ID

231

Description

ODM derived from http://clinicaltrials.gov/show/NCT00275379

Link

http://clinicaltrials.gov/show/NCT00275379

Keywords

Versions (2)
  1. 3/6/12 3/6/12 -
  2. 6/7/17 6/7/17 - Martin Dugas
Uploaded on

March 6, 2012

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility NCT00275379 Cystitis, Interstitial

German English

Eligibility

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

Inclusion Criteria

Age 18 Years and older
Description

Age

Data type

boolean

Subjects seeking medical treatment for symptoms consistent with IC that have been ongoing for > 9 months or seeking medical treatment for a previous documented diagnosis of IC
Description

medical treatment for IC

Data type

boolean

Subjects who are not surgically sterile or postmenopausal (amenorrheic > 12 months) must agree and commit to the use of a medically acceptable, highly-effective (i.e. double-barrier or IUD), non-hormonal form of birth control during the study and for 30 days after the last dose of test
Description

agreement to birth control

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Use of herbal supplements (except for a daily multivitamin/mineral supplement not containing herbal components)
Description

Use of herbal supplements

Data type

boolean

History of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) with less than 5 years documentation of a disease-free state
Description

History of cancer

Data type

boolean

Vaginitis or vaginal infection within 1 month before randomization
Description

Vaginitis or vaginal infection

Data type

boolean

Medical Concepts
Description

Medical Concepts

Age
Description

Age

Data type

integer

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
397669002
Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
medical treatment approach
Description

medical treatment method

Data type

string

Alias
UMLS CUI
C0679624
Interstitial Cystitis
Description

IC

Data type

string

Alias
UMLS CUI
C0282488
SNOMED CT 2010_0731
197834003
MedDRA 13.1
10011796
Contraceptive method: female sterilization
Description

Female Sterilizations

Data type

string

Alias
UMLS CUI
C0015787
SNOMED CT 2010_0731
169549004
MedDRA 13.1
10056199
Postmenopause
Description

Postmenopause

Data type

string

Alias
UMLS CUI
C0206159
MedDRA 13.1
10051775
Absence of menstruation
Description

Amenorrhea

Data type

string

Alias
UMLS CUI
C0002453
SNOMED CT 2010_0731
14302001
MedDRA 13.1
10001928
ICD-10-CM Version 2010
N91.2
ICD-9-CM Version 2011
626.0
Informed Consent
Description

Informed Consent

Data type

string

Alias
UMLS CUI
C0021430
Contraception, Birth control
Description

Contraception

Data type

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Barrier contraception method
Description

Contraception, Barrier

Data type

string

Alias
UMLS CUI
C0004764
SNOMED CT 2010_0731
225370004
Intrauterine contraceptive device
Description

IUD

Data type

string

Alias
UMLS CUI
C0021900
SNOMED CT 2010_0731
268460000
MedDRA 13.1
10022745
Herbal supplement
Description

Herbal supplement

Data type

string

Alias
UMLS CUI
C1504473
MedDRA 13.1
10063340
Malignant Neoplasms
Description

Cancer

Data type

string

Alias
UMLS CUI
C0006826
SNOMED CT 2010_0731
363346000
MedDRA 13.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Basal cell carcinoma
Description

Basal cell carcinoma

Data type

string

Alias
UMLS CUI
C0007117
SNOMED CT 2010_0731
1338007
MedDRA 13.1
10004146
Squamous cell carcinoma
Description

Squamous cell carcinoma

Data type

string

Alias
UMLS CUI
C0007137
SNOMED CT 2010_0731
28899001
MedDRA 13.1
10041823
Carcinoma of cervix
Description

Cervix carcinoma

Data type

string

Alias
UMLS CUI
C0302592
SNOMED CT 2010_0731
285432005
MedDRA 13.1
10008342
Inflammation of vagina
Description

Vaginitis

Data type

string

Alias
UMLS CUI
C0042267
SNOMED CT 2010_0731
30800001
MedDRA 13.1
10046950
CTCAE Version 4.03
E13270
Vaginal infection
Description

