Phase
Condition
Inflammatory Bowel Disease
Crohn's Disease
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female Chinese patients aged ≥18 to ≤ 70 years
Newly diagnosed or recurrent active ulcerative colitis (A gold standard for thediagnosis of ulcerative colitis is not available. The diagnosis should be establishedby a combination of medical history, clinical evaluation, and typical endoscopic andhistological findings. An infective cause should be excluded. Where there is doubtabout the diagnosis, endoscopic and histological confirmation is necessary after aninterval.)
Extent of colonic involvement and endoscopy subscore of Mayo score as confirmed bycolonoscopy (it should be done within 15 days prior to randomization)
Total Mayo score of at least 4 and a score of ≥ 2 for colonoscopy
Oralthe stability dose of 5-ASA medicine 14days.
Negative stool test at screening to rule out parasites and bacterial pathogens
The patient is compliant with Patient Daily Diary
Women with childbearing potential must have an efficacious contraception as judged bythe investigators and must have a negative pregnancy test result at screening
Signed Informed Consent obtained before any trial-related procedures.
Exclusion
Exclusion Criteria:
Severe/fulminant ulcerative colitis or toxic dilatation of the colon
Prior bowel resection surgery
Known infection of human immunodeficiency virus (HIV), Hepatitis B virus (HBV) orHepatitis C virus (HCV) (Note active Hepatitis B patients should be excluded from thestudy e.g. HBeAg positive or HBV DNA positive, with the exception for inactive HBsAgcarrier)
Take the following treatment:
Any 5-ASA enema or suppository therapy during the 14 days prior to screening
Corticosteroids (oral, intravenous, intramuscular, or rectal ) within 7 daysprior to screening
Any immunomodulating/suppressive agents during the 60 days prior to screening
Any Anti-TNF therapy during the 6 months prior to screening
Antibiotics (metronidazole and ciprofloxacin) within 7 days prior to screening
Loperamide, nicotine patch and mucilages within 7 days prior to screening
Traditional Chinese Medicine for the treatment of UC (any pharmaceutical form)within 7 days prior to screening
Patients allergic to 5-ASA and derivative, any of the excipients, aspirin, orsalicylates
Known significant hepatic function abnormalities, defined as the values of serum ALTor AST are equal to or more than twice of the upper limit of normal value
Women who are planning or actual pregnancy or lactation during study period
Alcohol addiction (>40 g of alcohol/day equivalent to >1 L of beer/day, 0.5 L ofwine/day, or 6 glasses (2 centiliter, cl) of liquor/day)
Drug addiction confirmed by patients' medical history
History of disease that would interfere with their participation in the trial,including malignant diseases, bleeding disorders, active gastric or active duodenalulcers, autoimmune diseases, and mental or emotional disorder
Patient participating or having participated in another clinical study 30 days priorto screening
Patient who are unlikely to comply with the protocol as judged by the investigator
Patients who are unable to fill in the Patient Daily Diary or follow data-capturingprocedures
Patients with one or more of the diseases: bacillary dysentery, amebic dysentery,chronic schistosomiasis, intestinal tuberculosis and Crohn's disease
Patients with any other disease or condition which might interfere with studyassessment as judged by the investigator.
Study Design
Connect with a study center
Xijing Digestive Disease
Xi'an, Shaanxi 710032
ChinaActive - Recruiting
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