ID

13225

Description

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

Keywords

Versions (3)
  1. 1/11/16 1/11/16 -
  2. 1/13/16 1/13/16 -
  3. 1/25/16 1/25/16 - Julian Varghese
Uploaded on

January 25, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Moxaverine 200mg p.o. in patients with central nervous vertigo

English

Case report form Visit 1

1 forms  
Demographic Information
Description

Demographic Information

Patient number
Description

Patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Study site number
Description

Study site

Data type

integer

Alias
UMLS CUI [1]
C2825164
Assessment Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
signed informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Date of informed consent
Description

Date of informed consent

Data type

date

Alias
UMLS CUI [1]
C0011008
Patient Initials: first three characters of given and last name
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Patient age
Description

Patient age

Data type

integer

Alias
UMLS CUI [1]
C0001779
Patient Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Body height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
What is your current occupation?
Description

Occupation

Data type

text

Alias
UMLS CUI [1]
C0028811
Patient Ethnicity
Description

Ethnic Group

Data type

text

Alias
UMLS CUI [1]
C0015031
neurological preliminary assessment
Description

neurological preliminary assessment

Are there any of the following neurological conditions (as well in patient medical history)
Description

If any one of the following is answered with yes, the patient may not be included.

Data type

text

Alias
UMLS CUI [1]
C0027765
otorhinolaryngologic preliminary assessment
Description

otorhinolaryngologic preliminary assessment

Are there any of the following ENT-conditions (as well in patient medical history)
Description

If any one of the following is answered yes, the patient may not be included

Data type

text

Alias
UMLS CUI [1]
C0029896
Eligibility
Description

Eligibility

Has the diagnose of central nervous vertigo been confirmed?
Description

central nervous vertigo

Data type

boolean

Alias
UMLS CUI [1]
C0155503
Patient will be included into this trial
Description

Inclusion

Data type

boolean

Alias
UMLS CUI [1]
C1512693
Signature Date
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1550483
Inclusion criteria
Description

Inclusion criteria

Patient has central nervous vertigo
Description

central nervous vertigo

Data type

boolean

Patient, male or female, age between 18-75
Description

Patient age and gender

Data type

boolean

Alias
UMLS CUI [1]
C0150831
UMLS CUI [2]
C0001779
Patient hast given written informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Patient is willing and able to comply to study protocol
Description

Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion criteria
Description

Exclusion criteria

Patient does not meet all required inclusion criteria
Description

Inclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
Patient is currently using medication that is not allowed during the trial
Description

Concomitant agent

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Patient cannot be tested on tetrax platform because of comorbidities
Description

Compliance behavior

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
Hypersensitivity to Moxaverine
Description

Hypersensitivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0129044
Patient has vestibular or cerebellar vertigo
Description

vestibular or cerebellar vertigo

Data type

boolean

Alias
UMLS CUI [1]
C0151222
UMLS CUI [2]
C0234756
Patient has asymmetric hearing impairment (> 20 db)
Description

asymmetric hearing impairment

Data type

boolean

Alias
UMLS CUI [1]
C1997086
Patient shows side difference in vestibular evaluation with caloric testing
Description

vestibular evaluation with caloric testing

Data type

boolean

Alias
UMLS CUI [1]
C2189441
Patient is diagnosed with multiple sclerosis,parkinsons disease,polyneuropathy, malignancies or HIV
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
Patient has a history of myocardial infarction or apoplexy
Description

Patient medical history

Data type

boolean

Alias
UMLS CUI [1]
C0262926
Patient has a condition that could influence gastrointestinal absorption of the tested substance
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
Patient is suspected of poor compliance behavior
Description

Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Subject Participation Status in Clinical Study within last four weeks
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Women pregnant or breastfeeding or of childbearing potential not using adequate contraceptive methods
Description

pregnancy or breastfeeding, contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
Patients with a history of substance use disorder within one year prior to enrollment
Description

Substance use disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
Informed consent limited due to comorbidity or language barrier
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
Date of signature
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1550483
otorhinolaryngologic examination
Description

otorhinolaryngologic examination

Otoscopy
Description

Otoscopy

Data type

text

Alias
UMLS CUI [1]
C0419361
Please specify findings of Otoscopy
Description

Otoscopy

Data type

text

Alias
UMLS CUI [1]
C0419361
Rinne test
Description

Rinne test

Data type

text

Alias
UMLS CUI [1]
C0278245
Please specify findings of Rinne test
Description

Rinne test

Data type

text

Alias
UMLS CUI [1]
C0278245
Webers test
Description

Webers test

Data type

text

Alias
UMLS CUI [1]
C0278247
Please specify findings of Webers test
Description

Webers test

Data type

text

Alias
UMLS CUI [1]
C0278247
Nystagmus testing with frenzel-lens eyeglasses
Description

Nystagmus testing with frenzel-lens eyeglasses

Data type

boolean

Alias
UMLS CUI [1]
C2721529
Direction of eye movement with frenzel-lens eyeglasses
Description

Nystagmus testing with frenzel-lens eyeglasses

Data type

text

Alias
UMLS CUI [1]
C0339666
Amplitude of eye movement with frenzel-lens eyeglasses
Description

