ID

24661

Beschreibung

Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity; ODM derived from: https://clinicaltrials.gov/show/NCT00845338

Link

https://clinicaltrials.gov/show/NCT00845338

Stichworte

Versionen (1)
  1. 12.08.17 12.08.17 -
Hochgeladen am

12. August 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00845338

Englisch

Eligibility Multiple Sclerosis NCT00845338

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with multiple sclerosis for at least 6 months
Beschreibung

Multiple Sclerosis disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0872146
neurogenic detrusor overactivity without dsd
Beschreibung

Detrusor Neurogenic Overactivity | Detrusor and sphincter dyssynergia Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1180419
UMLS CUI [1,2]
C0005697
UMLS CUI [1,3]
C1536696
UMLS CUI [2,1]
C0341747
UMLS CUI [2,2]
C0332197
symptoms of oab
Beschreibung

Overactive Bladder Symptoms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0878773
UMLS CUI [1,2]
C1457887
patients capable of completing the bladder diary
Beschreibung

Urinary frequency volume chart Completion Ability

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0430970
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0085732
patients capable of independent toileting
Beschreibung

Toileting Independently able

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0150810
UMLS CUI [1,2]
C1299583
patients able to swallow the study medication in accordance to the protocol
Beschreibung

Able to swallow Investigational New Drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0013230
body mass index >/= 18,8 kg/qm and </= 35,0 kg/qm
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
documented, dated, written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with drugs known to affect mainly the urinary function 14 days prior to starting completion of the baseline diary for visit 2
Beschreibung

Pharmaceutical Preparations Affecting Urinary function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0042034
participation in a bladder-training program
Beschreibung

Participation Urinary bladder training

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0150474
low compliance bladder (compliance <20 ml/cm h2o)
Beschreibung

Low compliance bladder

Datentyp

boolean

Alias
UMLS CUI [1]
C0489967
dsd, detrusor hyporeflexia / areflexia and bradykinesia / tremor of the external urethral sphincter
Beschreibung

Detrusor and sphincter dyssynergia | Detrusor Hyporeflexia | Detrusor areflexia | Bradykinesia External urethral sphincter | Tremor External urethral sphincter

Datentyp

boolean

Alias
UMLS CUI [1]
C0341747
UMLS CUI [2,1]
C1180419
UMLS CUI [2,2]
C0151888
UMLS CUI [3]
C0403646
UMLS CUI [4,1]
C0233565
UMLS CUI [4,2]
C2330261
UMLS CUI [5,1]
C0040822
UMLS CUI [5,2]
C2330261
indwelling catheter or intermittent self-catheterization
Beschreibung

Indwelling Catheter | Intermittent self-catheterization

Datentyp

boolean

Alias
UMLS CUI [1]
C0007439
UMLS CUI [2]
C0473154
patience with post-void residual (pvr) urinary volume > 200 ml at baseline
Beschreibung

Residual urine volume post void

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0429774
UMLS CUI [1,2]
C1439885
urinary retention or clinically significant bladder outlet obstruction as detected by the investigator
Beschreibung

Urinary Retention | Bladder neck obstruction

Datentyp

boolean

Alias
UMLS CUI [1]
C0080274
UMLS CUI [2]
C0005694
clinically predominant and bothersome stress urinary incontinence
Beschreibung

Urinary Stress Incontinence

Datentyp

boolean

Alias
UMLS CUI [1]
C0042025
neurological diseases other than multiple sclerosis affecting urinary bladder function
Beschreibung

Nervous system disorder Affecting Urinary Bladder function | Exception Multiple Sclerosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005682
UMLS CUI [1,4]
C0031843
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0026769
any urogenital surgery within 12 month prior to visit 1
Beschreibung

Urogenital Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0038912
17 additional exclusion criteria
Beschreibung

Exclusion Criteria Additional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
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Ähnliche Modelle

Eligibility Multiple Sclerosis NCT00845338

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis disease length
Item
patients with multiple sclerosis for at least 6 months
boolean
C0026769 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Detrusor Neurogenic Overactivity | Detrusor and sphincter dyssynergia Absent
Item
neurogenic detrusor overactivity without dsd
boolean
C1180419 (UMLS CUI [1,1])
C0005697 (UMLS CUI [1,2])
C1536696 (UMLS CUI [1,3])
C0341747 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Overactive Bladder Symptoms
Item
symptoms of oab
boolean
C0878773 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Urinary frequency volume chart Completion Ability
Item
patients capable of completing the bladder diary
boolean
C0430970 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
Toileting Independently able
Item
patients capable of independent toileting
boolean
C0150810 (UMLS CUI [1,1])
C1299583 (UMLS CUI [1,2])
Able to swallow Investigational New Drug
Item
patients able to swallow the study medication in accordance to the protocol
boolean
C2712086 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Body mass index
Item
body mass index >/= 18,8 kg/qm and </= 35,0 kg/qm
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
documented, dated, written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Affecting Urinary function
Item
treatment with drugs known to affect mainly the urinary function 14 days prior to starting completion of the baseline diary for visit 2
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0042034 (UMLS CUI [1,3])
Participation Urinary bladder training
Item
participation in a bladder-training program
boolean
C0679823 (UMLS CUI [1,1])
C0150474 (UMLS CUI [1,2])
Low compliance bladder
Item
low compliance bladder (compliance <20 ml/cm h2o)
boolean
C0489967 (UMLS CUI [1])
Detrusor and sphincter dyssynergia | Detrusor Hyporeflexia | Detrusor areflexia | Bradykinesia External urethral sphincter | Tremor External urethral sphincter
Item
dsd, detrusor hyporeflexia / areflexia and bradykinesia / tremor of the external urethral sphincter
boolean
C0341747 (UMLS CUI [1])
C1180419 (UMLS CUI [2,1])
C0151888 (UMLS CUI [2,2])
C0403646 (UMLS CUI [3])
C0233565 (UMLS CUI [4,1])
C2330261 (UMLS CUI [4,2])
C0040822 (UMLS CUI [5,1])
C2330261 (UMLS CUI [5,2])
Indwelling Catheter | Intermittent self-catheterization
Item
indwelling catheter or intermittent self-catheterization
boolean
C0007439 (UMLS CUI [1])
C0473154 (UMLS CUI [2])
Residual urine volume post void
Item
patience with post-void residual (pvr) urinary volume > 200 ml at baseline
boolean
C0429774 (UMLS CUI [1,1])
C1439885 (UMLS CUI [1,2])
Urinary Retention | Bladder neck obstruction
Item
urinary retention or clinically significant bladder outlet obstruction as detected by the investigator
boolean
C0080274 (UMLS CUI [1])
C0005694 (UMLS CUI [2])
Urinary Stress Incontinence
Item
clinically predominant and bothersome stress urinary incontinence
boolean
C0042025 (UMLS CUI [1])
Nervous system disorder Affecting Urinary Bladder function | Exception Multiple Sclerosis
Item
neurological diseases other than multiple sclerosis affecting urinary bladder function
boolean
C0027765 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005682 (UMLS CUI [1,3])
C0031843 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0026769 (UMLS CUI [2,2])
Urogenital Surgical Procedures
Item
any urogenital surgery within 12 month prior to visit 1
boolean
C0038912 (UMLS CUI [1])
Exclusion Criteria Additional
Item
17 additional exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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