ID

43082

Description

ODM derived from http://clinicaltrials.gov/show/NCT01347671

Link

http://clinicaltrials.gov/show/NCT01347671

Keywords

Versions (3)
  1. 3/21/13 3/21/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01347671 Pain

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

age 18 Years to 75 Years
Description

age 18 Years to 75 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Type 1 or type 2 diabetes.
Description

Type 1 or type 2 diabetes.

Data type

boolean

Alias
UMLS CUI 2011AA
C0011854
SNOMED CT 2011_0131
46635009
MedDRA 14.1
10067584
LOINC Version 232
MTHU020217
ICD-10-CM Version 2010
E10
UMLS CUI 2011AA
C0011860
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
Painful DPN symptoms and signs for at least 3 months.
Description

Painful DPN symptoms and signs for at least 3 months.

Data type

boolean

Alias
UMLS CUI 2011AA
C0271680
SNOMED CT 2011_0131
49455004
MedDRA 14.1
10012685
ICD-9-CM Version 2011
357.2
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0037088
SNOMED CT 2011_0131
404684003
Blood glucose controlled with medication.
Description

Blood glucose controlled with medication.

Data type

boolean

Alias
UMLS CUI 2011AA
C0005802
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C0013227
Glycosylated hemoglobin <= 9.5 or 11%, country dependent.
Description

Glycosylated hemoglobin <= 9.5 or 11%, country dependent.

Data type

boolean

Alias
UMLS CUI 2011AA
C0017853
SNOMED CT 2011_0131
259689004
LOINC Version 232
MTHU020323
UMLS CUI 2011AA
C0454664
SNOMED CT 2011_0131
223369002
UMLS CUI 2011AA
C0851827
SNOMED CT 2011_0131
371154000
Prior analgesic medication.
Description

Prior analgesic medication.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0002771
SNOMED CT 2011_0131
53009005
LOINC Version 232
MTHU015955
UMLS CUI 2011AA
C0013227
Average score of >= 4 on the 11 point NRS during the last 3 days prior to randomization.
Description

Average score of >= 4 on the 11 point NRS during the last 3 days prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C1510992
UMLS CUI 2011AA
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
UMLS CUI 2011AA
C1960637
SNOMED CT 2011_0131
425401001
Exclusion Criteria
Description

Exclusion Criteria

Impaired liver, cardiac or renal function.
Description

Impaired liver, cardiac or renal function.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086565
SNOMED CT 2011_0131
75183008
MedDRA 14.1
10019670
UMLS CUI 2011AA
C1290383
SNOMED CT 2011_0131
105981003
UMLS CUI 2011AA
C1565489
SNOMED CT 2011_0131
236423003
MedDRA 14.1
10062237
Breastfeeding and pregnancy.
Description

Breastfeeding and pregnancy.

Data type

boolean

Alias
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
History of substance abuse, alcohol or medication.
Description

History of substance abuse, alcohol or medication.

Data type

boolean

Alias
UMLS CUI 2011AA
C1299544
SNOMED CT 2011_0131
371435006
UMLS CUI 2011AA
C0221628
SNOMED CT 2011_0131
371434005
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1328247
SNOMED CT 2011_0131
417928002
MedDRA 14.1
10000341
Chronic gastrointestinal disease.
Description

Chronic gastrointestinal disease.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0017178
SNOMED CT 2011_0131
119292006
MedDRA 14.1
10017944
History of seizures and or epilepsy.
Description

History of seizures and or epilepsy.

Data type

boolean

Alias
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0852425
MedDRA 14.1
10039912
UMLS CUI 2011AA
C0014544
SNOMED CT 2011_0131
84757009
MedDRA 14.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
Malignant Neoplasms
Description

History or presence of malignancy.

Data type

boolean

Alias
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Presence of painful medical conditions that are not due to diabetic neuropathy, e.g. rheumatoid arthritis.
Description

Presence of painful medical conditions that are not due to diabetic neuropathy, e.g. rheumatoid arthritis.

Data type

boolean

Alias
UMLS CUI 2011AA
C0003873
SNOMED CT 2011_0131
69896004
MedDRA 14.1
10039073
ICD-10-CM Version 2010
M06.9
ICD-9-CM Version 2011
714.0
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0011882
SNOMED CT 2011_0131
230572002
MedDRA 14.1
10012680
ICD-9-CM Version 2011
250.6
Allergies to opioids, acetaminophen or excipients of the medications.
Description

Allergies to opioids, acetaminophen or excipients of the medications.

