ID

43804

Beschrijving

StaccatoTM Loxapine for Inhalation in Schizophrenic Patients With Agitation.; ODM derived from: https://clinicaltrials.gov/show/NCT00369577

Link

https://clinicaltrials.gov/show/NCT00369577

Trefwoorden

Versies (2)
  1. 21-06-17 21-06-17 -
  2. 20-09-21 20-09-21 -
Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00369577

Engels

Eligibility Schizophrenia NCT00369577

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male and female patients between the ages of 18 to 65 years, inclusive.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. patients who have met dsm-iv criteria for schizophrenia, schizophreniform disorder, or schizoaffective disorder.
Beschrijving

Schizophrenia | Schizophreniform Disorders | Schizoaffective Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036358
UMLS CUI [3]
C0036337
3. patients who are judged to be clinically agitated at baseline with a total score of ≥
Beschrijving

Agitation

Datatype

boolean

Alias
UMLS CUI [1]
C0085631
14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the panss excited component (pec).
Beschrijving

PANSS - Poor Impulse Control | PANSS - Tension | PANSS - Hostility | PANSS - Uncooperativeness | PANSS - Excitement

Datatype

boolean

Alias
UMLS CUI [1]
C4086704
UMLS CUI [2]
C4086709
UMLS CUI [3]
C4086697
UMLS CUI [4]
C4086710
UMLS CUI [5]
C4086693
4. patients who have a value of ≥ 4 (out of 7) on at least 1 of the 5 items on the panss excited component.
Beschrijving

PANSS - Excitement

Datatype

boolean

Alias
UMLS CUI [1]
C4086693
5. patients who read and understand english and provide written informed consent.
Beschrijving

Able to read English Language | Comprehension English Language | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0376245
UMLS CUI [3]
C0021430
6. patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ecg, blood chemistry profile, hematology, urinalysis and in the opinion of the principal investigator.
Beschrijving

General health good | Medical History | Physical Examination | 12 lead ECG | Blood Chemical Analysis | Hematology procedure | Urinalysis

Datatype

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0430456
UMLS CUI [5]
C0005774
UMLS CUI [6]
C0200627
UMLS CUI [7]
C0042014
7. female participants, if of child-bearing potential and sexually active, and male participants, if sexually active with a partner of child-bearing potential, who agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study. medically acceptable methods of contraception that may be used by the participant and/or his/her partner include abstinence, birth control pills or patches, diaphragm with spermicide, intrauterine device (iud), condom with foam or spermicide, vaginal spermicidal suppository, surgical sterilization and progestin implant or injection. prohibited methods include: the rhythm method, withdrawal, condoms alone, or diaphragm alone.
Beschrijving

Sexually active Contraceptive methods | Childbearing Potential Contraceptive methods | Partner Childbearing Potential Contraceptive methods | Sexual Abstinence | Contraceptives, Oral | Contraceptive Patch | Vaginal contraceptive diaphragm | Vaginal Spermicides | Intrauterine Devices | Female Condoms | Spermicidal foam/jelly/cream/film/suppository | Female Sterilization | Progestin-containing Intrauterine Device | Rhythm method Excluded | Withdrawal Excluded

Datatype

boolean

Alias
UMLS CUI [1,1]
C0241028
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C0682323
UMLS CUI [3,2]
C3831118
UMLS CUI [3,3]
C0700589
UMLS CUI [4]
C0036899
UMLS CUI [5]
C0009905
UMLS CUI [6]
C2985284
UMLS CUI [7]
C0042241
UMLS CUI [8]
C0087145
UMLS CUI [9]
C0021900
UMLS CUI [10]
C0221829
UMLS CUI [11]
C3843415
UMLS CUI [12]
C0015787
UMLS CUI [13]
C2917409
UMLS CUI [14,1]
C0035513
UMLS CUI [14,2]
C2828389
UMLS CUI [15,1]
C3812880
UMLS CUI [15,2]
C2828389
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with agitation caused by acute intoxication must be excluded. positive identification of non-prescription drugs during urine screening excludes the subject.
Beschrijving

