 (UMLS CUI [19])
C1457887 (UMLS CUI [20,1])
C0686347 (UMLS CUI [20,2])
C0027849 (UMLS CUI [21])
C0438215 (UMLS CUI [22])
C0038580 (UMLS CUI [23])
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