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