- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03110198
Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative Colitis
April 6, 2017 updated by: Jie Liang, Xijing Hospital of Digestive Diseases
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)
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
528
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jie Liang, Professor
- Phone Number: 86-029-85771535
- Email: liangjie@fmmu.edu.cn
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Recruiting
- Xijing Digestive Disease
-
Contact:
- Jie liang, professor
- Phone Number: 86-029-84771535
- Email: liangjie@fmmu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female Chinese patients aged ≥18 to ≤ 70 years
- 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.)
- Extent of colonic involvement and endoscopy subscore of Mayo score as confirmed by colonoscopy (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 by the investigators and must have a negative pregnancy test result at screening
- Signed Informed Consent obtained before any trial-related procedures.
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:
- Any 5-ASA enema or suppository therapy during the 14 days prior to screening
- Corticosteroids (oral, intravenous, intramuscular, or rectal ) within 7 days prior 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, 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mesalazine with hydrocortisone sodium succinate
Mesalazine(4g) with hydrocortisone sodium succinate (100mg ) enema
|
Mesalazine with hydrocortisone sodium succinate rectal administration at bedtime 4g,100mg/100 ml, once daily for induction of remission
|
Active Comparator: Mesalazine
Mesalazine (4g)enema
|
Mesalazine enema rectal administration at bedtime 4g/100 ml, once daily
|
Active Comparator: Hydrocortisone sodium succinate
Hydrocortisone sodium succinate (100mg ) enema
|
hydrocortisone sodium succinate rectal administration at bedtime 100mg/100 ml, once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of clinical remission
Time Frame: 2 weeks, 4 weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of endoscopic mucosal healing
Time Frame: 2 weeks, 4 weeks
|
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
Time Frame: 2 weeks, 4 weeks
|
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
Time Frame: 2 weeks, 4 weeks
|
Assess mental health by Anxiety and Depression Assessment Scale
|
2 weeks, 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: jie Liang, professor, China,Shaanxi,Xi'an, Xijing Hospital of Digeetive Disease
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2017
Primary Completion (Anticipated)
January 1, 2018
Study Completion (Anticipated)
March 1, 2018
Study Registration Dates
First Submitted
February 19, 2017
First Submitted That Met QC Criteria
April 6, 2017
First Posted (Actual)
April 12, 2017
Study Record Updates
Last Update Posted (Actual)
April 12, 2017
Last Update Submitted That Met QC Criteria
April 6, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Ulcer
- Colitis
- Colitis, Ulcerative
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Hydrocortisone
- Hydrocortisone 17-butyrate 21-propionate
- Hydrocortisone acetate
- Hydrocortisone hemisuccinate
- Mesalamine
Other Study ID Numbers
- KY20162063-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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