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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 -
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14 januari 2016
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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
Similar models
Case report form Visit 1
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Age and gender
Item
Male or female between 18 and 75 years of age
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0079399 (UMLS CUI [2])
Allergic rhinitis or rhinoconjunctivitis
Item
Allergic rhinitis or rhinoconjunctivitis with or without controlled seasonal asthma due to allergen-exposure
boolean
C2607914 (UMLS CUI [1])
C0861154 (UMLS CUI [2])
C0861154 (UMLS CUI [2])
Sensitization
Item
Sensitization to grass and/or rye pollen
boolean
C3662483 (UMLS CUI [1])
Seasonal Symptoms
Item
The majority of symptoms is experienced during grass pollen season
boolean
C2039344 (UMLS CUI [1])
positive Scratch Test
Item
Positive scratch test for grass pollen with minimum diameter of rash 3mm
boolean
C0857598 (UMLS CUI [1])
Item
Planned treatment for allergies and/or asthma with at least one of the following substances
text
C1262684 (UMLS CUI [1])
Code List
Planned treatment for allergies and/or asthma with at least one of the following substances
CL Item
local cromoglycate (eye,nose) (1)
CL Item
oral antihistamine (2)
CL Item
nasal steroid (3)
CL Item
oral leukotriene antagonist (4)
Allergy symptom score
Item
total symptom score of equal to or higher than 8 during previous pollen season
boolean
C3533163 (UMLS CUI [1])
Compliance behavior using a patient diary
Item
Patient is willing and able to keep track of symptoms and antiallergic medication with a patient diary
boolean
C1321605 (UMLS CUI [1])
C3890583 (UMLS CUI [2])
C3890583 (UMLS CUI [2])
Informed consent
Item
Signed informed consent
boolean
C0021430 (UMLS CUI [1])
Normal blood chemistry
Item
All laboratory results are within normal range or to be considered not relevant
boolean
C0438257 (UMLS CUI [1])
Study subject participation status
Item
Participation in any other clinical trial at the same time
boolean
C2348568 (UMLS CUI [1])
hyposensitization
Item
Hyposensitization with grass or rye pollen extract within 3 years prior to enrollment
boolean
C0178702 (UMLS CUI [1])
perennial rhinitis
Item
Predominantly perennial allergic rhinitis
boolean
C0035457 (UMLS CUI [1])
Asthma
Item
Poorly or not controlled Asthma (GINA Guidelines 2007)
boolean
C0004096 (UMLS CUI [1])
Inflammation or Infection
Item
Inflammation or Infection of targeted organs
boolean
C0021368 (UMLS CUI [1])
C3714514 (UMLS CUI [2])
C3714514 (UMLS CUI [2])
Emphysema or bronchiectasis
Item
Irreversible secondary changes to the targeted organ like emphysema or bronchiectasis (FEV < 70 percent of predicted value)
boolean
C0034067 (UMLS CUI [1])
C0006267 (UMLS CUI [2])
C0006267 (UMLS CUI [2])
Tuberculosis
Item
Active tuberculosis
boolean
C0041296 (UMLS CUI [1])
Autoimmune diseases
Item
Autoimmune diseases
boolean
C0004364 (UMLS CUI [1])
Chronic inflammatory diseases
Item
Severe chronic inflammatory diseases
boolean
C1290886 (UMLS CUI [1])
Malignancies
Item
Malignancies
boolean
C0006826 (UMLS CUI [1])
Substance use disorder
Item
Alcohol abuse
boolean
C0038586 (UMLS CUI [1])
psychotropic drugs or tranquilizer
Item
Prior or continuing treatment with psychotropic drugs or tranquilizer
boolean
C0033978 (UMLS CUI [1])
C0020592 (UMLS CUI [2])
C0020592 (UMLS CUI [2])
Anti-IgE Antibodies
Item
Prior or continuing treatment with Anti-IgE Antibodies
boolean
C0051978 (UMLS CUI [1])
Concomitant agent
Item
Treatment with adrenergic beta receptor antagonists (including locally applied eye drops) or other contraindicated drugs
boolean
C2347852 (UMLS CUI [1])
Contraindication
Item
Any contraindication to the use of Adrenaline
boolean
C1301624 (UMLS CUI [1])
Pregnancy or breastfeeding,childbearing potential
Item
Women of childbearing potential, pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
Contraceptive measures
Item
Female of childbearing potential, not using safe contraceptive measures
boolean
C0700589 (UMLS CUI [1])
Informed consent
Item
Ability to understand directions or protocol limited due to comorbidity or language barrier
boolean
C0021430 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
Compliance behavior
Item
Suspected poor compliance or other contraindications to enrollment to the discretion of the investigator
boolean
C1321605 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
Dependency from investigator or sponsor
Item
Dependency from the sponsor or the clinical investigator
boolean
C2347796 (UMLS CUI [1,1])
C3244310 (UMLS CUI [1,2])
C3244310 (UMLS CUI [1,2])
Item Group
Medical History and documentation of first Dose of trial substance
Date
Item
Date of visit 1
date
C0011008 (UMLS CUI [1])
Date of informed consent
Item
Date of informed consent
date
C0011008 (UMLS CUI [1])
Patient Identification
Item
Please give Patient ID composed of Study site Nr and Patient Nr
integer
C1269815 (UMLS CUI [1])
Birth date
Item
Patient date of birth
date
C0421451 (UMLS CUI [1])
CL Item
male (1)
CL Item
female (2)
CL Item
caucasian (1)
CL Item
asian (2)
CL Item
negroid (3)
CL Item
other (4)
Ethnicity
Item
Please specify other ethnicity
text
C0015031 (UMLS CUI [1])
Contraceptive measures
Item
Female of childbearing potential, using safe contraceptive measures
boolean
C0700589 (UMLS CUI [1])
Pregnancy test
Item
Was a pregnancy test performed?
