ID
5002
Beschreibung
ODM derived from http://clinicaltrials.gov/show/NCT00796354
Link
http://clinicaltrials.gov/show/NCT00796354
Stichworte
Versionen (3)
- 09.12.13 09.12.13 - Martin Dugas
- 16.04.14 16.04.14 - Julian Varghese
- 20.09.21 20.09.21 -
Hochgeladen am
16. April 2014
DOI
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Lizenz
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Eligibility NCT00796354 Constipation
Eligibility
- StudyEvent: Eligibility
Beschreibung
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Beschreibung
History or evidence of organic disease in the large bowel, intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract such as Crohn's disease, complicated diverticulitis, ulcerative colitis, toxic megacolon and occlusive or subocclusive syndrome.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C0021851
- SNOMED CT 2011_0131
- 14742008
- UMLS CUI 2011AA
- C0021845
- SNOMED CT 2011_0131
- 56905009
- MedDRA 14.1
- 10022694
- ICD-9-CM Version 2011
- 569.83
- UMLS CUI 2011AA
- C0021843
- SNOMED CT 2011_0131
- 81060008
- MedDRA 14.1
- 10022687
- ICD-10-CM Version 2010
- K56.60
- ICD-9-CM Version 2011
- 560.9
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C0836201
- UMLS CUI 2011AA
- C1258215
- SNOMED CT 2011_0131
- 81060008
- MedDRA 14.1
- 10021328
- CTCAE 1105E
- E10812
- UMLS CUI 2011AA
- C0021390
- SNOMED CT 2011_0131
- 24526004
- MedDRA 14.1
- 10021972
- UMLS CUI 2011AA
- C0010346
- SNOMED CT 2011_0131
- 34000006
- MedDRA 14.1
- 10011401
- ICD-10-CM Version 2010
- K50.9
- UMLS CUI 2011AA
- C0012813
- SNOMED CT 2011_0131
- 307496006
- MedDRA 14.1
- 10013538
- UMLS CUI 2011AA
- C0302596
- SNOMED CT 2011_0131
- 64766004
- MedDRA 14.1
- 10009900
- ICD-10-CM Version 2010
- K51
- ICD-9-CM Version 2011
- 556
- UMLS CUI 2011AA
- C0025162
- SNOMED CT 2011_0131
- 28536002
- MedDRA 14.1
- 10027115
- ICD-10-CM Version 2010
- K59.3
- UMLS CUI 2011AA
- C1168278
- MedDRA 14.1
- 10059670
Beschreibung
Abdominal pain of unknown cause, not related to IBS.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0000737
- SNOMED CT 2011_0131
- 21522001
- MedDRA 14.1
- 10000081
- LOINC Version 232
- MTHU013636
- ICD-10-CM Version 2010
- R10.9
- ICD-9-CM Version 2011
- 789.0
- CTCAE 1105E
- E10460
- UMLS CUI 2011AA
- C0439673
- SNOMED CT 2011_0131
- 261665006
- UMLS CUI 2011AA
- C1314792
- SNOMED CT 2011_0131
- 134198009
- UMLS CUI 2011AA
- CL414700
- UMLS CUI 2011AA
- C0022104
- SNOMED CT 2011_0131
- 10743008
- MedDRA 14.1
- 10023003
- ICD-10-CM Version 2010
- K58
- ICD-9-CM Version 2011
- 564.1
Beschreibung
Previous major abdominal surgery.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0455612
- SNOMED CT 2011_0131
- 161617006
Beschreibung
IBS subtype other than IBS-C.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0022104
- SNOMED CT 2011_0131
- 10743008
- MedDRA 14.1
- 10023003
- ICD-10-CM Version 2010
- K58
- ICD-9-CM Version 2011
- 564.1
- UMLS CUI 2011AA
- C0449560
- SNOMED CT 2011_0131
- 260837004
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C1868889
- SNOMED CT 2011_0131
- 440630006
- MedDRA 14.1
- 10066868
Beschreibung
Known allergy to polyethylene glycol (PEG) 3350 or known hypersensitivity to any of the active substances.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 257550005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0724672
- SNOMED CT 2011_0131
- 424535007
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0439861
- SNOMED CT 2011_0131
- 105590001
Beschreibung
Laxative, drug or alcohol abuse (recent history or within previous 12 months).
