Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03110198
• Date of registration: 19/02/2017
• Prospective Registration: Yes
• Primary sponsor: Xijing Hospital of Digestive Diseases
• Public title: Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative Colitis
• Scientific title: A Randomized, Double-blind Study Investigating the Efficacy and Safety of Mesalazine With Hydrocortisone Sodium Succinate (100mg QD) Enema for 4-Week Treatment in Patients With Ulcerative Colitis (UC)
• Date of first enrolment: May 2017
• Target sample size: 528
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03110198
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

China

Contacts

• Name: jie Liang, professor
• Affiliation: China,Shaanxi,Xi'an, Xijing Hospital of Digeetive Disease

• Name: Jie liang, professor

• Name: jie Liang, professor

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female Chinese patients aged =18 to = 70 years

2. Newly diagnosed or recurrent active ulcerative colitis (A gold standard for the
diagnosis of ulcerative colitis is not available. The diagnosis should be established
by a combination of medical history, clinical evaluation, and typical endoscopic and
histological findings. An infective cause should be excluded. Where there is doubt
about the diagnosis, endoscopic and histological confirmation is necessary after an
interval.)

3. Extent of colonic involvement and endoscopy subscore of Mayo score as confirmed by
colonoscopy (it should be done within 15 days prior to randomization)

4. Total Mayo score of at least 4 and a score of = 2 for colonoscopy

5. Oralthe stability dose of 5-ASA medicine 14days.

6. Negative stool test at screening to rule out parasites and bacterial pathogens

7. The patient is compliant with Patient Daily Diary

8. Women with childbearing potential must have an efficacious contraception as judged by
the investigators and must have a negative pregnancy test result at screening

9. Signed Informed Consent obtained before any trial-related procedures.

Exclusion Criteria:

1. Severe/fulminant ulcerative colitis or toxic dilatation of the colon

2. Prior bowel resection surgery

3. 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)

4. Take the following treatment:

1. Any 5-ASA enema or suppository therapy during the 14 days prior to screening

2. Corticosteroids (oral, intravenous, intramuscular, or rectal ) within 7 days
prior to screening

3. Any immunomodulating/suppressive agents during the 60 days prior to screening

4. Any Anti-TNF therapy during the 6 months prior to screening

5. Antibiotics (metronidazole and ciprofloxacin) within 7 days prior to screening

6. Loperamide, nicotine patch and mucilages within 7 days prior to screening

7. Traditional Chinese Medicine for the treatment of UC (any pharmaceutical form)
within 7 days prior to screening

5. Patients allergic to 5-ASA and derivative, any of the excipients, aspirin, or
salicylates

6. 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

7. Women who are planning or actual pregnancy or lactation during study period

8. 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)

9. Drug addiction confirmed by patients' medical history

10. 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

11. Patient participating or having participated in another clinical study 30 days prior
to screening

12. Patient who are unlikely to comply with the protocol as judged by the investigator

13. Patients who are unable to fill in the Patient Daily Diary or follow data-capturing
procedures

14. Patients with one or more of the diseases: bacillary dysentery, amebic dysentery,
chronic schistosomiasis, intestinal tuberculosis and Crohn's disease

15. Patients with any other disease or condition which might interfere with study
assessment as judged by the investigator.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis, Unspecified

Intervention(s)

Drug: Mesalazine with hydrocortisone sodium succinate

Drug: Mesalazine

Drug: hydrocortisone sodium succinate

Primary Outcome(s)

Change of clinical remission [Time Frame: 2 weeks, 4 weeks]

Secondary Outcome(s)

Change of mental health by Anxiety and Depression Assessment Scale [Time Frame: 2 weeks, 4 weeks]

Change of quality of life based on the IBDQ [Time Frame: 2 weeks, 4 weeks]

Change of endoscopic mucosal healing [Time Frame: 2 weeks, 4 weeks]

Secondary ID(s)

KY20162063-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

First Affiliated Hospital of Zhongshan Medical University

Shanghai Tongji Hospital, Tongji University School of Medicine