ID
13067
Beschreibung
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
Stichworte
Versionen (1)
- 14.01.16 14.01.16 -
Hochgeladen am
14. Januar 2016
DOI
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Lizenz
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
Beschreibung
Exclusion criteria
Beschreibung
Study subject participation status
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschreibung
hyposensitization
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0178702
Beschreibung
perennial rhinitis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0035457
Beschreibung
Asthma
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004096
Beschreibung
Inflammation or Infection
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021368
- UMLS CUI [2]
- C3714514
Beschreibung
Emphysema or bronchiectasis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0034067
- UMLS CUI [2]
- C0006267
Beschreibung
Tuberculosis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0041296
Beschreibung
Autoimmune diseases
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004364
Beschreibung
Chronic inflammatory diseases
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1290886
Beschreibung
Malignancies
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0006826
Beschreibung
Substance use disorder
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0038586
Beschreibung
psychotropic drugs or tranquilizer
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0033978
- UMLS CUI [2]
- C0020592
Beschreibung
Anti-IgE Antibodies
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0051978
Beschreibung
Concomitant agent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
i.e: severe acute coronary heart disease, severe hypertension
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1301624
Beschreibung
Pregnancy or breastfeeding,childbearing potential
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
- UMLS CUI [3]
- C3831118
Beschreibung
Contraceptive measures
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0700589
Beschreibung
Informed consent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2]
- C0439801
- UMLS CUI [3]
- C0009488
Beschreibung
Compliance behavior
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1321605
- UMLS CUI [2]
- C0439801
- UMLS CUI [3]
- C0009488
Beschreibung
i.e :co-workers of the sponsor or the clinical research centre, family members,...
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2347796
- UMLS CUI [1,2]
- C3244310
Beschreibung
Medical History and documentation of first Dose of trial substance
Beschreibung
Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
Date of informed consent
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
Patient Identification
Datentyp
integer
Alias
- UMLS CUI [1]
- C1269815
Beschreibung
Birth date
Datentyp
date
Maßeinheiten
- DD.MM.YYYY
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Gender
Datentyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Ethnicity
Datentyp
text
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
Ethnicity
Datentyp
text
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
not using safe contraception will result in exclusion from the trial
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0700589
Beschreibung
Pregnancy test
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0032976
Beschreibung
Date of pregnancy test
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beschreibung
Pregnancy test
Datentyp
text
Alias
- UMLS CUI [1]
- C0032976
Beschreibung
Blood Pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschreibung
Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Heart rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Otorhinolaryngologic examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0545486
Beschreibung
Otorhinolaryngologic examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0545486
Beschreibung
Otorhinolaryngologic examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0545486
Beschreibung
Allergologic medical history
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0262926
Beschreibung
Allergologic medical history
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0262926
Beschreibung
Allergologic medical history
Datentyp
text
Alias
- UMLS CUI [1]
- C0262926
Beschreibung
Rhinitis
Datentyp
text
Alias
- UMLS CUI [1]
- C0035455
Beschreibung
Rhinitis
Datentyp
text
Alias
- UMLS CUI [1]
- C0035455
Beschreibung
Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
Allergic Rhinoconjunctivitis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0861154
Beschreibung
Allergic rhinoconjunctivitis
Datentyp
date
Alias
- UMLS CUI [1]
- C0861154
Beschreibung
Allergic asthma
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0155877
Beschreibung
Allergic Asthma
Datentyp
date
Alias
- UMLS CUI [1]
- C0155877
Beschreibung
Allergic asthma
Datentyp
text
Alias
- UMLS CUI [1]
- C0155877
Beschreibung
Allergic asthma
Datentyp
text
Alias
- UMLS CUI [1]
- C0155877
Beschreibung
Antiallergic drugs
Datentyp
text
Alias
- UMLS CUI [1]
- C0282555
Beschreibung
retrospective assessment
Datentyp
text
Alias
- UMLS CUI [1]
- C1514923
- UMLS CUI [2]
- C0220825
Beschreibung
Comorbidities
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschreibung
Comorbidities
Datentyp
text
Alias
- UMLS CUI [1]
- C0009488
Beschreibung
Comorbidities
Datentyp
text
Alias
- UMLS CUI [1]
- C0009488
Beschreibung
Concomitant agent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
Concomitant Agent
Datentyp
text
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
physical examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
Cardiovascular system
Datentyp
text
Alias
- UMLS CUI [1]
- C0007226
Beschreibung
Physical examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
Respiratory system
Datentyp
text
Alias
- UMLS CUI [1]
- C0035237
Beschreibung
Physical examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
Gastrointestinal system
Datentyp
text
Alias
- UMLS CUI [1]
- C0012240
Beschreibung
Physical examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
eyes
Datentyp
text
Alias
- UMLS CUI [1]
- C0015392
Beschreibung
Physical examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
Nose
Datentyp
text
Alias
- UMLS CUI [1]
- C0028429
Beschreibung
Physical examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
Ears
Datentyp
text
Alias
- UMLS CUI [1]
- C0013443
Beschreibung
Physical examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
Throat
Datentyp
text
Alias
- UMLS CUI [1]
- C0031354
Beschreibung
Physical examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
Endocrine system
Datentyp
text
Alias
- UMLS CUI [1]
- C0014130
Beschreibung
Physical examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
Musculoskeletal system
Datentyp
text
Alias
- UMLS CUI [1]
- C0026860
Beschreibung
Physical examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
central nervous system
Datentyp
text
Alias
- UMLS CUI [1]
- C3714787
Beschreibung
Physical examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
genitourinary tract
Datentyp
text
Alias
- UMLS CUI [1]
- C0042066
Beschreibung
Physical examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
lymphatic system
Datentyp
text
Alias
- UMLS CUI [1]
- C0024235
Beschreibung
Physical examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0031809
Ähnliche Modelle
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])