ID
13067
Beskrivning
Prospective,multicentric,double blind and placebo-controlled Phase III clinical trial to determine efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in patients with allergic rhinoconjunctivits caused by grass or rye pollen. EudraCT-Nr. 2008-000513-29 Study-code:CLU-2008-001 Sponsor: ROXALL Medizin GmbH Carl-Petersen-Straße 4 20535 Hamburg Phone:040-8972520 Fax:040-89725223 Project coordinator: Dr.Jenny Uhlig ROXALL Medizin GmbH Head of clinical investigation: Prof.Dr.med.Ludger Klimek An den Quellen 10 65183 Wiesbaden Phone:0611-8904381 Fax:0611-3082360 Monitoring,data management and statistical evaluation: IMSIE- Institut for medical statistics,computer sciences and epidemiology University hospital Cologne Lindenburger Allee 42 50931 Cologne Phone:0221-4783456 Fax:0221-4783465
Nyckelord
Versioner (1)
- 2016-01-14 2016-01-14 -
Uppladdad den
14 januari 2016
DOI
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Licens
Creative Commons BY-NC 3.0
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Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis 1.0
Case report form Visit 1
- StudyEvent: ODM
Beskrivning
Exclusion criteria
Beskrivning
Study subject participation status
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Beskrivning
hyposensitization
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0178702
Beskrivning
perennial rhinitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0035457
Beskrivning
Asthma
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004096
Beskrivning
Inflammation or Infection
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021368
- UMLS CUI [2]
- C3714514
Beskrivning
Emphysema or bronchiectasis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0034067
- UMLS CUI [2]
- C0006267
Beskrivning
Tuberculosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0041296
Beskrivning
Autoimmune diseases
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004364
Beskrivning
Chronic inflammatory diseases
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1290886
Beskrivning
Malignancies
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0006826
Beskrivning
Substance use disorder
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0038586
Beskrivning
psychotropic drugs or tranquilizer
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0033978
- UMLS CUI [2]
- C0020592
Beskrivning
Anti-IgE Antibodies
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0051978
Beskrivning
Concomitant agent
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
i.e: severe acute coronary heart disease, severe hypertension
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1301624
Beskrivning
Pregnancy or breastfeeding,childbearing potential
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
- UMLS CUI [3]
- C3831118
Beskrivning
Contraceptive measures
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0700589
Beskrivning
Informed consent
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2]
- C0439801
- UMLS CUI [3]
- C0009488
Beskrivning
Compliance behavior
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1321605
- UMLS CUI [2]
- C0439801
- UMLS CUI [3]
- C0009488
Beskrivning
i.e :co-workers of the sponsor or the clinical research centre, family members,...
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2347796
- UMLS CUI [1,2]
- C3244310
Beskrivning
Medical History and documentation of first Dose of trial substance
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Date of informed consent
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Patient Identification
Datatyp
integer
Alias
- UMLS CUI [1]
- C1269815
Beskrivning
Birth date
Datatyp
date
Måttenheter
- DD.MM.YYYY
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Gender
Datatyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Ethnicity
Datatyp
text
Alias
- UMLS CUI [1]
- C0015031
Beskrivning
Ethnicity
Datatyp
text
Alias
- UMLS CUI [1]
- C0015031
Beskrivning
not using safe contraception will result in exclusion from the trial
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0700589
Beskrivning
Pregnancy test
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0032976
Beskrivning
Date of pregnancy test
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beskrivning
Pregnancy test
Datatyp
text
Alias
- UMLS CUI [1]
- C0032976
Beskrivning
Blood Pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beskrivning
Height
