ID

18600

Description

A Study on Efficacy and Safety of Topiramate OROS Controlled-Release in Obese, Type 2 Diabetic Subjects Managed With Diet or Metformin; ODM derived from: https://clinicaltrials.gov/show/NCT00231647

Link

https://clinicaltrials.gov/show/NCT00231647

Keywords

Versions (1)
  1. 11/11/16 11/11/16 -
Uploaded on

November 11, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Obesity NCT00231647

English

Eligibility Obesity NCT00231647

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00231647
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
body mass index (bmi) >= 27 kg/m^2 and <50 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
diagnosis of type 2 diabetes, managed with either diet alone or combined with monotherapy treatment with metformin
Description

Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0025598
stable weight for at least 2 months
Description

Stable body weight Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0517386
UMLS CUI [1,2]
C0449238
female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test).
Description

Postmenopausal state | Female Sterilization | Sexual Abstinence | Contraceptive methods | Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0036899
UMLS CUI [4]
C0700589
UMLS CUI [5]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindication or hypersensitivity to topiramate
Description

Medical contraindication topiramate | Hypersensitivity topiramate

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0076829
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0076829
exposure to any other experimental drug or device within past 90 days
Description

Investigational New Drugs Exposure to | Investigational Medical Device Exposure to

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332157
UMLS CUI [2,1]
C2346570
UMLS CUI [2,2]
C0332157
established diagnosis of type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
history of severe or recurrent hypoglycemic episodes prior to study entry
Description

Hypoglycaemic episode Quantity Severe | Recurrent hypoglycemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0745153
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0205082
UMLS CUI [2]
C1846288
taking oral antidiabetic medications other than metformin
Description

Antidiabetics Oral | Metformin

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0025598
treatment with insulin within 4 months
Description

Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0021641
significant liver, kidney or cardiovascular diseases.
Description

Liver diseases Significant | Kidney Diseases Significant | Cardiovascular Diseases Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0750502
UMLS CUI [3,1]
C0007222
UMLS CUI [3,2]
C0750502
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Similar models

Eligibility Obesity NCT00231647

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00231647
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index
Item
body mass index (bmi) >= 27 kg/m^2 and <50 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Metformin
Item
diagnosis of type 2 diabetes, managed with either diet alone or combined with monotherapy treatment with metformin
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
Stable body weight Duration
Item
stable weight for at least 2 months
boolean
C0517386 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Postmenopausal state | Female Sterilization | Sexual Abstinence | Contraceptive methods | Pregnancy test negative
Item
female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test).
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0036899 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
C0427780 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Medical contraindication topiramate | Hypersensitivity topiramate
Item
contraindication or hypersensitivity to topiramate
boolean
C1301624 (UMLS CUI [1,1])
C0076829 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0076829 (UMLS CUI [2,2])
Investigational New Drugs Exposure to | Investigational Medical Device Exposure to
Item
exposure to any other experimental drug or device within past 90 days
boolean
C0013230 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C2346570 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
Diabetes Mellitus, Insulin-Dependent
Item
established diagnosis of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Hypoglycaemic episode Quantity Severe | Recurrent hypoglycemia
Item
history of severe or recurrent hypoglycemic episodes prior to study entry
boolean
C0745153 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C1846288 (UMLS CUI [2])
Antidiabetics Oral | Metformin
Item
taking oral antidiabetic medications other than metformin
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2])
Insulin
Item
treatment with insulin within 4 months
boolean
C0021641 (UMLS CUI [1])
Liver diseases Significant | Kidney Diseases Significant | Cardiovascular Diseases Significant
Item
significant liver, kidney or cardiovascular diseases.
boolean
C0023895 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
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