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

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ClinicalTrials.gov Identifier: NCT03110198
Recruitment Status : Unknown
Verified April 2017 by Jie Liang, Xijing Hospital of Digestive Diseases.
Recruitment status was:  Recruiting
First Posted : April 12, 2017
Last Update Posted : April 12, 2017
Sponsor:
Collaborators:
Shanghai Tongji Hospital, Tongji University School of Medicine
First Affiliated Hospital of Zhongshan Medical University
Information provided by (Responsible Party):
Jie Liang, Xijing Hospital of Digestive Diseases

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis, Unspecified Drug: Mesalazine Drug: hydrocortisone sodium succinate Drug: Mesalazine with hydrocortisone sodium succinate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 528 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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)
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : March 2018


Arm Intervention/treatment
Experimental: Mesalazine with hydrocortisone sodium succinate
Mesalazine(4g) with hydrocortisone sodium succinate (100mg ) enema
Drug: Mesalazine with hydrocortisone sodium succinate
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
Drug: Mesalazine
Mesalazine enema rectal administration at bedtime 4g/100 ml, once daily

Active Comparator: Hydrocortisone sodium succinate
Hydrocortisone sodium succinate (100mg ) enema
Drug: hydrocortisone sodium succinate
hydrocortisone sodium succinate rectal administration at bedtime 100mg/100 ml, once daily




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110198


Contacts
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Contact: jie Liang, professor 86-029-85771535 liangjie@fmmu.edu.cn

Locations
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China, Shaanxi
Xijing Digestive Disease Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Jie liang, professor    86-029-84771535    liangjie@fmmu.edu.cn   
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases
Shanghai Tongji Hospital, Tongji University School of Medicine
First Affiliated Hospital of Zhongshan Medical University
Investigators
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Principal Investigator: jie Liang, professor China,Shaanxi,Xi'an, Xijing Hospital of Digeetive Disease

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Responsible Party: Jie Liang, Associated professor, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT03110198     History of Changes
Other Study ID Numbers: KY20162063-1
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jie Liang, Xijing Hospital of Digestive Diseases:
Mesalazine
Ulcerative Colitis(UC)
Enema
Additional relevant MeSH terms:
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Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Mesalamine
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents