ID

43456

Description

ODM derived from http://clinicaltrials.gov/show/NCT00796354

Link

http://clinicaltrials.gov/show/NCT00796354

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/16/14 4/16/14 - 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 NCT00796354 Constipation

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
Age 18 Years to 80 Years
Description

age 18 Years to 80 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Written informed consent obtained.
Description

Written informed consent obtained.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Females of child-bearing potential must employ an adequate method of contraception and must undergo a pregnancy test at Randomisation Visit.
Description

Females of child-bearing potential must employ an adequate method of contraception and must undergo a pregnancy test at Randomisation Visit.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0032976
SNOMED CT 2011_0131
74036000
MedDRA 14.1
10036572
Willing, able and competent to complete the entire study and comply with study instructions.
Description

Willing, able and competent to complete the entire study and comply with study instructions.

Data type

boolean

Alias
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C1554962
HL7 V3 2006_05
C
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0302828
Patients > 50 years old have to have undergone a colonoscopy or computerised tomography (CT) after the onset of their IBS-C symptoms or within the last 5 years.
Description

Patients > 50 years old have to have undergone a colonoscopy or computerised tomography (CT) after the onset of their IBS-C symptoms or within the last 5 years.

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0009378
SNOMED CT 2011_0131
73761001
MedDRA 14.1
10010007
ICD-9-CM Version 2011
45.23
UMLS CUI 2011AA
C0040405
SNOMED CT 2011_0131
77477000
MedDRA 14.1
10010234
HL7 V3 2006_05
0002
UMLS CUI 2011AA
C1868889
SNOMED CT 2011_0131
440630006
MedDRA 14.1
10066868
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Patient has diagnosed IBS-C using Rome III criteria for the last 3 months, with symptom onset at least 6 months prior to diagnosis.
Description

Patient has diagnosed IBS-C using Rome III criteria for the last 3 months, with symptom onset at least 6 months prior to diagnosis.

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1868889
SNOMED CT 2011_0131
440630006
MedDRA 14.1
10066868
UMLS CUI 2011AA
C0035831
UMLS CUI 2011AA
C0439070
SNOMED CT 2011_0131
257471003
UMLS CUI 2011AA
C0679228
UMLS CUI 2011AA
C0566588
SNOMED CT 2011_0131
289172004
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
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.
Description

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.

Data type

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
Abdominal pain of unknown cause, not related to IBS.
Description

Abdominal pain of unknown cause, not related to IBS.

Data type

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
History of - major abdominal surgery
Description

Previous major abdominal surgery.

Data type

boolean

Alias
UMLS CUI 2011AA
C0455612
SNOMED CT 2011_0131
161617006
IBS subtype other than IBS-C.
Description

IBS subtype other than IBS-C.

Data type

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
Known allergy to polyethylene glycol (PEG) 3350 or known hypersensitivity to any of the active substances.
Description

Known allergy to polyethylene glycol (PEG) 3350 or known hypersensitivity to any of the active substances.

Data type

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
Laxative, drug or alcohol abuse (recent history or within previous 12 months).
Description

Laxative, drug or alcohol abuse (recent history or within previous 12 months).

Data type

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
Pregnant or lactating females.
Description

Pregnant or lactating females.

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
Severe or acute disease within 2 weeks prior to the start of the study.
Description

Severe or acute disease within 2 weeks prior to the start of the study.

Data type

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
Patients with type I or II diabetes.
Description

Patients with type I or II 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
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.
Description

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.

Data type

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
Incomplete Patient Diary Card during the run-in period.
Description

Incomplete Patient Diary Card during the run-in period.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205257
SNOMED CT 2011_0131
255599008
UMLS CUI 2011AA
C0018700
UMLS CUI 2011AA
CL432972
The occurrence of diarrhoea during the run-in period.
Description

The occurrence of diarrhoea during the run-in period.

Data type

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
Patients with abnormal laboratory tests, proctoscopy /abdominal ultrasound, colonoscopy, sigmoidoscopy or CT that requires further investigation.
Description

Patients with abnormal laboratory tests, proctoscopy /abdominal ultrasound, colonoscopy, sigmoidoscopy or CT that requires further investigation.

