ID

30943

Description

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

Link

https://clinicaltrials.gov/show/NCT00755807

Keywords

Versions (1)
  1. 7/5/18 7/5/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 5, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00755807

English

Eligibility Multiple Sclerosis NCT00755807

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Central neuropathic pain Due to Multiple Sclerosis

Data type

boolean

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

Adult

Data type

boolean

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

Pain score Average 24 Hours Daily

Data type

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
Description

Gender Pregnancy test negative

Data type

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
Description

Subject Diary Completion

Data type

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:
Description

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

Data type

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
Description

Multiple Sclerosis

Data type

boolean

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

Multiple sclerosis relapse Absent | Therapy change Absent

Data type

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
Description

Pain daily Due to Multiple Sclerosis | Pain daily Duration

Data type

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
Description

Exclusion Criteria

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

Study Subject Participation Status | Multiple Sclerosis Modification Therapy

Data type

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
Description

Pain | Cause Determination Difficult | Exception Multiple Sclerosis

Data type

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
Description

Manic Disorder | Bipolar Disorder | Psychotic Disorders | Schizoaffective Disorder

Data type

boolean

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

Substance Use Disorders | Substance Dependence

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Multiple Sclerosis NCT00755807

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