ID

24793

Descrição

Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury; ODM derived from: https://clinicaltrials.gov/show/NCT00597818

Link

https://clinicaltrials.gov/show/NCT00597818

Palavras-chave

Versões (2)
  1. 17/08/2017 17/08/2017 -
  2. 17/08/2017 17/08/2017 -
Transferido a

17 août 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility NSAID-induced Gastroduodenal Injury NCT00597818

Inglês

Eligibility NSAID-induced Gastroduodenal Injury NCT00597818

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is more than 40 and less than 70 years of age.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patient has confirmed osteoarthritis (oa) and/or rheumatoid arthritis (ra) and could benefit from nsaid therapy.
Descrição

Osteoarthritis | Rheumatoid Arthritis | Benefit Due to NSAID treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029408
UMLS CUI [2]
C0003873
UMLS CUI [3,1]
C0814225
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0746950
no current gastrointestinal h. pylori infection.
Descrição

Helicobacter pylori gastrointestinal tract infection Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0585625
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
known allergy or hypersensitivity to nsaids, or has any other contraindicated condition(s) to nsaid therapy.
Descrição

Allergy to nonsteroidal anti-inflammatory agents | Medical contraindication NSAID treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0746949
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0746950
patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the screening visit, or has had a bowel resection at any time.
Descrição

Gastrointestinal Surgical Procedure | Abdominal operation | Bowel resection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0524722
UMLS CUI [2]
C0198482
UMLS CUI [3]
C0741614
medical history includes prior or active gi complications and/or disorders, including but not limited to barrett's esophagus, erosive esophagitis, esophageal stricture or ring, gastric obstruction, irritable bowel syndrome (ibs), or inflammatory bowel disease (ibd).
Descrição

Gastrointestinal complication | Gastrointestinal Diseases | Barrett Esophagus | Erosive esophagitis | Esophageal Stenosis | Esophageal ring | Obstruction gastric | Irritable Bowel Syndrome | Inflammatory Bowel Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0161819
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0004763
UMLS CUI [4]
C0267055
UMLS CUI [5]
C0014866
UMLS CUI [6]
C0267081
UMLS CUI [7]
C0149700
UMLS CUI [8]
C0022104
UMLS CUI [9]
C0021390
active symptomatic peptic ulcer disease or gi bleeding.
Descrição

Peptic Ulcer Symptomatic | Gastrointestinal Hemorrhage

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030920
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0017181
patient has received cobiprostone (spi-8811; ru-8811) or amitiza (lubiprostone, spi-0211, or ru-0211) at any time prior to participation in this study.
Descrição

cobiprostone | SPI-8811 | Amitiza | lubiprostone | SPI 0211 | RU 0211

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2699393
UMLS CUI [2]
C2703103
UMLS CUI [3]
C1699150
UMLS CUI [4]
C1684405
UMLS CUI [5]
C1681887
UMLS CUI [6]
C1683269
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Similar models

Eligibility NSAID-induced Gastroduodenal Injury NCT00597818

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient is more than 40 and less than 70 years of age.
boolean
C0001779 (UMLS CUI [1])
Osteoarthritis | Rheumatoid Arthritis | Benefit Due to NSAID treatment
Item
patient has confirmed osteoarthritis (oa) and/or rheumatoid arthritis (ra) and could benefit from nsaid therapy.
boolean
C0029408 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0814225 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0746950 (UMLS CUI [3,3])
Helicobacter pylori gastrointestinal tract infection Absent
Item
no current gastrointestinal h. pylori infection.
boolean
C0585625 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Allergy to nonsteroidal anti-inflammatory agents | Medical contraindication NSAID treatment
Item
known allergy or hypersensitivity to nsaids, or has any other contraindicated condition(s) to nsaid therapy.
boolean
C0746949 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0746950 (UMLS CUI [2,2])
Gastrointestinal Surgical Procedure | Abdominal operation | Bowel resection
Item
patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the screening visit, or has had a bowel resection at any time.
boolean
C0524722 (UMLS CUI [1])
C0198482 (UMLS CUI [2])
C0741614 (UMLS CUI [3])
Gastrointestinal complication | Gastrointestinal Diseases | Barrett Esophagus | Erosive esophagitis | Esophageal Stenosis | Esophageal ring | Obstruction gastric | Irritable Bowel Syndrome | Inflammatory Bowel Disease
Item
medical history includes prior or active gi complications and/or disorders, including but not limited to barrett's esophagus, erosive esophagitis, esophageal stricture or ring, gastric obstruction, irritable bowel syndrome (ibs), or inflammatory bowel disease (ibd).
boolean
C0161819 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0004763 (UMLS CUI [3])
C0267055 (UMLS CUI [4])
C0014866 (UMLS CUI [5])
C0267081 (UMLS CUI [6])
C0149700 (UMLS CUI [7])
C0022104 (UMLS CUI [8])
C0021390 (UMLS CUI [9])
Peptic Ulcer Symptomatic | Gastrointestinal Hemorrhage
Item
active symptomatic peptic ulcer disease or gi bleeding.
boolean
C0030920 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0017181 (UMLS CUI [2])
cobiprostone | SPI-8811 | Amitiza | lubiprostone | SPI 0211 | RU 0211
Item
patient has received cobiprostone (spi-8811; ru-8811) or amitiza (lubiprostone, spi-0211, or ru-0211) at any time prior to participation in this study.
boolean
C2699393 (UMLS CUI [1])
C2703103 (UMLS CUI [2])
C1699150 (UMLS CUI [3])
C1684405 (UMLS CUI [4])
C1681887 (UMLS CUI [5])
C1683269 (UMLS CUI [6])
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