Datatyp
integer
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Otorhinolaryngologic examination
Datatyp
text
Alias
- UMLS CUI [1]
- C0545486
Beskrivning
Otorhinolaryngologic examination
Datatyp
text
Alias
- UMLS CUI [1]
- C0545486
Beskrivning
Otorhinolaryngologic examination
Datatyp
text
Alias
- UMLS CUI [1]
- C0545486
Beskrivning
Allergologic medical history
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0262926
Beskrivning
Allergologic medical history
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0262926
Beskrivning
Allergologic medical history
Datatyp
text
Alias
- UMLS CUI [1]
- C0262926
Beskrivning
Rhinitis
Datatyp
text
Alias
- UMLS CUI [1]
- C0035455
Beskrivning
Rhinitis
Datatyp
text
Alias
- UMLS CUI [1]
- C0035455
Beskrivning
Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Allergic Rhinoconjunctivitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0861154
Beskrivning
Allergic rhinoconjunctivitis
Datatyp
date
Alias
- UMLS CUI [1]
- C0861154
Beskrivning
Allergic asthma
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0155877
Beskrivning
Allergic Asthma
Datatyp
date
Alias
- UMLS CUI [1]
- C0155877
Beskrivning
Allergic asthma
Datatyp
text
Alias
- UMLS CUI [1]
- C0155877
Beskrivning
Allergic asthma
Datatyp
text
Alias
- UMLS CUI [1]
- C0155877
Beskrivning
Antiallergic drugs
Datatyp
text
Alias
- UMLS CUI [1]
- C0282555
Beskrivning
retrospective assessment
Datatyp
text
Alias
- UMLS CUI [1]
- C1514923
- UMLS CUI [2]
- C0220825
Beskrivning
Comorbidities
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0009488
Beskrivning
Comorbidities
Datatyp
text
Alias
- UMLS CUI [1]
- C0009488
Beskrivning
Comorbidities
Datatyp
text
Alias
- UMLS CUI [1]
- C0009488
Beskrivning
Concomitant agent
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
contraindicated drugs include: antihistamins,decongestives (oral and nasal drops),steroids,any drug treatment to nose or eyes,asthma treatment other than inhalative beta-2-antagonists,Antileukotriene,beta-antagonists even if applied locally,ACE inhibitor drugs,Anti-IgE Antibodies,Tranquilizer,psychotropic drugs
Datatyp
text
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
Concomitant Agent
Datatyp
text
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
physical examination
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
Cardiovascular system
Datatyp
text
Alias
- UMLS CUI [1]
- C0007226
Beskrivning
Physical examination
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
Respiratory system
Datatyp
text
Alias
- UMLS CUI [1]
- C0035237
Beskrivning
Physical examination
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
Gastrointestinal system
Datatyp
text
Alias
- UMLS CUI [1]
- C0012240
Beskrivning
Physical examination
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
eyes
Datatyp
text
Alias
- UMLS CUI [1]
- C0015392
Beskrivning
Physical examination
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
Nose
Datatyp
text
Alias
- UMLS CUI [1]
- C0028429
Beskrivning
Physical examination
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
Ears
Datatyp
text
Alias
- UMLS CUI [1]
- C0013443
Beskrivning
Physical examination
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
Throat
Datatyp
text
Alias
- UMLS CUI [1]
- C0031354
Beskrivning
Physical examination
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
Endocrine system
Datatyp
text
Alias
- UMLS CUI [1]
- C0014130
Beskrivning
Physical examination
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
Musculoskeletal system
Datatyp
text
Alias
- UMLS CUI [1]
- C0026860
Beskrivning
Physical examination
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
central nervous system
Datatyp
text
Alias
- UMLS CUI [1]
- C3714787
Beskrivning
Physical examination
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
genitourinary tract
Datatyp
text
Alias
- UMLS CUI [1]
- C0042066
Beskrivning
Physical examination
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
lymphatic system
Datatyp
text
Alias
- UMLS CUI [1]
- C0024235
Beskrivning
Physical examination
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
Similar models
Case report form Visit 1
- StudyEvent: ODM
C0079399 (UMLS CUI [2])
C0861154 (UMLS CUI [2])
C3890583 (UMLS CUI [2])
C3714514 (UMLS CUI [2])
C0006267 (UMLS CUI [2])
C0020592 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
C3244310 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0220825 (UMLS CUI [2])