Infective vaginitis

Data type

string

Alias
UMLS CUI
C0404521
SNOMED CT 2010_0731
237091009
MedDRA 13.1
10046914
ICD-10-CM Version 2010
N76.0
CTCAE Version 4.03
E11624
Random Allocation
Description

Randomization

Data type

string

Alias
UMLS CUI
C0034656
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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
Age
Item
Age 18 Years and older
boolean
medical treatment for IC
Item
Subjects seeking medical treatment for symptoms consistent with IC that have been ongoing for > 9 months or seeking medical treatment for a previous documented diagnosis of IC
boolean
agreement to birth control
Item
Subjects who are not surgically sterile or postmenopausal (amenorrheic > 12 months) must agree and commit to the use of a medically acceptable, highly-effective (i.e. double-barrier or IUD), non-hormonal form of birth control during the study and for 30 days after the last dose of test
boolean
Item Group
Exclusion Criteria
Use of herbal supplements
Item
Use of herbal supplements (except for a daily multivitamin/mineral supplement not containing herbal components)
boolean
History of cancer
Item
History of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) with less than 5 years documentation of a disease-free state
boolean
Vaginitis or vaginal infection
Item
Vaginitis or vaginal infection within 1 month before randomization
boolean
Item Group
Medical Concepts
Age
Item
Age
integer
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
medical treatment method
Item
medical treatment approach
string
C0679624 (UMLS CUI)
IC
Item
Interstitial Cystitis
string
C0282488 (UMLS CUI)
197834003 (SNOMED CT 2010_0731)
10011796 (MedDRA 13.1)
Female Sterilizations
Item
Contraceptive method: female sterilization
string
C0015787 (UMLS CUI)
169549004 (SNOMED CT 2010_0731)
10056199 (MedDRA 13.1)
Postmenopause
Item
Postmenopause
string
C0206159 (UMLS CUI)
10051775 (MedDRA 13.1)
Amenorrhea
Item
Absence of menstruation
string
C0002453 (UMLS CUI)
14302001 (SNOMED CT 2010_0731)
10001928 (MedDRA 13.1)
N91.2 (ICD-10-CM Version 2010)
626.0 (ICD-9-CM Version 2011)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Contraception
Item
Contraception, Birth control
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Contraception, Barrier
Item
Barrier contraception method
string
C0004764 (UMLS CUI)
225370004 (SNOMED CT 2010_0731)
IUD
Item
Intrauterine contraceptive device
string
C0021900 (UMLS CUI)
268460000 (SNOMED CT 2010_0731)
10022745 (MedDRA 13.1)
Herbal supplement
Item
Herbal supplement
string
C1504473 (UMLS CUI)
10063340 (MedDRA 13.1)
Cancer
Item
Malignant Neoplasms
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Basal cell carcinoma
Item
Basal cell carcinoma
string
C0007117 (UMLS CUI)
1338007 (SNOMED CT 2010_0731)
10004146 (MedDRA 13.1)
Squamous cell carcinoma
Item
Squamous cell carcinoma
string
C0007137 (UMLS CUI)
28899001 (SNOMED CT 2010_0731)
10041823 (MedDRA 13.1)
Cervix carcinoma
Item
Carcinoma of cervix
string
C0302592 (UMLS CUI)
285432005 (SNOMED CT 2010_0731)
10008342 (MedDRA 13.1)
Vaginitis
Item
Inflammation of vagina
string
C0042267 (UMLS CUI)
30800001 (SNOMED CT 2010_0731)
10046950 (MedDRA 13.1)
E13270 (CTCAE Version 4.03)
Infective vaginitis
Item
Vaginal infection
string
C0404521 (UMLS CUI)
237091009 (SNOMED CT 2010_0731)
10046914 (MedDRA 13.1)
N76.0 (ICD-10-CM Version 2010)
E11624 (CTCAE Version 4.03)
Randomization
Item
Random Allocation
string
C0034656 (UMLS CUI)
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