Agitation caused by Intoxication | Drugs, Non-Prescription | Urine screening

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085631
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0728899
UMLS CUI [2]
C0013231
UMLS CUI [3]
C0595946
2. patients treated with benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotics within 4 hours prior to study drug administration must be excluded.
Beschrijving

Benzodiazepines | Hypnotics | Antipsychotic Agents Oral | Antipsychotic Agents Intramuscular Active short-term

Datatype

boolean

Alias
UMLS CUI [1]
C0005064
UMLS CUI [2]
C0020591
UMLS CUI [3,1]
C0040615
UMLS CUI [3,2]
C1527415
UMLS CUI [4,1]
C0040615
UMLS CUI [4,2]
C1556154
UMLS CUI [4,3]
C0205177
UMLS CUI [4,4]
C0443303
3. patients treated with injectable depot neuroleptics within one dose interval prior to study drug administration must be excluded.
Beschrijving

Neuroleptics Depot Preparations Injectable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0086129
UMLS CUI [1,3]
C0086466
4. patients with a history of allergic reactions to loxapine or amoxapine must be excluded.
Beschrijving

Loxapine allergy | Amoxapine allergy

Datatype

boolean

Alias
UMLS CUI [1]
C0570835
UMLS CUI [2]
C0570749
5. female patients who have a positive pregnancy test at screening or are breastfeeding must be excluded.
Beschrijving

Gender Pregnancy test positive | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0240802
UMLS CUI [2]
C0006147
6. patients who have parkinson's disease, hydrocephalus, seizure disorder, or history of significant head trauma must be excluded.
Beschrijving

Parkinson Disease | Hydrocephalus | Epilepsy | Craniocerebral Trauma

Datatype

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2]
C0020255
UMLS CUI [3]
C0014544
UMLS CUI [4]
C0018674
7. patients with laboratory or ecg abnormalities considered clinically significant by the investigator or qualified designee that would have clinical implications for the patient's participation in the study must be excluded.
Beschrijving

Laboratory test result abnormal Effect Study Subject Participation Status | ECG abnormality Effect Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C1280500
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0522055
UMLS CUI [2,2]
C1280500
UMLS CUI [2,3]
C2348568
8. patients with serious and unstable illnesses including current hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and congestive heart failure), endocrinologic, neurologic (including stroke, transient ischemic attack, subarachnoidal bleeding, brain tumor, encephalopathy, and meningitis), or hematologic disease must be excluded.
Beschrijving

Illness Serious | Illness Unstable | Liver diseases | Kidney Diseases | Gastroenterology Disease | Respiration Disorders | Cardiovascular Diseases | Myocardial Ischemia | Congestive heart failure | Endocrine System Diseases | nervous system disorder | Cerebrovascular accident | Transient Ischemic Attack | Subarachnoid Hemorrhage | Brain Neoplasms | Encephalopathy | Meningitis | Hematological Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5,1]
C0017163
UMLS CUI [5,2]
C0012634
UMLS CUI [6]
C0035204
UMLS CUI [7]
C0007222
UMLS CUI [8]
C0151744
UMLS CUI [9]
C0018802
UMLS CUI [10]
C0014130
UMLS CUI [11]
C0027765
UMLS CUI [12]
C0038454
UMLS CUI [13]
C0007787
UMLS CUI [14]
C0038525
UMLS CUI [15]
C0006118
UMLS CUI [16]
C0085584
UMLS CUI [17]
C0025289
UMLS CUI [18]
C0018939
9. patients who have a history of acute or chronic pulmonary disease that precludes administration of staccato loxapine (asthma, bronchitis, emphysema) must be excluded.
Beschrijving

Lung disease Excludes Adasuve | Chronic pulmonary disease | Asthma | Bronchitis | Pulmonary Emphysema

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C3530455
UMLS CUI [2]
C0810290
UMLS CUI [3]
C0004096
UMLS CUI [4]
C0006277
UMLS CUI [5]
C0034067
10. patients who have received an investigational drug within 30 days prior to the current agitation episode must be excluded.
Beschrijving

Investigational New Drugs Before Episode of Agitation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0332189
UMLS CUI [1,4]
C0085631
11. patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving loxapine, or unable to use the inhalation device, must be excluded.
Beschrijving