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0242402
SNOMED CT 2011_0131
360204007
UMLS CUI 2011AA
C0000970
SNOMED CT 2011_0131
387517004
LOINC Version 232
MTHU003399
UMLS CUI 2011AA
C0015237
SNOMED CT 2011_0131
360215002
UMLS CUI 2011AA
C0013227
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age 18 Years to 75 Years
Item
age 18 Years to 75 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Type 1 or type 2 diabetes.
Item
Type 1 or type 2 diabetes.
boolean
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
Painful DPN symptoms and signs for at least 3 months.
Item
Painful DPN symptoms and signs for at least 3 months.
boolean
C0271680 (UMLS CUI 2011AA)
49455004 (SNOMED CT 2011_0131)
10012685 (MedDRA 14.1)
357.2 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0037088 (UMLS CUI 2011AA)
404684003 (SNOMED CT 2011_0131)
Blood glucose controlled with medication.
Item
Blood glucose controlled with medication.
boolean
C0005802 (UMLS CUI 2011AA)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
Glycosylated hemoglobin <= 9.5 or 11%, country dependent.
Item
Glycosylated hemoglobin <= 9.5 or 11%, country dependent.
boolean
C0017853 (UMLS CUI 2011AA)
259689004 (SNOMED CT 2011_0131)
MTHU020323 (LOINC Version 232)
C0454664 (UMLS CUI 2011AA)
223369002 (SNOMED CT 2011_0131)
C0851827 (UMLS CUI 2011AA)
371154000 (SNOMED CT 2011_0131)
Prior analgesic medication.
Item
Prior analgesic medication.
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0002771 (UMLS CUI 2011AA)
53009005 (SNOMED CT 2011_0131)
MTHU015955 (LOINC Version 232)
C0013227 (UMLS CUI 2011AA)
Average score of >= 4 on the 11 point NRS during the last 3 days prior to randomization.
Item
Average score of >= 4 on the 11 point NRS during the last 3 days prior to randomization.
boolean
C1510992 (UMLS CUI 2011AA)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
C1960637 (UMLS CUI 2011AA)
425401001 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
Impaired liver, cardiac or renal function.
Item
Impaired liver, cardiac or renal function.
boolean
C0086565 (UMLS CUI 2011AA)
75183008 (SNOMED CT 2011_0131)
10019670 (MedDRA 14.1)
C1290383 (UMLS CUI 2011AA)
105981003 (SNOMED CT 2011_0131)
C1565489 (UMLS CUI 2011AA)
236423003 (SNOMED CT 2011_0131)
10062237 (MedDRA 14.1)
Breastfeeding and pregnancy.
Item
Breastfeeding and pregnancy.
boolean
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
History of substance abuse, alcohol or medication.
Item
History of substance abuse, alcohol or medication.
boolean
C1299544 (UMLS CUI 2011AA)
371435006 (SNOMED CT 2011_0131)
C0221628 (UMLS CUI 2011AA)
371434005 (SNOMED CT 2011_0131)
392521001 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1328247 (UMLS CUI 2011AA)
417928002 (SNOMED CT 2011_0131)
10000341 (MedDRA 14.1)
Chronic gastrointestinal disease.
Item
Chronic gastrointestinal disease.
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
History of seizures and or epilepsy.
Item
History of seizures and or epilepsy.
boolean
392521001 (SNOMED CT 2011_0131)
C0852425 (UMLS CUI 2011AA)
10039912 (MedDRA 14.1)
C0014544 (UMLS CUI 2011AA)
84757009 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
History or presence of malignancy.
Item
Malignant Neoplasms
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Presence of painful medical conditions that are not due to diabetic neuropathy, e.g. rheumatoid arthritis.
Item
Presence of painful medical conditions that are not due to diabetic neuropathy, e.g. rheumatoid arthritis.
boolean
C0003873 (UMLS CUI 2011AA)
69896004 (SNOMED CT 2011_0131)
10039073 (MedDRA 14.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C1518422 (UMLS CUI 2011AA)
C0011882 (UMLS CUI 2011AA)
230572002 (SNOMED CT 2011_0131)
10012680 (MedDRA 14.1)
250.6 (ICD-9-CM Version 2011)
Allergies to opioids, acetaminophen or excipients of the medications.
Item
Allergies to opioids, acetaminophen or excipients of the medications.
boolean
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0242402 (UMLS CUI 2011AA)
360204007 (SNOMED CT 2011_0131)
C0000970 (UMLS CUI 2011AA)
387517004 (SNOMED CT 2011_0131)
MTHU003399 (LOINC Version 232)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
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