ID

25348

Description

Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00464061

Lien

https://clinicaltrials.gov/show/NCT00464061

Mots-clés

Versions (1)
  1. 01/09/2017 01/09/2017 -
Téléchargé le

1 septembre 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Sleep Initiation and Maintenance Disorders NCT00464061

Anglais

Eligibility Sleep Initiation and Maintenance Disorders NCT00464061

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of primary insomnia based on diagnostic and statistical manual of mental disorders (fourth edition) criteria
Description

Primary Insomnia

Type de données

boolean

Alias
UMLS CUI [1]
C0033139
disturbances of sleep maintenance criteria based on patient's information related to sleep pattern during the preceding month
Description

Sleep Initiation and Maintenance Disorders | Patient Sleep pattern

Type de données

boolean

Alias
UMLS CUI [1]
C0021603
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0474396
sub-study :
Description

Clinical Trial Part

Type de données

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449719
patients will be included if they have an established medical diagnosis of type ii diabetes mellitus, and have been treated either with an oral hypoglycemic agent and/or insulin for at least three months prior to the screening visit (with stable regimen for at least one month prior to screening)
Description

Diabetes Mellitus, Non-Insulin-Dependent | Oral hypoglycemic Dose Stable | Insulin Dose Stable

Type de données

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0359086
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0021641
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
females who are lactating or who are pregnant
Description

Breast Feeding | Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
night shift workers, and individuals who nap 3 or more times per week over the preceding month
Description

Night shift worker | Nap Frequency

Type de données

boolean

Alias
UMLS CUI [1]
C0555008
UMLS CUI [2,1]
C0870935
UMLS CUI [2,2]
C0439603
consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day
Description

Beverages Containing Xanthine or xanthine derivative | Tea cups/day | Coffee cups/day | Cola drink

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005329
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0043315
UMLS CUI [2,1]
C0039400
UMLS CUI [2,2]
C0560654
UMLS CUI [3,1]
C0009237
UMLS CUI [3,2]
C0560654
UMLS CUI [4]
C0452444
participation in another trial having received study medication within 1 month before the screening visit
Description

Study Subject Participation Status | Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
body mass index ≥ 33
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, st. john's wort, alluna or prescription sleep medication
Description

Drugs, Non-Prescription | Tryptophan | valerian root extract | Kava preparation | Melatonin | ST. JOHN'S WORT EXTRACT | Sleep Disorder Agents

Type de données

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C0041249
UMLS CUI [3]
C0795674
UMLS CUI [4]
C0939882
UMLS CUI [5]
C0025219
UMLS CUI [6]
C0813171
UMLS CUI [7]
C4020625
use of any substance with psychotropic effects or properties know to affect sleep/wake
Description

Psychotropic Drugs Affecting Sleep | Psychotropic Drugs Affecting Wake

Type de données

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0037313
UMLS CUI [2,1]
C0033978
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0442696
history of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia
Description

Primary Hypersomnia | Narcolepsy | Breathing-related sleep disorder | Sleep Disorders, Circadian Rhythm | Parasomnia | Dyssomnias

Type de données

boolean

Alias
UMLS CUI [1]
C0033138
UMLS CUI [2]
C0027404
UMLS CUI [3]
C0236845
UMLS CUI [4]
C0877792
UMLS CUI [5]
C0030508
UMLS CUI [6]
C0700201
clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder
Description

Disease Severe | Disease Unstable | Progressive Disease | Progressive Disease chronic | Disease Due to Operative Surgical Procedures

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C1335499
UMLS CUI [4,1]
C1335499
UMLS CUI [4,2]
C0205191
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0543467
positive qualitative urine drug screen (opiates, cocaine, amphetamine…)
Description

Urine drug screen positive | Opiates | Cocaine | Amphetamine

Type de données

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C0376196
UMLS CUI [3]
C0009170
UMLS CUI [4]
C0002658
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Description

Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Sleep Initiation and Maintenance Disorders NCT00464061

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Primary Insomnia
Item
diagnosis of primary insomnia based on diagnostic and statistical manual of mental disorders (fourth edition) criteria
boolean
C0033139 (UMLS CUI [1])
Sleep Initiation and Maintenance Disorders | Patient Sleep pattern
Item
disturbances of sleep maintenance criteria based on patient's information related to sleep pattern during the preceding month
boolean
C0021603 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0474396 (UMLS CUI [2,2])
Clinical Trial Part
Item
sub-study :
boolean
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent | Oral hypoglycemic Dose Stable | Insulin Dose Stable
Item
patients will be included if they have an established medical diagnosis of type ii diabetes mellitus, and have been treated either with an oral hypoglycemic agent and/or insulin for at least three months prior to the screening visit (with stable regimen for at least one month prior to screening)
boolean
C0011860 (UMLS CUI [1])
C0359086 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0021641 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Breast Feeding | Pregnancy
Item
females who are lactating or who are pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Night shift worker | Nap Frequency
Item
night shift workers, and individuals who nap 3 or more times per week over the preceding month
boolean
C0555008 (UMLS CUI [1])
C0870935 (UMLS CUI [2,1])
C0439603 (UMLS CUI [2,2])
Beverages Containing Xanthine or xanthine derivative | Tea cups/day | Coffee cups/day | Cola drink
Item
consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day
boolean
C0005329 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0043315 (UMLS CUI [1,3])
C0039400 (UMLS CUI [2,1])
C0560654 (UMLS CUI [2,2])
C0009237 (UMLS CUI [3,1])
C0560654 (UMLS CUI [3,2])
C0452444 (UMLS CUI [4])
Study Subject Participation Status | Investigational New Drugs
Item
participation in another trial having received study medication within 1 month before the screening visit
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Body mass index
Item
body mass index ≥ 33
boolean
C1305855 (UMLS CUI [1])
Drugs, Non-Prescription | Tryptophan | valerian root extract | Kava preparation | Melatonin | ST. JOHN'S WORT EXTRACT | Sleep Disorder Agents
Item
use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, st. john's wort, alluna or prescription sleep medication
boolean
C0013231 (UMLS CUI [1])
C0041249 (UMLS CUI [2])
C0795674 (UMLS CUI [3])
C0939882 (UMLS CUI [4])
C0025219 (UMLS CUI [5])
C0813171 (UMLS CUI [6])
C4020625 (UMLS CUI [7])
Psychotropic Drugs Affecting Sleep | Psychotropic Drugs Affecting Wake
Item
use of any substance with psychotropic effects or properties know to affect sleep/wake
boolean
C0033978 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
C0033978 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0442696 (UMLS CUI [2,3])
Primary Hypersomnia | Narcolepsy | Breathing-related sleep disorder | Sleep Disorders, Circadian Rhythm | Parasomnia | Dyssomnias
Item
history of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia
boolean
C0033138 (UMLS CUI [1])
C0027404 (UMLS CUI [2])
C0236845 (UMLS CUI [3])
C0877792 (UMLS CUI [4])
C0030508 (UMLS CUI [5])
C0700201 (UMLS CUI [6])
Disease Severe | Disease Unstable | Progressive Disease | Progressive Disease chronic | Disease Due to Operative Surgical Procedures
Item
clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder
boolean
C0012634 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C1335499 (UMLS CUI [3])
C1335499 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0543467 (UMLS CUI [5,3])
Urine drug screen positive | Opiates | Cocaine | Amphetamine
Item
positive qualitative urine drug screen (opiates, cocaine, amphetamine…)
boolean
C0743300 (UMLS CUI [1])
C0376196 (UMLS CUI [2])
C0009170 (UMLS CUI [3])
C0002658 (UMLS CUI [4])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
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