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0149720
- SNOMED CT 2011_0131
- 280982009
- MedDRA 14.1
- 10024043
- ICD-10-CM Version 2010
- F55.2
- UMLS CUI 2011AA
- C0013146
- SNOMED CT 2011_0131
- 26416006
- MedDRA 14.1
- 10013654
- LOINC Version 232
- LP36310-8
- ICD-9-CM Version 2011
- 305.90
- UMLS CUI 2011AA
- C0085762
- SNOMED CT 2011_0131
- 15167005
- MedDRA 14.1
- 10001584
- LOINC Version 232
- LP36309-0
- ICD-10-CM Version 2010
- F10.1
- ICD-9-CM Version 2011
- 305.0
Beschreibung
Pregnant or lactating females.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C2828358
- UMLS CUI 2011AA
- C0015780
- SNOMED CT 2011_0131
- 248152002
- HL7 V3 2006_05
- F
Beschreibung
Severe or acute disease within 2 weeks prior to the start of the study.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C0001314
- SNOMED CT 2011_0131
- 2704003
- UMLS CUI 2011AA
- C0439230
- SNOMED CT 2011_0131
- 258705008
- HL7 V3 2006_05
- WK
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C2348558
Beschreibung
Patients with type I or II diabetes.
Datentyp
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
Beschreibung
Use of other investigational drugs, prescribed or OTC medications affecting gastrointestinal function such as anticholinergics, prokinetics, drugs affecting motility, anthraquinones, opioids,ondansetron or other 5-HT3 antagonists.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- C0392760
- SNOMED CT 2011_0131
- 247591002
- UMLS CUI 2011AA
- C0516983
- UMLS CUI 2011AA
- C0242896
- SNOMED CT 2011_0131
- 14601000
- UMLS CUI 2011AA
- C1268865
- SNOMED CT 2011_0131
- 116532005
- UMLS CUI 2011AA
- C0392760
- SNOMED CT 2011_0131
- 247591002
- UMLS CUI 2011AA
- C0017184
- UMLS CUI 2011AA
- C0003174
- SNOMED CT 2011_0131
- 116283009
- LOINC Version 232
- MTHU015517
- UMLS CUI 2011AA
- C0242402
- SNOMED CT 2011_0131
- 360204007
- UMLS CUI 2011AA
- C0061851
- SNOMED CT 2011_0131
- 108418007
- UMLS CUI 2011AA
- C2936526
Beschreibung
Incomplete Patient Diary Card during the run-in period.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0205257
- SNOMED CT 2011_0131
- 255599008
- UMLS CUI 2011AA
- C0018700
- UMLS CUI 2011AA
- CL432972
Beschreibung
The occurrence of diarrhoea during the run-in period.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0243132
- UMLS CUI 2011AA
- C0011991
- SNOMED CT 2011_0131
- 62315008
- MedDRA 14.1
- 10012735
- LOINC Version 232
- MTHU013347
- ICD-10-CM Version 2010
- R19.7
- ICD-9-CM Version 2011
- 787.91
- CTCAE 1105E
- E10572
- UMLS CUI 2011AA
- CL432972
Beschreibung
Patients with abnormal laboratory tests, proctoscopy /abdominal ultrasound, colonoscopy, sigmoidoscopy or CT that requires further investigation.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0438215
- SNOMED CT 2011_0131
- 165346000
- MedDRA 14.1
- 10023547
- UMLS CUI 2011AA
- C0033251
- SNOMED CT 2011_0131
- 42238002
- MedDRA 14.1
- 10036786
- UMLS CUI 2011AA
- C2348813
- UMLS CUI 2011AA
- C0009378
- SNOMED CT 2011_0131
- 73761001
- MedDRA 14.1
- 10010007
- ICD-9-CM Version 2011
- 45.23
- UMLS CUI 2011AA
- C0037075
- SNOMED CT 2011_0131
- 24420007