boolean
C0032976 (UMLS CUI [1])
Date of pregnancy test
Item
Please specify the date of the pregnancy test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
positive-> exclusion from trial (1)
CL Item
negative->safe contraception throughout the trial (2)
Blood Pressure
Item
Blood pressure (BP)
integer
C0005823 (UMLS CUI [1])
Height
Item
Body height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
CL Item
none (0)
CL Item
little (1)
CL Item
severe (2)
CL Item
none (0)
CL Item
clear fluid (1)
CL Item
congested/mucous (2)
CL Item
none (0)
CL Item
little (1)
CL Item
severe (2)
Allergologic medical history
Item
Sensitization against grass pollen
boolean
C0262926 (UMLS CUI [1])
Allergologic medical history
Item
Sensitization against rye pollen
boolean
C0262926 (UMLS CUI [1])
Allergologic medical history
Item
Sensitization against other allergen,please specify
text
C0262926 (UMLS CUI [1])
CL Item
yes (1)
CL Item
No-> exclusion from trial (2)
CL Item
seasonal (1)
CL Item
perennial-> exclusion from trial (2)
Start Date
Item
Year Rhinitis occurred for the first time
date
C0011008 (UMLS CUI [1])
Allergic Rhinoconjunctivitis
Item
Clinical symptoms of rhinoconjunctivitis present?
boolean
C0861154 (UMLS CUI [1])
Allergic rhinoconjunctivitis
Item
Year rhinoconjunctivitis occurred for the first time
date
C0861154 (UMLS CUI [1])
Allergic asthma
Item
Has the patient been diagnosed with allergic asthma?
boolean
C0155877 (UMLS CUI [1])
Allergic Asthma
Item
Please state the year allergic asthma has been diagnosed
date
C0155877 (UMLS CUI [1])
CL Item
seasonal (1)
CL Item
perennial -> exclusion from trial (2)
CL Item
controlled (1)
CL Item
partially controlled ->exclusion from trial (2)
CL Item
uncontrolled -> exclusion from trial (3)
CL Item
local cromoglycat (1)
CL Item
oral antihistamine (2)
CL Item
nasal steroid (3)
retrospective assessment
Item
Please specify prior illnesses,vaccinations and antibiotic treatment of the past 10 years
text
C1514923 (UMLS CUI [1])
C0220825 (UMLS CUI [2])
C0220825 (UMLS CUI [2])
Comorbidities
Item
Are there any comorbidities?
boolean
C0009488 (UMLS CUI [1])
CL Item
active tuberculosis -> exclusion (1)
CL Item
autoimmune diseases -> exclusion (2)
CL Item
severe chronic inflammatory diseases -> exclusion (3)
CL Item
malignancies -> exclusion (4)
CL Item
irreversible secondary changes to the targeted organ -> exclusion (5)
CL Item
severe hypertension -> exclusion (6)
CL Item
other (7)
Comorbidities
Item
Please specify other comorbidities
text
C0009488 (UMLS CUI [1])
Concomitant agent
Item
Does the patient use any other medication?
boolean
C2347852 (UMLS CUI [1])
Item
Does the patient use any of the above mentioned medications?
text
C2347852 (UMLS CUI [1])
CL Item
yes -> exclusion (1)
CL Item
no (2)
Concomitant Agent
Item
Please specify any other concomitant agent
text
C2347852 (UMLS CUI [1])
CL Item
normal (1)
CL Item
abnormal (2)
Cardiovascular system
Item
Please specify findings during examination of the cardiovascular system
text
C0007226 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
Respiratory system
Item
Please specify findings during examination of the respiratory system
text
C0035237 (UMLS CUI [1])
CL Item
normal (1)
CL Item
abnormal (2)
Gastrointestinal system
Item
Please specify findings during examination of the gastrointestinal system
text
C0012240 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
eyes
Item
Please specify findings during examination of the eyes
text
C0015392 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
Nose
Item
Please specify findings during examination of the nose
text
C0028429 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
Ears
Item
Please specify findings during examination of the ears
text
C0013443 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
Throat
Item
Please specify findings during examination of the throat
text
C0031354 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
Endocrine system
Item
Please specify findings during testing of the endocrine system
text
C0014130 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
Musculoskeletal system
Item
Please specify findings during examination of the musculoskeletal system
text
C0026860 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
central nervous system
Item
Please specify findings during the examination of the central nervous system
text
C3714787 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
genitourinary tract
Item
Please specify findings during examination of the genitourinary tract
text
C0042066 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
lymphatic system
Item
Please specify findings during examination of the lymphatic system
text
C0024235 (UMLS CUI [1])
Physical examination
Item
Please specify any other finding during the physical examination
text
C0031809 (UMLS CUI [1])