ID

13250

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. 1/26/16 1/26/16 -
Uploaded on

January 26, 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 overall appraisal of treatment

English

Case Report Form: overall appraisal of treatment

1 forms  
Appraisal by Investigator
Description

Appraisal by Investigator

Effectiveness of treatment in comparison to last years pollen season
Description

Please note your professional opinion regarding treatment success. Please take into consideration the severity of symptoms of last years pollen season as well as other medical conditions of your patient

Data type

text

Alias
UMLS CUI [1]
C0087113
General tolerance of trial substance
Description

Tolerance

Data type

text

Alias
UMLS CUI [1]
C0231197
Appraisal by patient
Description

Appraisal by patient

Please rate your satisfaction with the resulting desensitization by the investigational agent
Description

Satisfaction with treatment

Data type

text

Alias
UMLS CUI [1,1]
C0242428
UMLS CUI [1,2]
C0949266
Would you recommend this treatment of specific desensitization to other patients?
Description

Recommendation

Data type

text

Alias
UMLS CUI [1]
C0034866
Date and Signature
Description

Date and Signature

Study completion form has been filled in
Description

Study completion form

Data type

boolean

Alias
UMLS CUI [1,1]
C1547674
UMLS CUI [1,2]
C0008976
Date of completion of this form
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
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Similar models

Case Report Form: overall appraisal of treatment

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Appraisal by Investigator
Item
Effectiveness of treatment in comparison to last years pollen season
text
C0087113 (UMLS CUI [1])
Efficacy of treatment
Code List
Effectiveness of treatment in comparison to last years pollen season
CL Item
deteriorated condition (0)
CL Item
no change in condition (1)
CL Item
little to moderate improvement (2)
CL Item
distinct to very pronounced improvement (3)
Item
General tolerance of trial substance
text
C0231197 (UMLS CUI [1])
Tolerance
Code List
General tolerance of trial substance
CL Item
poor (0)
CL Item
moderate (1)
CL Item
good (2)
CL Item
very good (3)
Item Group
Appraisal by patient
Item
Please rate your satisfaction with the resulting desensitization by the investigational agent
text
C0242428 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
Satisfaction with treatment
Code List
Please rate your satisfaction with the resulting desensitization by the investigational agent
CL Item
not at all satisfied (0)
CL Item
less satisfied (1)
CL Item
satisfied (2)
CL Item
very satisfied (3)
Item
Would you recommend this treatment of specific desensitization to other patients?
text
C0034866 (UMLS CUI [1])
Recommendation
Code List
Would you recommend this treatment of specific desensitization to other patients?
CL Item
I certainly wouldn´t recommend this treatment (0)
CL Item
I probably wouldn´t recommend this treatment (1)
CL Item
I probably would recommend this treatment (2)
CL Item
I certainly would recommend this treatment (3)
Item Group
Date and Signature
Study completion form
Item
Study completion form has been filled in
boolean
C1547674 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Date
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
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