ID

13049

Descripción

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

Palabras clave

Versiones (2)
  1. 12/1/16 12/1/16 -
  2. 13/1/16 13/1/16 -
Subido en

13 de enero de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Moxaverine 200mg p.o. in patients with central nervous vertigo 2

Inglés

Case report form Visit 2

1 formularios  
Patient Identification
Descripción

Patient Identification

Patient Number
Descripción

Patient Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1830427
Study site number
Descripción

Study site

Tipo de datos

integer

Alias
UMLS CUI [1]
C2825164
Date of completion of this form
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
otorhinolaryngologic examination
Descripción

otorhinolaryngologic examination

Otoscopy
Descripción

Otoscopy

Tipo de datos

text

Alias
UMLS CUI [1]
C0419361
Rinne test
Descripción

Rinne test

Tipo de datos

text

Alias
UMLS CUI [1]
C0278245
Webers test
Descripción

Webers test

Tipo de datos

text

Alias
UMLS CUI [1]
C0278247
Direction of eye movement with frenzel lens eyeglasses
Descripción

Nystagmus testing with frenzel lens eyeglasses

Tipo de datos

text

Alias
UMLS CUI [1]
C0028738
Amplitude of eye movement with frenzel-lens eyeglasses
Descripción

Nystagmus testing with frenzel lens eyeglasses

Tipo de datos

text

Alias
UMLS CUI [1]
C0028738
Frequency of eye movement with frenzel lens eyeglasses
Descripción

Nystagmus testing with frenzel lens eyeglasses

Tipo de datos

text

Alias
UMLS CUI [1]
C0028738
Dizziness
Descripción

Nystagmus testing with frenzel lens eyeglasses

Tipo de datos

text

Alias
UMLS CUI [1]
C0012833
Please specify findings of Otoscopy
Descripción

Otoscopy

Tipo de datos

text

Alias
UMLS CUI [1]
C0419361
Please specify findings of Rinne test
Descripción

Rinne test

Tipo de datos

text

Alias
UMLS CUI [1]
C0278245
Please specify findings of Webers test
Descripción

Webers test

Tipo de datos

text

Alias
UMLS CUI [1]
C0278247
Posturography
Descripción

Posturography

Any significant findings during computerized dynamic posturography procedure
Descripción

Computerized dynamic posturography procedure

Tipo de datos

text

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

Computerized dynamic posturography procedure report has to be enclosed

Tipo de datos

text

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

Tasks of investigator during this visit

DHI-Questionnaire given to patient
Descripción

Questionnaire

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0034394
Remaining trial medication retrieved from patient?
Descripción

Trial medication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013227
Number of tablets of trial medication retrieved from patient
Descripción

Trial medication

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013227
Following package of trial medication given to patient
Descripción

Trial medication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013227
Any questions the patient might have have been answered.
Descripción

Patient questions

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0547398
Please note questions and answers given
Descripción

Patient questions

Tipo de datos

text

Alias
UMLS CUI [1]
C0547398
Signature date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Signature
Descripción

Signature

Tipo de datos

text

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

Comorbidities and concomitant Medication

Have comorbidities changed?
Descripción

Comorbidities

Tipo de datos

boolean

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

Comorbidities

Tipo de datos

text

Alias
UMLS CUI [1]
C0009488
Has concomitant medication been subject to change?
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347852
Please specify medication name,dose,start and end date or Therapy
Descripción

Concomitant Agent

Tipo de datos

text

Alias
UMLS CUI [1]
C2347852
additional comments
Descripción

additional comments

Tipo de datos

text

Alias
UMLS CUI [1]
C1830770
General impression regarding the trial
Descripción

General impression regarding the trial

General tolerance of trial substance
Descripción

Tolerance

Tipo de datos

text

Alias
UMLS CUI [1]
C0556444
General therapeutic effectiveness
Descripción

Therapeutic effectiveness

Tipo de datos

text

Alias
UMLS CUI [1]
C0087113
Signature Date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Signature
Descripción

Signature

Tipo de datos

text

Alias
UMLS CUI [1]
C1519316
Adverse reactions
Descripción

Adverse reactions

During this trial period,have there been adverse reactions to the study drug?
Descripción

If yes, please give further detailed information below

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0559546
Please specify the adverse event or reaction
Descripción

Adverse event

Tipo de datos

text

Alias
UMLS CUI [1]
C0877248
Severity of adverse event or reaction
Descripción

In case of severe or life-threatening AE, please notify URSAPHARM GmbH (ASAP< 24h) and fill in the enclosed pharmacovigilance form. Phone 06805-9292130, Fax 06805-929288

Tipo de datos

text

Alias
UMLS CUI [1]
C1710066
Treatment of AE
Descripción

If patient has been discontinued from trial,please enclose final report.

