Phase
Condition
Colic
Bowel Dysfunction
Ulcerative Colitis
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria
Males and females ≥ 18 years old, including women who are not pregnant or lactating atthe time of enrollment.
Subjects should have a CDAI score ≥ 150 at week 0
Able to swallow tablets
Are capable of providing written informed consent and obtained at the time ofenrollment
Willing to adhere to the study visit schedule and other protocol requirements.
Exclusion
Exclusion Criteria:
Bacterial,viral or other microbial infection(including HIV)
Needing orally administered corticosteroids for the treatment of other diseases.Inhaled or dermatologic preparations are acceptable.
Previous or current use of infliximab. current use of prescription doses orchronic/frequent use of NSAIDs
Treatment with narcotic pain medications. (Anti-diarrheal agents such as loperamideand diphenoxylate are permitted)
History of pancreatitis, except for subjects with a known but removed cause(such asgallstone pancreatitis)
History of abnormal liver function tests, including AST or ALT >1.5 times upper limitof normal, alkaline phosphatase >2 times upper limit of normal, total bilirubin >2.5mg/dL at screening (or within the previous 6 months, if known)
History of malignancy
Women who are pregnant or lactating at the time of enrollment, or who intend to beduring the study period.
Participation in other clinical trial within the past 6 months
Study Design
Study Description
Connect with a study center
General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China
Nanjing, Jiangsu 210000
ChinaActive - Recruiting

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