- MedDRA 14.1
- 10040669
- UMLS CUI 2011AA
- C0040405
- SNOMED CT 2011_0131
- 77477000
- MedDRA 14.1
- 10010234
- HL7 V3 2006_05
- 0002
Beschreibung
Patients with any condition, which, in the Investigator's may put the patient at significant risk, may confound the study results, or may interfere significantly with the results of the study.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C0678227
- SNOMED CT 2011_0131
- 23981006
- UMLS CUI 2011AA
- C0035647
- SNOMED CT 2011_0131
- 30207005
- HL7 V3 2006_05
- RSK
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C0683954
Beschreibung
Participation in another clinical study of drugs or devices parallel to or less than 1 month before study entry, or previous participation in this study.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0205156
- SNOMED CT 2011_0131
- 9130008
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0150312
- SNOMED CT 2011_0131
- 52101004
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
Beschreibung
Employees of the Investigator or study site with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, as well as family members of the employees or the Investigator.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0599987
- SNOMED CT 2011_0131
- 224528001
- UMLS CUI 2011AA
- C2825164
- UMLS CUI 2011AA
- C1314939
- SNOMED CT 2011_0131
- 248448006
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0086282
- SNOMED CT 2011_0131
- 303071001
- HL7 V3 2006_05
- FAMMEMB
Ähnliche Modelle
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0032976 (UMLS CUI 2011AA)
74036000 (SNOMED CT 2011_0131)
10036572 (MedDRA 14.1)
225466006 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0302828 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0009378 (UMLS CUI 2011AA)
73761001 (SNOMED CT 2011_0131)
10010007 (MedDRA 14.1)
45.23 (ICD-9-CM Version 2011)
C0040405 (UMLS CUI 2011AA)
77477000 (SNOMED CT 2011_0131)
10010234 (MedDRA 14.1)
0002 (HL7 V3 2006_05)
C1868889 (UMLS CUI 2011AA)
440630006 (SNOMED CT 2011_0131)
10066868 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1868889 (UMLS CUI 2011AA)
440630006 (SNOMED CT 2011_0131)
10066868 (MedDRA 14.1)
C0035831 (UMLS CUI 2011AA)
C0439070 (UMLS CUI 2011AA)
257471003 (SNOMED CT 2011_0131)
C0679228 (UMLS CUI 2011AA)
C0566588 (UMLS CUI 2011AA)
289172004 (SNOMED CT 2011_0131)
64572001 (SNOMED CT 2011_0131)
C0021851 (UMLS CUI 2011AA)
14742008 (SNOMED CT 2011_0131)
C0021845 (UMLS CUI 2011AA)
56905009 (SNOMED CT 2011_0131)
10022694 (MedDRA 14.1)
569.83 (ICD-9-CM Version 2011)
C0021843 (UMLS CUI 2011AA)
81060008 (SNOMED CT 2011_0131)
10022687 (MedDRA 14.1)
K56.60 (ICD-10-CM Version 2010)
560.9 (ICD-9-CM Version 2011)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0836201 (UMLS CUI 2011AA)
C1258215 (UMLS CUI 2011AA)
81060008 (SNOMED CT 2011_0131)
10021328 (MedDRA 14.1)
E10812 (CTCAE 1105E)
C0021390 (UMLS CUI 2011AA)
24526004 (SNOMED CT 2011_0131)
10021972 (MedDRA 14.1)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0012813 (UMLS CUI 2011AA)
307496006 (SNOMED CT 2011_0131)
10013538 (MedDRA 14.1)
C0302596 (UMLS CUI 2011AA)
64766004 (SNOMED CT 2011_0131)
