Information:
Fel:
ID
13225
Beskrivning
Placebo controlled,double blind and randomized parallel group trial to verify effectivity and tolerability of moxaverine p.o. in patients with central nervous vertigo. Sponsor: URSAPHARM Industriestrasse 66129 Saarbrücken Phone 06805-9292-0 Fax 06805- 929288 Head of clinical trial: Univ.-Prof.Dr.med. Ralph Mösges Medical Faculty, University of Cologne Phone 0221-4783456 Fax 0221-4783465
Nyckelord
Versioner (3)
- 2016-01-11 2016-01-11 -
- 2016-01-13 2016-01-13 -
- 2016-01-25 2016-01-25 - Julian Varghese
Uppladdad den
25 januari 2016
DOI
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Licens
Creative Commons BY-NC 3.0
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Moxaverine 200mg p.o. in patients with central nervous vertigo
Similar models
Case report form Visit 1
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Patient number
Item
Patient number
integer
C1830427 (UMLS CUI [1])
Study site
Item
Study site number
integer
C2825164 (UMLS CUI [1])
Date
Item
Assessment Date
date
C0011008 (UMLS CUI [1])
informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Date of informed consent
Item
Date of informed consent
date
C0011008 (UMLS CUI [1])
Patient Initials
Item
Patient Initials: first three characters of given and last name
text
C2986440 (UMLS CUI [1])
Patient age
Item
Patient age
integer
C0001779 (UMLS CUI [1])
CL Item
Male (m)
CL Item
Female (f)
Height
Item
Body height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Occupation
Item
What is your current occupation?
text
C0028811 (UMLS CUI [1])
CL Item
caucasian (1)
CL Item
negroid (2)
CL Item
asian (3)
CL Item
other (4)
Item
Are there any of the following neurological conditions (as well in patient medical history)
text
C0027765 (UMLS CUI [1])
Code List
Are there any of the following neurological conditions (as well in patient medical history)
CL Item
apoplexy (1)
CL Item
multiple sclerosis (2)
CL Item
M. Parkinson (3)
CL Item
cerebellar vertigo (4)
CL Item
polyneuropathy (5)
CL Item
traumatic brain injury (6)
CL Item
cerebellar infarction (7)
Item
Are there any of the following ENT-conditions (as well in patient medical history)
text
C0029896 (UMLS CUI [1])
Code List
Are there any of the following ENT-conditions (as well in patient medical history)
CL Item
sudden hearing loss with asymmetrical hearing impairment > 20db (1)
CL Item
vestibular vertigo(caloric vestibular testing at 44°C >20 percent) (2)
central nervous vertigo
Item
Has the diagnose of central nervous vertigo been confirmed?
boolean
C0155503 (UMLS CUI [1])
Inclusion
Item
Patient will be included into this trial
boolean
C1512693 (UMLS CUI [1])
date
Item
Signature Date
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1550483 (UMLS CUI [1])
central nervous vertigo
Item
Patient has central nervous vertigo
boolean
Patient age and gender
Item
Patient, male or female, age between 18-75
boolean
C0150831 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Informed consent
Item
Patient hast given written informed consent
boolean
C0021430 (UMLS CUI [1])
Compliance behavior
Item
Patient is willing and able to comply to study protocol
boolean
C1321605 (UMLS CUI [1])
Inclusion criteria
Item
Patient does not meet all required inclusion criteria
boolean
C1512693 (UMLS CUI [1])
Concomitant agent
Item
Patient is currently using medication that is not allowed during the trial
boolean
C2347852 (UMLS CUI [1])
Compliance behavior
Item
Patient cannot be tested on tetrax platform because of comorbidities
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Hypersensitivity
Item
Hypersensitivity to Moxaverine
boolean
C0020517 (UMLS CUI [1,1])
C0129044 (UMLS CUI [1,2])
C0129044 (UMLS CUI [1,2])
vestibular or cerebellar vertigo
Item
Patient has vestibular or cerebellar vertigo
boolean
C0151222 (UMLS CUI [1])
C0234756 (UMLS CUI [2])
C0234756 (UMLS CUI [2])
asymmetric hearing impairment
