age 18 Years to 75 Years
Item
age 18 Years to 75 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Men and women, 18 to 75 years old.
Item
Men and women, 18 to 75 years old.
boolean
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (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
CL414713 (UMLS CUI 2011AA)
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)
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)
C0341697 (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)
CL421546 (UMLS CUI 2011AA)
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
CL421546 (UMLS CUI 2011AA)
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)
CL414713 (UMLS CUI 2011AA)
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C1518422 (UMLS CUI 2011AA)
CL420107 (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)