Nystagmus testing with frenzel-lens eyeglasses

Data type

text

Alias
UMLS CUI [1,1]
C0028738
UMLS CUI [1,2]
C2346753
Frequency of eye movement with frenzel lens eyeglasses
Description

Nystagmus testing with frenzel-lens eyeglasses

Data type

text

Alias
UMLS CUI [1,1]
C0028738
UMLS CUI [1,2]
C0439603
Dizziness with frenzel lens eyeglasses
Description

Nystagmus testing with frenzel-lens eyeglasses

Data type

text

Alias
UMLS CUI [1]
C0012833
Posturography
Description

Posturography

Any significant findings during computerized dynamic posturography procedure
Description

Computerized dynamic posturography procedure

Data type

boolean

Alias
UMLS CUI [1]
C0519978
Please specify findings during computerized dynamic posturography procedure
Description

Computerized dynamic posturography procedure report has to be enclosed

Data type

text

Alias
UMLS CUI [1]
C0519978
Tasks of investigator during this visit
Description

Tasks of investigator during this visit

DHI-Questionnaire given to patient
Description

Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C0034394
Patient identification card handed to patient
Description

Patient identification card

Data type

boolean

Alias
UMLS CUI [1]
C0030692
correct amount of trial substance handed to patient
Description

Medication dispensed

Data type

boolean

Alias
UMLS CUI [1]
C0947323
Any questions the patient might have have been answered.
Description

Patient questions

Data type

boolean

Alias
UMLS CUI [1]
C0547398
Signature Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
Comorbidities and concomitant Medication
Description

Comorbidities and concomitant Medication

Are there any comorbidities?
Description

Comorbidities

Data type

boolean

Alias
UMLS CUI [1]
C0009488
Please specify comorbidities by ICD-Code
Description

Comorbidities

Data type

text

Alias
UMLS CUI [1]
C0009488
Does the patient use any other medication?
Description

prohibited medication: -aminoglycoside antibiotics -vasoactive agents -stimulants to the central nervous system -tranquilizer -agents aiming at cell metabolism -antihistamines -Antiplatelet Agents -anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Please specify medication name,dose,start and end date of therapy
Description

Concomitant Agent

Data type

text

Alias
UMLS CUI [1]
C2347852
additional comments
Description

additional comments

Data type

text

Alias
UMLS CUI [1]
C1830770
Signature Date
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 Visit 1

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Demographic Information
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])
Item
Patient Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Patient Gender
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])
Item
Patient Ethnicity
text
C0015031 (UMLS CUI [1])
Ethnic Group
Code List
Patient Ethnicity
CL Item
caucasian (1)
CL Item
negroid (2)
CL Item
asian (3)
CL Item
other (4)
Item Group
neurological preliminary assessment
Item
Are there any of the following neurological conditions (as well in patient medical history)
text
C0027765 (UMLS CUI [1])
neurological conditions
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 Group
otorhinolaryngologic preliminary assessment
Item
Are there any of the following ENT-conditions (as well in patient medical history)
text
C0029896 (UMLS CUI [1])
Otorhinolaryngologic conditions
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)
Item Group
Eligibility
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])
Item Group
Inclusion criteria
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])
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])
Item Group
Exclusion criteria
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])
Hypersensitivity
Item
Hypersensitivity to Moxaverine
boolean
C0020517 (UMLS CUI [1,1])
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])
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])
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])
Date
Item
Date of signature
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1550483 (UMLS CUI [1])
Item Group
otorhinolaryngologic examination
Item
Otoscopy
text
C0419361 (UMLS CUI [1])
Otoscopy
Code List
Otoscopy
CL Item
normal (1)
CL Item
findings (2)
Otoscopy
Item
Please specify findings of Otoscopy
text
C0419361 (UMLS CUI [1])
Item
Rinne test
text
C0278245 (UMLS CUI [1])
Rinne test
Code List
Rinne test
CL Item
normal (1)
CL Item
findings (2)
Rinne test
Item
Please specify findings of Rinne test
text
C0278245 (UMLS CUI [1])
Item
Webers test
text
C0278247 (UMLS CUI [1])
Webers test
Code List
Webers test
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])
Item
Direction of eye movement with frenzel-lens eyeglasses
text
C0339666 (UMLS CUI [1])
nystagmus
Code List
Direction of eye movement with frenzel-lens eyeglasses
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])
nystagmus
Code List
Amplitude of eye movement with frenzel-lens eyeglasses
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])
nystagmus
Code List
Frequency of eye movement with frenzel lens eyeglasses
CL Item
little (1)
CL Item
medium (2)
CL Item
high (3)
Item
Dizziness with frenzel lens eyeglasses
text
C0012833 (UMLS CUI [1])
dizziness
Code List
Dizziness with frenzel lens eyeglasses
CL Item
little (1)
CL Item
distinctly (2)
CL Item
severe (3)
Item Group
Posturography
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])
Item Group
Tasks of investigator during this visit
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])
Item Group
Comorbidities and concomitant Medication
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])
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