ID

14071

Description

Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years); ODM derived from: https://clinicaltrials.gov/show/NCT01155700

Link

https://clinicaltrials.gov/show/NCT01155700

Keywords

Versions (1)
  1. 3/24/16 3/24/16 -
Uploaded on

March 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Allergic Asthma NCT01155700

English

Eligibility Allergic Asthma NCT01155700

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
body weight and serum total ige level within the dosing table range; body weight of 20 to 150 kg and serum total ige levels of 30 to 1300 iu/ml
Description

Body weight | serum IgE measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C2229760
receiving asthma long-term control medications of high dose ics (>200 µg/day fp or equivalent) and two or more controller medications out of ltra, theophylline, sodium cromoglycate, laba, or ocss 12 weeks prior to the run-in period. these medications should be kept stable for 4 weeks prior to the run-in period and during the run-in period (except for management of asthma attacks/exacerbations)
Description

Asthma | Inhaled steroids | Oral steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2065041
UMLS CUI [1,3]
C3537183
UMLS CUI [2]
C0039771
UMLS CUI [3]
C0012694
UMLS CUI [4]
C2936789
UMLS CUI [5,1]
C0574135
UMLS CUI [5,2]
C0349790
having 2 or more asthma exacerbations requiring treatment with a doubling of the maintenance ics dose for at least 3 days and/or systemic (oral or iv) corticosteroids in the past; one of these exacerbations must have occurred in the previous 12 months, which is documented in the medical record
Description

Asthma exacerbation | Inhaled steroids | Systemic steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C2065041
UMLS CUI [1,3]
C2825233
UMLS CUI [1,4]
C0574135
UMLS CUI [2]
C0563322
demonstrating inadequately controlled asthma symptoms during the last 14 day run-in period based on the patient diary which meet any of the following:
Description

Asthma | Uncontrolled | Patient diary

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C3890583
asthma symptoms every day; night-time symptoms in ≥2 out of the last 14 days (missing data to be treated as a day with no symptoms); limitation of daily activities in ≥2 out of the last 14 days (missing data to be treated as a day with no limitations)
Description

Asthma daytime symptoms | Asthma night-time symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C1276804
UMLS CUI [1,2]
C1273489
UMLS CUI [1,3]
C0871707
UMLS CUI [1,4]
C0439801
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
with a history of food or drug related severe anaphylactoid or anaphylactic reaction(s)
Description

Food anaphylaxis | Drug-induced anaphylactoid reaction

Data type

boolean

Alias
UMLS CUI [1]
C0685898
UMLS CUI [2]
C0344178
with positive skin reaction to the study drug at the run-in period
Description

Positive skin test reaction | Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C0302021
UMLS CUI [1,2]
C0013227
with known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study drug or drug related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin)
Description

Drug Allergy | Omalizumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0038636
UMLS CUI [2]
C0019602
UMLS CUI [3]
C0032600
UMLS CUI [4]
C0966225
UMLS CUI [5]
C0003250
UMLS CUI [6]
C1328603
with platelet level ≤ 100,000/µl (100 x 109/l) at the run-in period
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
who are taking intra-muscular depo-steroids within 4 weeks of the run-in period
Description

Intramuscular steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0585373
who are taking systemic (oral or iv) corticosteroids for reasons other than asthma within 4 weeks of the run-in period (patients with chronic ocss use for asthma are allowed)
Description

Systemic steroid therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C4039704
UMLS CUI [1,2]
C0574135
UMLS CUI [2,1]
C0563322
UMLS CUI [2,2]
C0004096
other protocol-defined inclusion/exclusion criteria may apply
Description

Inclusion | Exclusion

Data type

boolean

Alias
UMLS CUI [1]
C1512693
UMLS CUI [2]
C2828389
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Similar models

Eligibility Allergic Asthma NCT01155700

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Body weight | serum IgE measurement
Item
body weight and serum total ige level within the dosing table range; body weight of 20 to 150 kg and serum total ige levels of 30 to 1300 iu/ml
boolean
C0005910 (UMLS CUI [1,1])
C2229760 (UMLS CUI [1,2])
Asthma | Inhaled steroids | Oral steroids
Item
receiving asthma long-term control medications of high dose ics (>200 µg/day fp or equivalent) and two or more controller medications out of ltra, theophylline, sodium cromoglycate, laba, or ocss 12 weeks prior to the run-in period. these medications should be kept stable for 4 weeks prior to the run-in period and during the run-in period (except for management of asthma attacks/exacerbations)
boolean
C0004096 (UMLS CUI [1,1])
C2065041 (UMLS CUI [1,2])
C3537183 (UMLS CUI [1,3])
C0039771 (UMLS CUI [2])
C0012694 (UMLS CUI [3])
C2936789 (UMLS CUI [4])
C0574135 (UMLS CUI [5,1])
C0349790 (UMLS CUI [5,2])
Asthma exacerbation | Inhaled steroids | Systemic steroids
Item
having 2 or more asthma exacerbations requiring treatment with a doubling of the maintenance ics dose for at least 3 days and/or systemic (oral or iv) corticosteroids in the past; one of these exacerbations must have occurred in the previous 12 months, which is documented in the medical record
boolean
C0349790 (UMLS CUI [1,1])
C2065041 (UMLS CUI [1,2])
C2825233 (UMLS CUI [1,3])
C0574135 (UMLS CUI [1,4])
C0563322 (UMLS CUI [2])
Asthma | Uncontrolled | Patient diary
Item
demonstrating inadequately controlled asthma symptoms during the last 14 day run-in period based on the patient diary which meet any of the following:
boolean
C0004096 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C3890583 (UMLS CUI [1,3])
Asthma daytime symptoms | Asthma night-time symptoms
Item
asthma symptoms every day; night-time symptoms in ≥2 out of the last 14 days (missing data to be treated as a day with no symptoms); limitation of daily activities in ≥2 out of the last 14 days (missing data to be treated as a day with no limitations)
boolean
C1276804 (UMLS CUI [1,1])
C1273489 (UMLS CUI [1,2])
C0871707 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Food anaphylaxis | Drug-induced anaphylactoid reaction
Item
with a history of food or drug related severe anaphylactoid or anaphylactic reaction(s)
boolean
C0685898 (UMLS CUI [1])
C0344178 (UMLS CUI [2])
Positive skin test reaction | Pharmaceutical Preparations
Item
with positive skin reaction to the study drug at the run-in period
boolean
C0302021 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Drug Allergy | Omalizumab
Item
with known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study drug or drug related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin)
boolean
C0013182 (UMLS CUI [1,1])
C0038636 (UMLS CUI [1,2])
C0019602 (UMLS CUI [2])
C0032600 (UMLS CUI [3])
C0966225 (UMLS CUI [4])
C0003250 (UMLS CUI [5])
C1328603 (UMLS CUI [6])
Platelet Count measurement
Item
with platelet level ≤ 100,000/µl (100 x 109/l) at the run-in period
boolean
C0032181 (UMLS CUI [1])
Intramuscular steroid therapy
Item
who are taking intra-muscular depo-steroids within 4 weeks of the run-in period
boolean
C0585373 (UMLS CUI [1])
Systemic steroid therapy
Item
who are taking systemic (oral or iv) corticosteroids for reasons other than asthma within 4 weeks of the run-in period (patients with chronic ocss use for asthma are allowed)
boolean
C4039704 (UMLS CUI [1,1])
C0574135 (UMLS CUI [1,2])
C0563322 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
Inclusion | Exclusion
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1512693 (UMLS CUI [1])
C2828389 (UMLS CUI [2])
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