Item
Patient has asymmetric hearing impairment (> 20 db)
boolean
C1997086 (UMLS CUI [1])
vestibular evaluation with caloric testing
Item
Patient shows side difference in vestibular evaluation with caloric testing
boolean
C2189441 (UMLS CUI [1])
Comorbidity
Item
Patient is diagnosed with multiple sclerosis,parkinsons disease,polyneuropathy, malignancies or HIV
boolean
C0009488 (UMLS CUI [1])
Patient medical history
Item
Patient has a history of myocardial infarction or apoplexy
boolean
C0262926 (UMLS CUI [1])
Comorbidity
Item
Patient has a condition that could influence gastrointestinal absorption of the tested substance
boolean
C0009488 (UMLS CUI [1])
Compliance behavior
Item
Patient is suspected of poor compliance behavior
boolean
C1321605 (UMLS CUI [1])
Study Subject Participation Status
Item
Subject Participation Status in Clinical Study within last four weeks
boolean
C2348568 (UMLS CUI [1])
pregnancy or breastfeeding, contraceptive methods
Item
Women pregnant or breastfeeding or of childbearing potential not using adequate contraceptive methods
boolean
C0700589 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Substance use disorder
Item
Patients with a history of substance use disorder within one year prior to enrollment
boolean
C0038586 (UMLS CUI [1])
Informed consent
Item
Informed consent limited due to comorbidity or language barrier
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Date
Item
Date of signature
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1550483 (UMLS CUI [1])
CL Item
normal (1)
CL Item
findings (2)
Otoscopy
Item
Please specify findings of Otoscopy
text
C0419361 (UMLS CUI [1])
CL Item
normal (1)
CL Item
findings (2)
Rinne test
Item
Please specify findings of Rinne test
text
C0278245 (UMLS CUI [1])
CL Item
normal (1)
CL Item
findings (2)
Webers test
Item
Please specify findings of Webers test
text
C0278247 (UMLS CUI [1])
Nystagmus testing with frenzel-lens eyeglasses
Item
Nystagmus testing with frenzel-lens eyeglasses
boolean
C2721529 (UMLS CUI [1])
CL Item
horizontal (1)
CL Item
vertical (2)
CL Item
rotating (3)
Item
Amplitude of eye movement with frenzel-lens eyeglasses
text
C0028738 (UMLS CUI [1,1])
C2346753 (UMLS CUI [1,2])
C2346753 (UMLS CUI [1,2])
CL Item
small (1)
CL Item
medium (2)
CL Item
heavy (3)
Item
Frequency of eye movement with frenzel lens eyeglasses
text
C0028738 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
CL Item
little (1)
CL Item
medium (2)
CL Item
high (3)
CL Item
little (1)
CL Item
distinctly (2)
CL Item
severe (3)
Computerized dynamic posturography procedure
Item
Any significant findings during computerized dynamic posturography procedure
boolean
C0519978 (UMLS CUI [1])
Computerized dynamic posturography procedure
Item
Please specify findings during computerized dynamic posturography procedure
text
C0519978 (UMLS CUI [1])
Questionnaire
Item
DHI-Questionnaire given to patient
boolean
C0034394 (UMLS CUI [1])
Patient identification card
Item
Patient identification card handed to patient
boolean
C0030692 (UMLS CUI [1])
Medication dispensed
Item
correct amount of trial substance handed to patient
boolean
C0947323 (UMLS CUI [1])
Patient questions
Item
Any questions the patient might have have been answered.
boolean
C0547398 (UMLS CUI [1])
Date
Item
Signature Date
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
Comorbidities
Item
Are there any comorbidities?
boolean
C0009488 (UMLS CUI [1])
Comorbidities
Item
Please specify comorbidities by ICD-Code
text
C0009488 (UMLS CUI [1])
Concomitant agent
Item
Does the patient use any other medication?
boolean
C2347852 (UMLS CUI [1])
Concomitant Agent
Item
Please specify medication name,dose,start and end date of therapy
text
C2347852 (UMLS CUI [1])
additional comments
Item
additional comments
text
C1830770 (UMLS CUI [1])
Date
Item
Signature Date
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])