ID
4395
Descripción
ODM derived from http://clinicaltrials.gov/show/NCT00883051
Link
http://clinicaltrials.gov/show/NCT00883051
Palabras clave
Versiones (3)
- 9/12/13 9/12/13 - Martin Dugas
- 17/4/14 17/4/14 - Julian Varghese
- 20/9/21 20/9/21 -
Subido en
9 de diciembre de 2013
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00883051 Migraine Disorders
Eligibility
- StudyEvent: Eligibility
Descripción
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Descripción
History of life threatening or intolerable adverse reaction to any triptan
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C1744706
- UMLS CUI 2011AA
- C2826244
- UMLS CUI 2011AA
- C0041755
- SNOMED CT 2011_0131
- 62014003
- MedDRA 14.1
- 10061623
- ICD-10-CM Version 2010
- T88.7
- UMLS CUI 2011AA
- C1567966
Descripción
Use of prescription migraine prophylactic drugs within 15 days (30 days for flunarizine) prior to Screening Visit and during study participation
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1521941
- LOINC Version 232
- MTHU034709
- UMLS CUI 2011AA
- C0149931
- SNOMED CT 2011_0131
- 37796009
- MedDRA 14.1
- 10027599
- ICD-10-CM Version 2010
- G43
- ICD-9-CM Version 2011
- 346
- UMLS CUI 2011AA
- C0420172
- SNOMED CT 2011_0131
- 33572000
Descripción
Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0949854
- UMLS CUI 2011AA
- C0376266
- UMLS CUI 2011AA
- C0937904
- SNOMED CT 2011_0131
- 417382006
- UMLS CUI 2011AA
- C1142085
- SNOMED CT 2011_0131
- 408381007
- MedDRA 14.1
- 10058734
Descripción
Using 5-HT reuptake inhibitors
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C2911696
Descripción
Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details)
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C2962191
Descripción
Pregnant or breast-feeding women
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
- UMLS CUI 2011AA
- C0043210
- SNOMED CT 2011_0131
- 224526002
Descripción
Women of child-bearing potential not using highly effective contraception
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0043210
- SNOMED CT 2011_0131
- 224526002
- UMLS CUI 2011AA
- C1148523
- UMLS CUI 2011AA
- C0237399
- UMLS CUI 2011AA
- C0420844
- SNOMED CT 2011_0131
- 169450001
Descripción
History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0010068
- SNOMED CT 2011_0131
- 53741008
- MedDRA 14.1
- 10068617
- UMLS CUI 2011AA
- C0948008
- SNOMED CT 2011_0131
- 422504002
- MedDRA 14.1
- 10055221
- UMLS CUI 2011AA
- C0553692
- SNOMED CT 2011_0131
- 230706003
- MedDRA 14.1
- 10019016
- 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
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C0332167
- SNOMED CT 2011_0131
- 15508007
- UMLS CUI 2011AA
- C0036572
- SNOMED CT 2011_0131
- 91175000
- MedDRA 14.1
- 10039910
- ICD-9-CM Version 2011
- 780.39
Descripción
History of hypertension (controlled or uncontrolled)
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C2587213
- SNOMED CT 2011_0131
- 31509003
- UMLS CUI 2011AA
- C0020538
- SNOMED CT 2011_0131
- 38341003
- MedDRA 14.1
- 10020772
- LOINC Version 232
- MTHU020789
- ICD-10-CM Version 2010
- I10
- ICD-9-CM Version 2011
- 997.91
- CTCAE 1105E
- E13785
- UMLS CUI 2011AA
- C1868885
- MedDRA 14.1
- 10066860
Descripción
History of orthostatic hypotension
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0020651
- SNOMED CT 2011_0131
- 28651003
- MedDRA 14.1
- 10031127
- ICD-10-CM Version 2010
- I95.1
- ICD-9-CM Version 2011
- 458.0
Descripción
Current use of hemodynamically active cardiovascular drugs
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0019010
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0007220
- SNOMED CT 2011_0131
- 14833006
Descripción
History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol
Tipo de datos
boolean
Alias
- 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
Descripción
Significant renal or hepatic impairment
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0341697
- SNOMED CT 2011_0131
- 236423003
- MedDRA 14.1
- 10062237
- UMLS CUI 2011AA
- C0948807
- MedDRA 14.1
- 10052254
Descripción
Previous participation in this clinical trial
Tipo de datos
boolean
Alias
- 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
Descripción
Participation in any clinical trial of an experimental drug or device in the previous 30 days
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- C2346570
Descripción
Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1699700
- HL7 V3 2006_05
- MEDCCAT
- UMLS CUI 2011AA
- C0587081
- SNOMED CT 2011_0131
- 118246004
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
- UMLS CUI 2011AA
- C1548788
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
Descripción
Known Hepatitis B or C or HIV infection
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0019163
- SNOMED CT 2011_0131
- 66071002
- MedDRA 14.1
- 10019731
- UMLS CUI 2011AA
- C0019196
- SNOMED CT 2011_0131
- 50711007
- MedDRA 14.1
- 10019744
- ICD-10-CM Version 2010
- B19.20
- ICD-9-CM Version 2011
- 070.7
- UMLS CUI 2011AA
- C0019693
- SNOMED CT 2011_0131
- 86406008
- MedDRA 14.1
- 10020161
- LOINC Version 232
- MTHU020829
- ICD-10-CM Version 2010
- B20
- ICD-9-CM Version 2011
- 042
Descripción
Patients who are employees of the sponsor
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0599987
- SNOMED CT 2011_0131
- 224528001
- UMLS CUI 2011AA
- C2347796
Descripción
Relatives of, or staff directly reporting to, the investigator
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0080103
- SNOMED CT 2011_0131
- 125677006
- UMLS CUI 2011AA
- C0851286
- UMLS CUI 2011AA
- C0700287
- SNOMED CT 2011_0131
- 223458004
- LOINC Version 232
- MTHU002737
- UMLS CUI 2011AA
- CL102947
Descripción
Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144 drug product
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C2974932
- UMLS CUI 2011AA
- C0015237
- SNOMED CT 2011_0131
- 360215002
- UMLS CUI 2011AA
- C0534690
- UMLS CUI 2011AA
- C0243192
Descripción
Patients who were treated with study medication in the COL MIG-201 study (Patients screened but not treated under that protocol are not excluded)
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- C0304229
- SNOMED CT 2011_0131
- 902003
- UMLS CUI 2011AA
- C2974932
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Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
37796009 (SNOMED CT 2011_0131)
10027599 (MedDRA 14.1)
G43 (ICD-10-CM Version 2010)
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10022745 (MedDRA 14.1)
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10027599 (MedDRA 14.1)
G43 (ICD-10-CM Version 2010)
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33572000 (SNOMED CT 2011_0131)
260676000 (SNOMED CT 2011_0131)
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260905004 (SNOMED CT 2011_0131)
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305.90 (ICD-9-CM Version 2011)
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15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
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110465008 (SNOMED CT 2011_0131)
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110465008 (SNOMED CT 2011_0131)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
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50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
C0019693 (UMLS CUI 2011AA)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.1)
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B20 (ICD-10-CM Version 2010)
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224528001 (SNOMED CT 2011_0131)
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125677006 (SNOMED CT 2011_0131)
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223458004 (SNOMED CT 2011_0131)
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CL102947 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C2974932 (UMLS CUI 2011AA)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
C0534690 (UMLS CUI 2011AA)
C0243192 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
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902003 (SNOMED CT 2011_0131)
C2974932 (UMLS CUI 2011AA)