Loxapine | Patient Inappropriate | Inhalation Device Use Unable

Datatype

boolean

Alias
UMLS CUI [1]
C0024056
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [3,1]
C0021455
UMLS CUI [3,2]
C1524063
UMLS CUI [3,3]
C1299582
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Similar models

Eligibility Schizophrenia NCT00369577

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male and female patients between the ages of 18 to 65 years, inclusive.
boolean
C0001779 (UMLS CUI [1])
Schizophrenia | Schizophreniform Disorders | Schizoaffective Disorder
Item
2. patients who have met dsm-iv criteria for schizophrenia, schizophreniform disorder, or schizoaffective disorder.
boolean
C0036341 (UMLS CUI [1])
C0036358 (UMLS CUI [2])
C0036337 (UMLS CUI [3])
Agitation
Item
3. patients who are judged to be clinically agitated at baseline with a total score of ≥
boolean
C0085631 (UMLS CUI [1])
PANSS - Poor Impulse Control | PANSS - Tension | PANSS - Hostility | PANSS - Uncooperativeness | PANSS - Excitement
Item
14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the panss excited component (pec).
boolean
C4086704 (UMLS CUI [1])
C4086709 (UMLS CUI [2])
C4086697 (UMLS CUI [3])
C4086710 (UMLS CUI [4])
C4086693 (UMLS CUI [5])
PANSS - Excitement
Item
4. patients who have a value of ≥ 4 (out of 7) on at least 1 of the 5 items on the panss excited component.
boolean
C4086693 (UMLS CUI [1])
Able to read English Language | Comprehension English Language | Informed Consent
Item
5. patients who read and understand english and provide written informed consent.
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0233733 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3])
General health good | Medical History | Physical Examination | 12 lead ECG | Blood Chemical Analysis | Hematology procedure | Urinalysis
Item
6. patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ecg, blood chemistry profile, hematology, urinalysis and in the opinion of the principal investigator.
boolean
C1277245 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0430456 (UMLS CUI [4])
C0005774 (UMLS CUI [5])
C0200627 (UMLS CUI [6])
C0042014 (UMLS CUI [7])
Sexually active Contraceptive methods | Childbearing Potential Contraceptive methods | Partner Childbearing Potential Contraceptive methods | Sexual Abstinence | Contraceptives, Oral | Contraceptive Patch | Vaginal contraceptive diaphragm | Vaginal Spermicides | Intrauterine Devices | Female Condoms | Spermicidal foam/jelly/cream/film/suppository | Female Sterilization | Progestin-containing Intrauterine Device | Rhythm method Excluded | Withdrawal Excluded
Item
7. female participants, if of child-bearing potential and sexually active, and male participants, if sexually active with a partner of child-bearing potential, who agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study. medically acceptable methods of contraception that may be used by the participant and/or his/her partner include abstinence, birth control pills or patches, diaphragm with spermicide, intrauterine device (iud), condom with foam or spermicide, vaginal spermicidal suppository, surgical sterilization and progestin implant or injection. prohibited methods include: the rhythm method, withdrawal, condoms alone, or diaphragm alone.
boolean
C0241028 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0682323 (UMLS CUI [3,1])
C3831118 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C0036899 (UMLS CUI [4])
C0009905 (UMLS CUI [5])
C2985284 (UMLS CUI [6])
C0042241 (UMLS CUI [7])
C0087145 (UMLS CUI [8])
C0021900 (UMLS CUI [9])
C0221829 (UMLS CUI [10])
C3843415 (UMLS CUI [11])
C0015787 (UMLS CUI [12])
C2917409 (UMLS CUI [13])
C0035513 (UMLS CUI [14,1])
C2828389 (UMLS CUI [14,2])
C3812880 (UMLS CUI [15,1])
C2828389 (UMLS CUI [15,2])
Item Group
C0680251 (UMLS CUI)
Agitation caused by Intoxication | Drugs, Non-Prescription | Urine screening
Item
1. patients with agitation caused by acute intoxication must be excluded. positive identification of non-prescription drugs during urine screening excludes the subject.
boolean
C0085631 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0728899 (UMLS CUI [1,3])
C0013231 (UMLS CUI [2])
C0595946 (UMLS CUI [3])
Benzodiazepines | Hypnotics | Antipsychotic Agents Oral | Antipsychotic Agents Intramuscular Active short-term
