ID

24661

Description

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

Keywords

Versions (1)
  1. 8/12/17 8/12/17 -
Uploaded on

August 12, 2017

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00845338

English

Eligibility Multiple Sclerosis NCT00845338

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Multiple Sclerosis disease length

Data type

boolean

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

Detrusor Neurogenic Overactivity | Detrusor and sphincter dyssynergia Absent

Data type

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
Description

Overactive Bladder Symptoms

Data type

boolean

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

Urinary frequency volume chart Completion Ability

Data type

boolean

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

Toileting Independently able

Data type

boolean

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

Able to swallow Investigational New Drug

Data type

boolean

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

Body mass index

Data type

boolean

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

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

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
Description

Pharmaceutical Preparations Affecting Urinary function

Data type

boolean

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

Participation Urinary bladder training

Data type

boolean

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

Low compliance bladder

Data type

boolean

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

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

Data type

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
Description

Indwelling Catheter | Intermittent self-catheterization

Data type

boolean

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

Residual urine volume post void

Data type

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
Description

Urinary Retention | Bladder neck obstruction

Data type

boolean

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

Urinary Stress Incontinence

Data type

boolean

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

Nervous system disorder Affecting Urinary Bladder function | Exception Multiple Sclerosis

Data type

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
Description

Urogenital Surgical Procedures

Data type

boolean

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

Exclusion Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Multiple Sclerosis NCT00845338

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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