Tipo de datos

text

Alias
UMLS CUI [1]
C0087111
Development of adverse event or reaction
Descripción

Development

Tipo de datos

text

Alias
UMLS CUI [1]
C0243107
Association with trial substance
Descripción

Drug association

Tipo de datos

text

Alias
UMLS CUI [1]
C0544075
Please give further information about countermeasures, development,outcome and judgment of the AE
Descripción

additional comments

Tipo de datos

text

Alias
UMLS CUI [1]
C1830770
Signature Date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Signature
Descripción

Signature

Tipo de datos

text

Alias
UMLS CUI [1]
C1519316
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Similar models

Case report form Visit 2

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Patient Identification
Patient Number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Study site
Item
Study site number
integer
C2825164 (UMLS CUI [1])
Date
Item
Date of completion of this form
date
C0011008 (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)
Item
Rinne test
text
C0278245 (UMLS CUI [1])
Rinne test
Code List
Rinne test
CL Item
normal (1)
CL Item
findings (2)
Item
Webers test
text
C0278247 (UMLS CUI [1])
Webers test
Code List
Webers test
CL Item
normal (1)
CL Item
findings (2)
Item
Direction of eye movement with frenzel lens eyeglasses
text
C0028738 (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])
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])
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
text
C0012833 (UMLS CUI [1])
Dizziness
Code List
Dizziness
CL Item
little (1)
CL Item
distinctly (2)
CL Item
severe (3)
Otoscopy
Item
Please specify findings of Otoscopy
text
C0419361 (UMLS CUI [1])
Rinne test
Item
Please specify findings of Rinne test
text
C0278245 (UMLS CUI [1])
Webers test
Item
Please specify findings of Webers test
text
C0278247 (UMLS CUI [1])
Item Group
Posturography
Item
Any significant findings during computerized dynamic posturography procedure
text
C0519978 (UMLS CUI [1])
Computerized dynamic posturography procedure
Code List
Any significant findings during computerized dynamic posturography procedure
CL Item
None (1)
CL Item
Yes (2)
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])
Trial medication
Item
Remaining trial medication retrieved from patient?
boolean
C0013227 (UMLS CUI [1])
Trial medication
Item
Number of tablets of trial medication retrieved from patient
integer
C0013227 (UMLS CUI [1])
Trial medication
Item
Following package of trial medication given to patient
boolean
C0013227 (UMLS CUI [1])
Patient questions
Item
Any questions the patient might have have been answered.
boolean
C0547398 (UMLS CUI [1])
Patient questions
Item
Please note questions and answers given
text
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
Have comorbidities changed?
boolean
C0009488 (UMLS CUI [1])
Comorbidities
Item
Please specify comorbidities by ICD-Code
text
C0009488 (UMLS CUI [1])
Concomitant agent
Item
Has concomitant medication been subject to change?
boolean
C2347852 (UMLS CUI [1])
Concomitant Agent
Item
Please specify medication name,dose,start and end date or Therapy
text
C2347852 (UMLS CUI [1])
additional comments
Item
additional comments
text
C1830770 (UMLS CUI [1])
Item Group
General impression regarding the trial
Item
General tolerance of trial substance
text
C0556444 (UMLS CUI [1])
Tolerance
Code List
General tolerance of trial substance
CL Item
very good (1)
CL Item
good (2)
CL Item
fair (3)
CL Item
poor (4)
Item
General therapeutic effectiveness
text
C0087113 (UMLS CUI [1])
Therapeutic effectiveness
Code List
General therapeutic effectiveness
CL Item
Very good (1)
CL Item
Good (2)
CL Item
Fair (3)
CL Item
Poor (4)
Date
Item
Signature Date
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
Item Group
Adverse reactions
adverse reaction
Item
During this trial period,have there been adverse reactions to the study drug?
boolean
C0559546 (UMLS CUI [1])
Adverse event
Item
Please specify the adverse event or reaction
text
C0877248 (UMLS CUI [1])
Item
Severity of adverse event or reaction
text
C1710066 (UMLS CUI [1])
Severity of Adverse Event
Code List
Severity of adverse event or reaction
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Life threatening (4)
Item
Treatment of AE
text
C0087111 (UMLS CUI [1])
Treatment
Code List
Treatment of AE
CL Item
None (1)
CL Item
dose reduction (2)
CL Item
dose omission (3)
CL Item
discontinuation (4)
CL Item
antidote (5)
CL Item
concomitant medication changed (6)
CL Item
other (7)
Item
Development of adverse event or reaction
text
C0243107 (UMLS CUI [1])
Development
Code List
Development of adverse event or reaction
CL Item
subsided (1)
CL Item
decreased (2)
CL Item
persistent (3)
CL Item
increased (4)
CL Item
fatal (5)
CL Item
unknown (6)
CL Item
other (7)
Item
Association with trial substance
text
C0544075 (UMLS CUI [1])
Drug association
Code List
Association with trial substance
CL Item
by underlying disease (1)
CL Item
none (2)
CL Item
possible (3)
CL Item
likely (4)
CL Item
affirmative (5)
additional comments
Item
Please give further information about countermeasures, development,outcome and judgment of the AE
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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