10009900 (MedDRA 14.1)
K51 (ICD-10-CM Version 2010)
556 (ICD-9-CM Version 2011)
C0025162 (UMLS CUI 2011AA)
28536002 (SNOMED CT 2011_0131)
10027115 (MedDRA 14.1)
K59.3 (ICD-10-CM Version 2010)
C1168278 (UMLS CUI 2011AA)
10059670 (MedDRA 14.1)
21522001 (SNOMED CT 2011_0131)
10000081 (MedDRA 14.1)
MTHU013636 (LOINC Version 232)
R10.9 (ICD-10-CM Version 2010)
789.0 (ICD-9-CM Version 2011)
E10460 (CTCAE 1105E)
C0439673 (UMLS CUI 2011AA)
261665006 (SNOMED CT 2011_0131)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
CL414700 (UMLS CUI 2011AA)
C0022104 (UMLS CUI 2011AA)
10743008 (SNOMED CT 2011_0131)
10023003 (MedDRA 14.1)
K58 (ICD-10-CM Version 2010)
564.1 (ICD-9-CM Version 2011)
161617006 (SNOMED CT 2011_0131)
10743008 (SNOMED CT 2011_0131)
10023003 (MedDRA 14.1)
K58 (ICD-10-CM Version 2010)
564.1 (ICD-9-CM Version 2011)
C0449560 (UMLS CUI 2011AA)
260837004 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C1868889 (UMLS CUI 2011AA)
440630006 (SNOMED CT 2011_0131)
10066868 (MedDRA 14.1)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0724672 (UMLS CUI 2011AA)
424535007 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0439861 (UMLS CUI 2011AA)
105590001 (SNOMED CT 2011_0131)
280982009 (SNOMED CT 2011_0131)
10024043 (MedDRA 14.1)
F55.2 (ICD-10-CM Version 2010)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
24484000 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0001314 (UMLS CUI 2011AA)
2704003 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (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)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0516983 (UMLS CUI 2011AA)
C0242896 (UMLS CUI 2011AA)
14601000 (SNOMED CT 2011_0131)
C1268865 (UMLS CUI 2011AA)
116532005 (SNOMED CT 2011_0131)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0017184 (UMLS CUI 2011AA)
C0003174 (UMLS CUI 2011AA)
116283009 (SNOMED CT 2011_0131)
MTHU015517 (LOINC Version 232)
C0242402 (UMLS CUI 2011AA)
360204007 (SNOMED CT 2011_0131)
C0061851 (UMLS CUI 2011AA)
108418007 (SNOMED CT 2011_0131)
C2936526 (UMLS CUI 2011AA)
255599008 (SNOMED CT 2011_0131)
C0018700 (UMLS CUI 2011AA)
CL432972 (UMLS CUI 2011AA)
C0011991 (UMLS CUI 2011AA)
62315008 (SNOMED CT 2011_0131)
10012735 (MedDRA 14.1)
MTHU013347 (LOINC Version 232)
R19.7 (ICD-10-CM Version 2010)
787.91 (ICD-9-CM Version 2011)
E10572 (CTCAE 1105E)
CL432972 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
C0033251 (UMLS CUI 2011AA)
42238002 (SNOMED CT 2011_0131)
10036786 (MedDRA 14.1)
C2348813 (UMLS CUI 2011AA)
C0009378 (UMLS CUI 2011AA)
73761001 (SNOMED CT 2011_0131)
10010007 (MedDRA 14.1)
45.23 (ICD-9-CM Version 2011)
C0037075 (UMLS CUI 2011AA)
24420007 (SNOMED CT 2011_0131)
10040669 (MedDRA 14.1)
C0040405 (UMLS CUI 2011AA)
77477000 (SNOMED CT 2011_0131)
10010234 (MedDRA 14.1)
0002 (HL7 V3 2006_05)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0683954 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
224528001 (SNOMED CT 2011_0131)
C2825164 (UMLS CUI 2011AA)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0086282 (UMLS CUI 2011AA)
303071001 (SNOMED CT 2011_0131)
FAMMEMB (HL7 V3 2006_05)