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| Name | Class |
|---|---|
| Shanghai Tongji Hospital, Tongji University School of Medicine | OTHER |
| First Affiliated Hospital of Zhongshan Medical University | OTHER |
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The research aims to evaluate the efficacy and safety of that mesalazine with hydrocortisone sodium succinate for the induction of clinical remission during a 4-week double-blind treatment period in active UC (define as total Mayo score of greater than or equal to 4 and less than or equal to 10). A total of 528 patients will be randomly divided into three group, one will receive mesalazine 4g with hydrocortisone sodium succinate 100mg enema, and the other two group will respectively to receive mesalazine 4g and hydrocortisone sodium 100mg one times daily for 4 weeks. The end of the study for every patient is the improvement of main symptoms.The primary endpoint is the clinical remission after 2 and 4 weeks double-blind treatment, defined on the basis of a total Mayo score ≤ 2 points, with no subscore > 1 point. The secondary endpoint are endoscopic mucosal healing at week 2 and 4 of double-blind period, defined as an absolute subscore for endoscopy portion of the Mayo score of 0 point and the change from baseline in Quality of Life at week 4 of double-blind period based on the IBDQ.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesalazine with hydrocortisone sodium succinate | Experimental | Mesalazine(4g) with hydrocortisone sodium succinate (100mg ) enema |
|
| Mesalazine | Active Comparator | Mesalazine (4g)enema |
|
| Hydrocortisone sodium succinate | Active Comparator | Hydrocortisone sodium succinate (100mg ) enema |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesalazine | Drug | Mesalazine enema rectal administration at bedtime 4g/100 ml, once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of clinical remission | Clinical remission after 2 and 4 weeks double-blind treatment, defined on the basis of a total Mayo score ≤ 2 points, with no subscore > 1 point | 2 weeks, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of endoscopic mucosal healing | endoscopic mucosal healing at week 2 and 4 of double-blind period, defined as an absolute subscore for endoscopy portion of the Mayo score of 0 point | 2 weeks, 4 weeks |
| Change of quality of life based on the IBDQ |
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Inclusion Criteria:
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) or Hepatitis C virus (HCV) (Note active Hepatitis B patients should be excluded from the study e.g. HBeAg positive or HBV DNA positive, with the exception for inactive HBsAg carrier)
Take the following treatment:
Patients allergic to 5-ASA and derivative, any of the excipients, aspirin, or salicylates
Known significant hepatic function abnormalities, defined as the values of serum ALT or 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 of wine/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 duodenal ulcers, autoimmune diseases, and mental or emotional disorder
Patient participating or having participated in another clinical study 30 days prior to 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-capturing procedures
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 study assessment as judged by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jie Liang, professor | Contact | 86-029-85771535 | liangjie@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| jie Liang, professor | China,Shaanxi,Xi'an, Xijing Hospital of Digeetive Disease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Digestive Disease | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| hydrocortisone sodium succinate |
| Drug |
hydrocortisone sodium succinate rectal administration at bedtime 100mg/100 ml, once daily |
|
| Mesalazine with hydrocortisone sodium succinate | Drug | Mesalazine with hydrocortisone sodium succinate rectal administration at bedtime 4g,100mg/100 ml, once daily for induction of remission |
|
The change from baseline in Quality of Life at week 2 and 4 of double-blind period based on the IBDQ
| 2 weeks, 4 weeks |
| Change of mental health by Anxiety and Depression Assessment Scale | Assess mental health by Anxiety and Depression Assessment Scale | 2 weeks, 4 weeks |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D019804 | Mesalamine |
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
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