ID
13067
Beschrijving
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
Trefwoorden
Versies (1)
- 14-01-16 14-01-16 -
Geüploaded op
14 januari 2016
DOI
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Licentie
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
Beschrijving
Exclusion criteria
Beschrijving
Study subject participation status
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschrijving
hyposensitization
Datatype
boolean
Alias
- UMLS CUI [1]
- C0178702
Beschrijving
perennial rhinitis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0035457
Beschrijving
Asthma
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004096
Beschrijving
Inflammation or Infection
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021368
- UMLS CUI [2]
- C3714514
Beschrijving
Emphysema or bronchiectasis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0034067
- UMLS CUI [2]
- C0006267
Beschrijving
Tuberculosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0041296
Beschrijving
Autoimmune diseases
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004364
Beschrijving
Chronic inflammatory diseases
Datatype
boolean
Alias
- UMLS CUI [1]
- C1290886
Beschrijving
Malignancies
Datatype
boolean
Alias
- UMLS CUI [1]
- C0006826
Beschrijving
Substance use disorder
Datatype
boolean
Alias
- UMLS CUI [1]
- C0038586
Beschrijving
psychotropic drugs or tranquilizer
Datatype
boolean
Alias
- UMLS CUI [1]
- C0033978
- UMLS CUI [2]
- C0020592
Beschrijving
Anti-IgE Antibodies
Datatype
boolean
Alias
- UMLS CUI [1]
- C0051978
Beschrijving
Concomitant agent
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
i.e: severe acute coronary heart disease, severe hypertension
Datatype
boolean
Alias
- UMLS CUI [1]
- C1301624
Beschrijving
Pregnancy or breastfeeding,childbearing potential
Datatype
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
- UMLS CUI [3]
- C3831118
Beschrijving
Contraceptive measures
Datatype
boolean
Alias
- UMLS CUI [1]
- C0700589
Beschrijving
Informed consent
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2]
- C0439801
- UMLS CUI [3]
- C0009488
Beschrijving
Compliance behavior
Datatype
boolean
Alias
- UMLS CUI [1]
- C1321605
- UMLS CUI [2]
- C0439801
- UMLS CUI [3]
- C0009488
Beschrijving
i.e :co-workers of the sponsor or the clinical research centre, family members,...
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2347796
- UMLS CUI [1,2]
- C3244310
Beschrijving
Medical History and documentation of first Dose of trial substance
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Date of informed consent
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Patient Identification
Datatype
integer
Alias
- UMLS CUI [1]
- C1269815
Beschrijving
Birth date
Datatype
date
Maateenheden
- DD.MM.YYYY
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Gender
Datatype
integer
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Ethnicity
Datatype
text
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
Ethnicity
Datatype
text
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
not using safe contraception will result in exclusion from the trial
Datatype
boolean
Alias
- UMLS CUI [1]
- C0700589
Beschrijving
Pregnancy test
Datatype
boolean
Alias
- UMLS CUI [1]
- C0032976
Beschrijving
Date of pregnancy test
Datatype
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beschrijving
Pregnancy test
Datatype
text
Alias
- UMLS CUI [1]
- C0032976
Beschrijving
Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschrijving
Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Otorhinolaryngologic examination
Datatype
text
Alias
- UMLS CUI [1]
- C0545486
Beschrijving
Otorhinolaryngologic examination
Datatype
text
Alias
- UMLS CUI [1]
- C0545486
Beschrijving
Otorhinolaryngologic examination
Datatype
text
Alias
- UMLS CUI [1]
- C0545486
Beschrijving
Allergologic medical history
Datatype
boolean
Alias
- UMLS CUI [1]
- C0262926
Beschrijving
Allergologic medical history
Datatype
boolean
Alias
- UMLS CUI [1]
- C0262926
Beschrijving
Allergologic medical history
Datatype
text
Alias
- UMLS CUI [1]
- C0262926
Beschrijving
Rhinitis
Datatype
text
Alias
- UMLS CUI [1]
- C0035455
Beschrijving
Rhinitis
Datatype
text
Alias
- UMLS CUI [1]
- C0035455
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Allergic Rhinoconjunctivitis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0861154
Beschrijving
Allergic rhinoconjunctivitis
Datatype
date
Alias
- UMLS CUI [1]
- C0861154
Beschrijving
Allergic asthma
Datatype
boolean
Alias
- UMLS CUI [1]
- C0155877
Beschrijving
Allergic Asthma
Datatype
date
Alias
- UMLS CUI [1]
- C0155877
Beschrijving
Allergic asthma
Datatype
text
Alias
- UMLS CUI [1]
- C0155877
Beschrijving
Allergic asthma
Datatype
text
Alias
- UMLS CUI [1]
- C0155877
Beschrijving
Antiallergic drugs
Datatype
text
Alias
- UMLS CUI [1]
- C0282555
Beschrijving
retrospective assessment
Datatype
text
Alias
- UMLS CUI [1]
- C1514923
- UMLS CUI [2]
- C0220825
Beschrijving
Comorbidities
Datatype
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschrijving
Comorbidities
Datatype
text
Alias
- UMLS CUI [1]
- C0009488
Beschrijving
Comorbidities
Datatype
text
Alias
- UMLS CUI [1]
- C0009488
Beschrijving
Concomitant agent
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Concomitant Agent
Datatype
text
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
physical examination
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
Cardiovascular system
Datatype
text
Alias
- UMLS CUI [1]
- C0007226
Beschrijving
Physical examination
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
Respiratory system
Datatype
text
Alias
- UMLS CUI [1]
- C0035237
Beschrijving
Physical examination
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
Gastrointestinal system
Datatype
text
Alias
- UMLS CUI [1]
- C0012240
Beschrijving
Physical examination
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
eyes
Datatype
text
Alias
- UMLS CUI [1]
- C0015392
Beschrijving
Physical examination
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
Nose
Datatype
text
Alias
- UMLS CUI [1]
- C0028429
Beschrijving
Physical examination
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
Ears
Datatype
text
Alias
- UMLS CUI [1]
- C0013443
Beschrijving
Physical examination
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
Throat
Datatype
text
Alias
- UMLS CUI [1]
- C0031354
Beschrijving
Physical examination
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
Endocrine system
Datatype
text
Alias
- UMLS CUI [1]
- C0014130
Beschrijving
Physical examination
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
Musculoskeletal system
Datatype
text
Alias
- UMLS CUI [1]
- C0026860
Beschrijving
Physical examination
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
central nervous system
Datatype
text
Alias
- UMLS CUI [1]
- C3714787
Beschrijving
Physical examination
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
genitourinary tract
Datatype
text
Alias
- UMLS CUI [1]
- C0042066
Beschrijving
Physical examination
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
lymphatic system
Datatype
text
Alias
- UMLS CUI [1]
- C0024235
Beschrijving
Physical examination
Datatype
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])