ID

30943

Beskrivning

Duloxetine for Multiple Sclerosis Pain; ODM derived from: https://clinicaltrials.gov/show/NCT00755807

Länk

https://clinicaltrials.gov/show/NCT00755807

Nyckelord

Versioner (1)
  1. 2018-07-05 2018-07-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 juli 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Multiple Sclerosis NCT00755807

Engelsk

Eligibility Multiple Sclerosis NCT00755807

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
have central neuropathic pain due to multiple sclerosis (ms) based on the disease diagnostic criteria
Beskrivning

Central neuropathic pain Due to Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4087506
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0026769
adult males or females
Beskrivning

Adult

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
have a score of 4 or greater on the daily 24-hour average pain score
Beskrivning

Pain score Average 24 Hours Daily

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0582148
UMLS CUI [1,2]
C1510992
UMLS CUI [1,3]
C1442770
UMLS CUI [1,4]
C0332173
females must test negative for pregnancy at study entry
Beskrivning

Gender Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0427780
complete the daily diaries for at least 70% of the days of the study
Beskrivning

Subject Diary Completion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0205197
participants may continue other prescription and nonprescription analgesic pain medications as long as the dose has been stable for 1 month prior to study entry, and they agree to maintain that stable dose throughout the study disease diagnostic criteria:
Beskrivning

Analgesic Pain Reliever Dose Stable | Analgesic Pain Reliever Non-Prescription Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0939253
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0939253
UMLS CUI [2,2]
C0013231
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
diagnosis of ms at least 1 year prior to study entry
Beskrivning

Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0026769
no ms flares or change in disease treatment for the 3 months prior to study entry
Beskrivning

Multiple sclerosis relapse Absent | Therapy change Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0856120
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3665894
UMLS CUI [2,2]
C0332197
daily pain due to ms for a minimum of 3 months prior to study entry
Beskrivning

Pain daily Due to Multiple Sclerosis | Pain daily Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3845611
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0026769
UMLS CUI [2,1]
C3845611
UMLS CUI [2,2]
C0449238
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
are currently in a clinical trial of ms disease-modifying therapy
Beskrivning

Study Subject Participation Status | Multiple Sclerosis Modification Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0026769
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0087111
have pain that cannot be clearly differentiated from causes other than ms
Beskrivning

Pain | Cause Determination Difficult | Exception Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0030193
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C1148554
UMLS CUI [2,3]
C0332218
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0026769
any current or historical diagnosis of mania, bipolar disorder, psychosis, or schizoaffective disorder
Beskrivning

Manic Disorder | Bipolar Disorder | Psychotic Disorders | Schizoaffective Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0024713
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0033975
UMLS CUI [4]
C0036337
history of substance abuse or dependence
Beskrivning

Substance Use Disorders | Substance Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
are pregnant or breast-feeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Tillbaka till toppen

Similar models

Eligibility Multiple Sclerosis NCT00755807

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Central neuropathic pain Due to Multiple Sclerosis
Item
have central neuropathic pain due to multiple sclerosis (ms) based on the disease diagnostic criteria
boolean
C4087506 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0026769 (UMLS CUI [1,3])
Adult
Item
adult males or females
boolean
C0001675 (UMLS CUI [1])
Pain score Average 24 Hours Daily
Item
have a score of 4 or greater on the daily 24-hour average pain score
boolean
C0582148 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
C1442770 (UMLS CUI [1,3])
C0332173 (UMLS CUI [1,4])
Gender Pregnancy test negative
Item
females must test negative for pregnancy at study entry
boolean
C0079399 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Subject Diary Completion
Item
complete the daily diaries for at least 70% of the days of the study
boolean
C3890583 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Analgesic Pain Reliever Dose Stable | Analgesic Pain Reliever Non-Prescription Dose Stable
Item
participants may continue other prescription and nonprescription analgesic pain medications as long as the dose has been stable for 1 month prior to study entry, and they agree to maintain that stable dose throughout the study disease diagnostic criteria:
boolean
C0939253 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0939253 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Multiple Sclerosis
Item
diagnosis of ms at least 1 year prior to study entry
boolean
C0026769 (UMLS CUI [1])
Multiple sclerosis relapse Absent | Therapy change Absent
Item
no ms flares or change in disease treatment for the 3 months prior to study entry
boolean
C0856120 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3665894 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Pain daily Due to Multiple Sclerosis | Pain daily Duration
Item
daily pain due to ms for a minimum of 3 months prior to study entry
boolean
C3845611 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0026769 (UMLS CUI [1,3])
C3845611 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Multiple Sclerosis Modification Therapy
Item
are currently in a clinical trial of ms disease-modifying therapy
boolean
C2348568 (UMLS CUI [1])
C0026769 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Pain | Cause Determination Difficult | Exception Multiple Sclerosis
Item
have pain that cannot be clearly differentiated from causes other than ms
boolean
C0030193 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C1148554 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0026769 (UMLS CUI [3,2])
Manic Disorder | Bipolar Disorder | Psychotic Disorders | Schizoaffective Disorder
Item
any current or historical diagnosis of mania, bipolar disorder, psychosis, or schizoaffective disorder
boolean
C0024713 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0036337 (UMLS CUI [4])
Substance Use Disorders | Substance Dependence
Item
history of substance abuse or dependence
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial