ID

4342

Description

ODM derived from http://clinicaltrials.gov/show/NCT01021670

Link

http://clinicaltrials.gov/show/NCT01021670

Keywords

Versions (1)
  1. 12/7/13 12/7/13 - Martin Dugas
Uploaded on

December 7, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01021670 Sexual Dysfunction, Physiological

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 64 Years
Description

age 18 Years to 64 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
In accordance with the therapeutic indication stated in the Summary of Product Characteristics for dapoxetine hydrochloride, patients will be candidates for enrollment if they have an intravaginal ejaculatory latency time of < two minutes
Description

In accordance with the therapeutic indication stated in the Summary of Product Characteristics for dapoxetine hydrochloride, patients will be candidates for enrollment if they have an intravaginal ejaculatory latency time of < two minutes

Data type

boolean

Alias
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C1709515
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
CL335836
UMLS CUI 2011AA
C0970823
UMLS CUI 2011AA
C0442122
SNOMED CT 2011_0131
264049007
UMLS CUI 2011AA
C0013746
SNOMED CT 2011_0131
40335009
UMLS CUI 2011AA
C0205275
SNOMED CT 2011_0131
44104002
UMLS CUI 2011AA
C0040223
SNOMED CT 2011_0131
410670007
LOINC Version 232
MTHU009151
Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes
Description

Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes

Data type

boolean

Alias
UMLS CUI 2011AA
C0205322
UMLS CUI 2011AA
C2945760
SNOMED CT 2011_0131
255227004
UMLS CUI 2011AA
C0013746
SNOMED CT 2011_0131
40335009
UMLS CUI 2011AA
C0547040
SNOMED CT 2011_0131
255605001
UMLS CUI 2011AA
C0036864
SNOMED CT 2011_0131
363903009
UMLS CUI 2011AA
C1292856
SNOMED CT 2011_0131
122545008
Marked personal distress or interpersonal difficulty as a consequence of premature ejaculation
Description

Marked personal distress or interpersonal difficulty as a consequence of premature ejaculation

Data type

boolean

Alias
UMLS CUI 2011AA
C1706089
UMLS CUI 2011AA
C0681884
UMLS CUI 2011AA
C0231303
SNOMED CT 2011_0131
69328002
MedDRA 14.1
10013487
UMLS CUI 2011AA
C0814588
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0033038
SNOMED CT 2011_0131
44001008
MedDRA 14.1
10036596
ICD-10-CM Version 2010
F52.4
ICD-9-CM Version 2011
302.75
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Poor control over ejaculation
Description

Poor control over ejaculation

Data type

boolean

Alias
UMLS CUI 2011AA
C2700379
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C0013746
SNOMED CT 2011_0131
40335009
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
In accordance with the contraindications, special warnings and precautions for use as stated in the Summary of Product Characteristics for dapoxetine hydrochloride, patients will be excluded from treatment if they have hypersensitivity to dapoxetine hydrochloride or to any of the excipients
Description

In accordance with the contraindications, special warnings and precautions for use as stated in the Summary of Product Characteristics for dapoxetine hydrochloride, patients will be excluded from treatment if they have hypersensitivity to dapoxetine hydrochloride or to any of the excipients

Data type

boolean

Alias
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C1709515
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0970823
UMLS CUI 2011AA
C0015237
SNOMED CT 2011_0131
360215002
Significant pathological cardiac conditions such as: heart failure (New York Heart Association [NYHA] class II-IV), conduction abnormalities (second or third degree atrioventicular (AV) block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease, or significant valvular disease
Description

Significant pathological cardiac conditions such as: heart failure (New York Heart Association [NYHA] class II-IV), conduction abnormalities (second or third degree atrioventicular (AV) block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease, or significant valvular disease

Data type

boolean

Alias
UMLS CUI 2011AA
C1522601
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0018801
SNOMED CT 2011_0131
155374007
MedDRA 14.1
10019279
ICD-9-CM Version 2011
428
CTCAE 1105E
E10124
UMLS CUI 2011AA
C1319794
SNOMED CT 2011_0131
421704003
MedDRA 14.1
10064080
UMLS CUI 2011AA
C1319795
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
UMLS CUI 2011AA
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
UMLS CUI 2011AA
C1842820
UMLS CUI 2011AA
C0264906
SNOMED CT 2011_0131
195042002
MedDRA 14.1
10003677
ICD-10-CM Version 2010
I44.1
UMLS CUI 2011AA
C0151517
SNOMED CT 2011_0131
27885002
MedDRA 14.1
10003673
ICD-10-CM Version 2010
I44.2
ICD-9-CM Version 2011
426.0
CTCAE 1105E
E10093
UMLS CUI 2011AA
C0037052
SNOMED CT 2011_0131
36083008
MedDRA 14.1
10040639
ICD-10-CM Version 2010
I49.5
CTCAE 1105E
E10202
UMLS CUI 2011AA
C0151744
SNOMED CT 2011_0131
414795007, 414545008
MedDRA 14.1
10028600
LOINC Version 232
MTHU024507
ICD-10-CM Version 2010
I20-I25
ICD-9-CM Version 2011
410-414.99
UMLS CUI 2011AA
C0026265
SNOMED CT 2011_0131
11851006
MedDRA 14.1
10061532
ICD-9-CM Version 2011
424.0
CTCAE 1105E
E10134
Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing treatment with an MAOI
Description

Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing treatment with an MAOI

Data type

boolean

Alias
UMLS CUI 2011AA
C1707479
UMLS CUI 2011AA
C1444662
SNOMED CT 2011_0131
410546004
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0026457
Concomitant treatment with thioridazine, concomitant treatment with serotonin reuptake inhibitors (selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], tricyclic antidepressants [TCAs)] or other medicinal/herbal products with serotonergic effects (for example, L-tryptophan, triptans, tramadol, linezolid, lithium, St. John's Wort (Hypericum perforatum)
Description

Concomitant treatment with thioridazine, concomitant treatment with serotonin reuptake inhibitors (selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], tricyclic antidepressants [TCAs)] or other medicinal/herbal products with serotonergic effects (for example, L-tryptophan, triptans, tramadol, linezolid, lithium, St. John's Wort (Hypericum perforatum)

Data type

boolean

Alias
UMLS CUI 2011AA
C1707479
UMLS CUI 2011AA
C0039943
SNOMED CT 2011_0131
33588000
LOINC Version 232
MTHU003228
UMLS CUI 2011AA
C2911696
UMLS CUI 2011AA
C0360105
SNOMED CT 2011_0131
349854005
UMLS CUI 2011AA
C1579361
UMLS CUI 2011AA
C0003290
SNOMED CT 2011_0131
373253007
LOINC Version 232
MTHU001920
UMLS CUI 2011AA
C0041249
SNOMED CT 2011_0131
108952000
LOINC Version 232
MTHU004124
UMLS CUI 2011AA
C1567966
UMLS CUI 2011AA
C0040610
SNOMED CT 2011_0131
108507005
LOINC Version 232
MTHU003394
UMLS CUI 2011AA
C0663241
SNOMED CT 2011_0131
125695009
LOINC Version 232
MTHU013614
UMLS CUI 2011AA
C0023870
SNOMED CT 2011_0131
85899009
LOINC Version 232
MTHU004197
UMLS CUI 2011AA
C0936242
SNOMED CT 2011_0131
51621002
Concomitant treatment of potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazadone, nelfinavir, atazanavir, etc.
Description

Concomitant treatment of potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazadone, nelfinavir, atazanavir, etc.

Data type

boolean

Alias
UMLS CUI 2011AA
C1707479
UMLS CUI 2011AA
C1142644
SNOMED CT 2011_0131
422741004
UMLS CUI 2011AA
C0243077
UMLS CUI 2011AA
C0022625
SNOMED CT 2011_0131
387216007
LOINC Version 232
MTHU002299
UMLS CUI 2011AA
C0064113
SNOMED CT 2011_0131
387532006
LOINC Version 232
MTHU002298
UMLS CUI 2011AA
C0292818
SNOMED CT 2011_0131
386896009
LOINC Version 232
MTHU013855
UMLS CUI 2011AA
C0286738
SNOMED CT 2011_0131
108700005
LOINC Version 232
MTHU008513
UMLS CUI 2011AA
C1452484
SNOMED CT 2011_0131
395260006
LOINC Version 232
MTHU016681
UMLS CUI 2011AA
C0068485
SNOMED CT 2011_0131
108435006
LOINC Version 232
MTHU003461
UMLS CUI 2011AA
C0525005
SNOMED CT 2011_0131
108706004
LOINC Version 232
MTHU013848
UMLS CUI 2011AA
C1145759
SNOMED CT 2011_0131
413591007
LOINC Version 232
MTHU018644
Moderate and severe hepatic impairment
Description

Moderate and severe hepatic impairment

Data type

boolean

Alias
UMLS CUI 2011AA
C1881878
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0948807
MedDRA 14.1
10052254
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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 64 Years
Item
age 18 Years to 64 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
In accordance with the therapeutic indication stated in the Summary of Product Characteristics for dapoxetine hydrochloride, patients will be candidates for enrollment if they have an intravaginal ejaculatory latency time of < two minutes
Item
In accordance with the therapeutic indication stated in the Summary of Product Characteristics for dapoxetine hydrochloride, patients will be candidates for enrollment if they have an intravaginal ejaculatory latency time of < two minutes
boolean
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C1709515 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
CL335836 (UMLS CUI 2011AA)
C0970823 (UMLS CUI 2011AA)
C0442122 (UMLS CUI 2011AA)
264049007 (SNOMED CT 2011_0131)
C0013746 (UMLS CUI 2011AA)
40335009 (SNOMED CT 2011_0131)
C0205275 (UMLS CUI 2011AA)
44104002 (SNOMED CT 2011_0131)
C0040223 (UMLS CUI 2011AA)
410670007 (SNOMED CT 2011_0131)
MTHU009151 (LOINC Version 232)
Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes
Item
Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes
boolean
C0205322 (UMLS CUI 2011AA)
C2945760 (UMLS CUI 2011AA)
255227004 (SNOMED CT 2011_0131)
C0013746 (UMLS CUI 2011AA)
40335009 (SNOMED CT 2011_0131)
C0547040 (UMLS CUI 2011AA)
255605001 (SNOMED CT 2011_0131)
C0036864 (UMLS CUI 2011AA)
363903009 (SNOMED CT 2011_0131)
C1292856 (UMLS CUI 2011AA)
122545008 (SNOMED CT 2011_0131)
Marked personal distress or interpersonal difficulty as a consequence of premature ejaculation
Item
Marked personal distress or interpersonal difficulty as a consequence of premature ejaculation
boolean
C1706089 (UMLS CUI 2011AA)
C0681884 (UMLS CUI 2011AA)
C0231303 (UMLS CUI 2011AA)
69328002 (SNOMED CT 2011_0131)
10013487 (MedDRA 14.1)
C0814588 (UMLS CUI 2011AA)
CL420107 (UMLS CUI 2011AA)
C0033038 (UMLS CUI 2011AA)
44001008 (SNOMED CT 2011_0131)
10036596 (MedDRA 14.1)
F52.4 (ICD-10-CM Version 2010)
302.75 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Poor control over ejaculation
Item
Poor control over ejaculation
boolean
C2700379 (UMLS CUI 2011AA)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0013746 (UMLS CUI 2011AA)
40335009 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
In accordance with the contraindications, special warnings and precautions for use as stated in the Summary of Product Characteristics for dapoxetine hydrochloride, patients will be excluded from treatment if they have hypersensitivity to dapoxetine hydrochloride or to any of the excipients
Item
In accordance with the contraindications, special warnings and precautions for use as stated in the Summary of Product Characteristics for dapoxetine hydrochloride, patients will be excluded from treatment if they have hypersensitivity to dapoxetine hydrochloride or to any of the excipients
boolean
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C1709515 (UMLS CUI 2011AA)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0970823 (UMLS CUI 2011AA)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
Significant pathological cardiac conditions such as: heart failure (New York Heart Association [NYHA] class II-IV), conduction abnormalities (second or third degree atrioventicular (AV) block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease, or significant valvular disease
Item
Significant pathological cardiac conditions such as: heart failure (New York Heart Association [NYHA] class II-IV), conduction abnormalities (second or third degree atrioventicular (AV) block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease, or significant valvular disease
boolean
C1522601 (UMLS CUI 2011AA)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C1319794 (UMLS CUI 2011AA)
