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

NCT03110198 | Unknown Phase 4

• 1 other identifier: KY20162063-1
• Study Type: interventional
• Target: 528
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis, Unspecified

Keywords

Mesalazine; Ulcerative Colitis(UC); Enema

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change of endoscopic mucosal healing

  2 weeks, 4 weeks

• Change of quality of life based on the IBDQ

  2 weeks, 4 weeks

• Change of mental health by Anxiety and Depression Assessment Scale

  2 weeks, 4 weeks

Study Arms (3)

Mesalazine with hydrocortisone sodium succinate

EXPERIMENTAL

Mesalazine（4g） with hydrocortisone sodium succinate (100mg ) enema

Drug: Mesalazine with hydrocortisone sodium succinate

Mesalazine

ACTIVE COMPARATOR

Mesalazine （4g）enema

Drug: Mesalazine

Hydrocortisone sodium succinate

ACTIVE COMPARATOR

Hydrocortisone sodium succinate (100mg ) enema

Drug: hydrocortisone sodium succinate

Interventions

Mesalazine DRUG

Mesalazine enema rectal administration at bedtime 4g/100 ml, once daily

Mesalazine

hydrocortisone sodium succinate DRUG

hydrocortisone sodium succinate rectal administration at bedtime 100mg/100 ml, once daily

Hydrocortisone sodium succinate

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

Mesalazine with hydrocortisone sodium succinate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead
• Shanghai Tongji Hospital, Tongji University School of Medicine: collaborator
• First Affiliated Hospital of Zhongshan Medical University: collaborator

Study Sites (1)

Xijing Digestive Disease

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine; Hydrocortisone

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• jie Liang, professor

  China,Shaanxi,Xi'an, Xijing Hospital of Digeetive Disease

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jie Liang, professor

CONTACT

86-029-85771535; liangjie@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: February 19, 2017
• First Posted: April 12, 2017
• Study Start: May 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 12, 2017

Record last verified: 2017-04

Locations

CN (1)