Item
2. patients treated with benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotics within 4 hours prior to study drug administration must be excluded.
boolean
C0005064 (UMLS CUI [1])
C0020591 (UMLS CUI [2])
C0040615 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0040615 (UMLS CUI [4,1])
C1556154 (UMLS CUI [4,2])
C0205177 (UMLS CUI [4,3])
C0443303 (UMLS CUI [4,4])
Neuroleptics Depot Preparations Injectable
Item
3. patients treated with injectable depot neuroleptics within one dose interval prior to study drug administration must be excluded.
boolean
C0040615 (UMLS CUI [1,1])
C0086129 (UMLS CUI [1,2])
C0086466 (UMLS CUI [1,3])
Loxapine allergy | Amoxapine allergy
Item
4. patients with a history of allergic reactions to loxapine or amoxapine must be excluded.
boolean
C0570835 (UMLS CUI [1])
C0570749 (UMLS CUI [2])
Gender Pregnancy test positive | Breast Feeding
Item
5. female patients who have a positive pregnancy test at screening or are breastfeeding must be excluded.
boolean
C0079399 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
Parkinson Disease | Hydrocephalus | Epilepsy | Craniocerebral Trauma
Item
6. patients who have parkinson's disease, hydrocephalus, seizure disorder, or history of significant head trauma must be excluded.
boolean
C0030567 (UMLS CUI [1])
C0020255 (UMLS CUI [2])
C0014544 (UMLS CUI [3])
C0018674 (UMLS CUI [4])
Laboratory test result abnormal Effect Study Subject Participation Status | ECG abnormality Effect Study Subject Participation Status
Item
7. patients with laboratory or ecg abnormalities considered clinically significant by the investigator or qualified designee that would have clinical implications for the patient's participation in the study must be excluded.
boolean
C0438215 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0522055 (UMLS CUI [2,1])
C1280500 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Illness Serious | Illness Unstable | Liver diseases | Kidney Diseases | Gastroenterology Disease | Respiration Disorders | Cardiovascular Diseases | Myocardial Ischemia | Congestive heart failure | Endocrine System Diseases | nervous system disorder | Cerebrovascular accident | Transient Ischemic Attack | Subarachnoid Hemorrhage | Brain Neoplasms | Encephalopathy | Meningitis | Hematological Disease
Item
8. patients with serious and unstable illnesses including current hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and congestive heart failure), endocrinologic, neurologic (including stroke, transient ischemic attack, subarachnoidal bleeding, brain tumor, encephalopathy, and meningitis), or hematologic disease must be excluded.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0017163 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0035204 (UMLS CUI [6])
C0007222 (UMLS CUI [7])
C0151744 (UMLS CUI [8])
C0018802 (UMLS CUI [9])
C0014130 (UMLS CUI [10])
C0027765 (UMLS CUI [11])
C0038454 (UMLS CUI [12])
C0007787 (UMLS CUI [13])
C0038525 (UMLS CUI [14])
C0006118 (UMLS CUI [15])
C0085584 (UMLS CUI [16])
C0025289 (UMLS CUI [17])
C0018939 (UMLS CUI [18])
Lung disease Excludes Adasuve | Chronic pulmonary disease | Asthma | Bronchitis | Pulmonary Emphysema
Item
9. patients who have a history of acute or chronic pulmonary disease that precludes administration of staccato loxapine (asthma, bronchitis, emphysema) must be excluded.
boolean
C0024115 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C3530455 (UMLS CUI [1,3])
C0810290 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
C0006277 (UMLS CUI [4])
C0034067 (UMLS CUI [5])
Investigational New Drugs Before Episode of Agitation
Item
10. patients who have received an investigational drug within 30 days prior to the current agitation episode must be excluded.
boolean
C0013230 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C0085631 (UMLS CUI [1,4])
Loxapine | Patient Inappropriate | Inhalation Device Use Unable
Item
11. patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving loxapine, or unable to use the inhalation device, must be excluded.
boolean
C0024056 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0021455 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
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