421704003 (SNOMED CT 2011_0131)
10064080 (MedDRA 14.1)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
C1842820 (UMLS CUI 2011AA)
C0264906 (UMLS CUI 2011AA)
195042002 (SNOMED CT 2011_0131)
10003677 (MedDRA 14.1)
I44.1 (ICD-10-CM Version 2010)
C0151517 (UMLS CUI 2011AA)
27885002 (SNOMED CT 2011_0131)
10003673 (MedDRA 14.1)
I44.2 (ICD-10-CM Version 2010)
426.0 (ICD-9-CM Version 2011)
E10093 (CTCAE 1105E)
C0037052 (UMLS CUI 2011AA)
36083008 (SNOMED CT 2011_0131)
10040639 (MedDRA 14.1)
I49.5 (ICD-10-CM Version 2010)
E10202 (CTCAE 1105E)
C0151744 (UMLS CUI 2011AA)
414795007, 414545008 (SNOMED CT 2011_0131)
10028600 (MedDRA 14.1)
MTHU024507 (LOINC Version 232)
I20-I25 (ICD-10-CM Version 2010)
410-414.99 (ICD-9-CM Version 2011)
C0026265 (UMLS CUI 2011AA)
11851006 (SNOMED CT 2011_0131)
10061532 (MedDRA 14.1)
424.0 (ICD-9-CM Version 2011)
E10134 (CTCAE 1105E)
Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing treatment with an MAOI
Item
Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing treatment with an MAOI
boolean
C1707479 (UMLS CUI 2011AA)
C1444662 (UMLS CUI 2011AA)
410546004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0026457 (UMLS CUI 2011AA)
Concomitant treatment with thioridazine, concomitant treatment with serotonin reuptake inhibitors (selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], tricyclic antidepressants [TCAs)] or other medicinal/herbal products with serotonergic effects (for example, L-tryptophan, triptans, tramadol, linezolid, lithium, St. John's Wort (Hypericum perforatum)
Item
Concomitant treatment with thioridazine, concomitant treatment with serotonin reuptake inhibitors (selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], tricyclic antidepressants [TCAs)] or other medicinal/herbal products with serotonergic effects (for example, L-tryptophan, triptans, tramadol, linezolid, lithium, St. John's Wort (Hypericum perforatum)
boolean
C1707479 (UMLS CUI 2011AA)
C0039943 (UMLS CUI 2011AA)
33588000 (SNOMED CT 2011_0131)
MTHU003228 (LOINC Version 232)
C2911696 (UMLS CUI 2011AA)
C0360105 (UMLS CUI 2011AA)
349854005 (SNOMED CT 2011_0131)
C1579361 (UMLS CUI 2011AA)
C0003290 (UMLS CUI 2011AA)
373253007 (SNOMED CT 2011_0131)
MTHU001920 (LOINC Version 232)
C0041249 (UMLS CUI 2011AA)
108952000 (SNOMED CT 2011_0131)
MTHU004124 (LOINC Version 232)
C1567966 (UMLS CUI 2011AA)
C0040610 (UMLS CUI 2011AA)
108507005 (SNOMED CT 2011_0131)
MTHU003394 (LOINC Version 232)
C0663241 (UMLS CUI 2011AA)
125695009 (SNOMED CT 2011_0131)
MTHU013614 (LOINC Version 232)
C0023870 (UMLS CUI 2011AA)
85899009 (SNOMED CT 2011_0131)
MTHU004197 (LOINC Version 232)
C0936242 (UMLS CUI 2011AA)
51621002 (SNOMED CT 2011_0131)
Concomitant treatment of potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazadone, nelfinavir, atazanavir, etc.
Item
Concomitant treatment of potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazadone, nelfinavir, atazanavir, etc.
boolean
C1707479 (UMLS CUI 2011AA)
C1142644 (UMLS CUI 2011AA)
422741004 (SNOMED CT 2011_0131)
C0243077 (UMLS CUI 2011AA)
C0022625 (UMLS CUI 2011AA)
387216007 (SNOMED CT 2011_0131)
MTHU002299 (LOINC Version 232)
C0064113 (UMLS CUI 2011AA)
387532006 (SNOMED CT 2011_0131)
MTHU002298 (LOINC Version 232)
C0292818 (UMLS CUI 2011AA)
386896009 (SNOMED CT 2011_0131)
MTHU013855 (LOINC Version 232)
C0286738 (UMLS CUI 2011AA)
108700005 (SNOMED CT 2011_0131)
MTHU008513 (LOINC Version 232)
C1452484 (UMLS CUI 2011AA)
395260006 (SNOMED CT 2011_0131)
MTHU016681 (LOINC Version 232)
C0068485 (UMLS CUI 2011AA)
108435006 (SNOMED CT 2011_0131)
MTHU003461 (LOINC Version 232)
C0525005 (UMLS CUI 2011AA)
108706004 (SNOMED CT 2011_0131)
MTHU013848 (LOINC Version 232)
C1145759 (UMLS CUI 2011AA)
413591007 (SNOMED CT 2011_0131)
MTHU018644 (LOINC Version 232)
Moderate and severe hepatic impairment
Item
Moderate and severe hepatic impairment
boolean
C1881878 (UMLS CUI 2011AA)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0948807 (UMLS CUI 2011AA)
10052254 (MedDRA 14.1)
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