Data type

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
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.
Description

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.

Data type

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
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.
Description

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.

Data type

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
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.
Description

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.

Data type

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
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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
CL425202 (UMLS CUI 2011AA)
age 18 Years to 80 Years
Item
Age 18 Years to 80 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Written informed consent obtained.
Item
Written informed consent obtained.
boolean
C0021430 (UMLS CUI 2011AA)
Females of child-bearing potential must employ an adequate method of contraception and must undergo a pregnancy test at Randomisation Visit.
Item
Females of child-bearing potential must employ an adequate method of contraception and must undergo a pregnancy test at Randomisation Visit.
boolean
C0086287 (UMLS CUI 2011AA)
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)
Willing, able and competent to complete the entire study and comply with study instructions.
Item
Willing, able and competent to complete the entire study and comply with study instructions.
boolean
C0600109 (UMLS CUI 2011AA)
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)
Patients > 50 years old have to have undergone a colonoscopy or computerised tomography (CT) after the onset of their IBS-C symptoms or within the last 5 years.
Item
Patients > 50 years old have to have undergone a colonoscopy or computerised tomography (CT) after the onset of their IBS-C symptoms or within the last 5 years.
boolean
C0001779 (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)
Patient has diagnosed IBS-C using Rome III criteria for the last 3 months, with symptom onset at least 6 months prior to diagnosis.
Item
Patient has diagnosed IBS-C using Rome III criteria for the last 3 months, with symptom onset at least 6 months prior to diagnosis.
boolean
C0011900 (UMLS CUI 2011AA)
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)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
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.
Item
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.
boolean
C0012634 (UMLS CUI 2011AA)
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)
Abdominal pain of unknown cause, not related to IBS.
Item
Abdominal pain of unknown cause, not related to IBS.
boolean
C0000737 (UMLS CUI 2011AA)
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)
Previous major abdominal surgery.
Item
History of - major abdominal surgery
boolean
C0455612 (UMLS CUI 2011AA)
161617006 (SNOMED CT 2011_0131)
IBS subtype other than IBS-C.
Item
IBS subtype other than IBS-C.
boolean
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)
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)
Known allergy to polyethylene glycol (PEG) 3350 or known hypersensitivity to any of the active substances.
Item
Known allergy to polyethylene glycol (PEG) 3350 or known hypersensitivity to any of the active substances.
boolean
C0020517 (UMLS CUI 2011AA)
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)
Laxative, drug or alcohol abuse (recent history or within previous 12 months).
Item
Laxative, drug or alcohol abuse (recent history or within previous 12 months).
boolean
C0149720 (UMLS CUI 2011AA)
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)
Pregnant or lactating females.
Item
Pregnant or lactating females.
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
Severe or acute disease within 2 weeks prior to the start of the study.
Item
Severe or acute disease within 2 weeks prior to the start of the study.
boolean
C0205082 (UMLS CUI 2011AA)
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)
Patients with type I or II diabetes.
Item
Patients with type I or II 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)
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.
Item
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.
boolean
C0205394 (UMLS CUI 2011AA)
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)
Incomplete Patient Diary Card during the run-in period.
Item
Incomplete Patient Diary Card during the run-in period.
boolean
C0205257 (UMLS CUI 2011AA)
255599008 (SNOMED CT 2011_0131)
C0018700 (UMLS CUI 2011AA)
CL432972 (UMLS CUI 2011AA)
The occurrence of diarrhoea during the run-in period.
Item
The occurrence of diarrhoea during the run-in period.
boolean
C0243132 (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)
Patients with abnormal laboratory tests, proctoscopy /abdominal ultrasound, colonoscopy, sigmoidoscopy or CT that requires further investigation.
Item
Patients with abnormal laboratory tests, proctoscopy /abdominal ultrasound, colonoscopy, sigmoidoscopy or CT that requires further investigation.
boolean
C0438215 (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)
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.
Item
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.
boolean
C0348080 (UMLS CUI 2011AA)
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)
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.
Item
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.
boolean
C0679823 (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)
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.
Item
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.
boolean
C0599987 (UMLS CUI 2011AA)
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)
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