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

NCT03110198 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 528

Last updated 2017-04-12

No results posted yet for this study

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

Interventions

DRUG

Mesalazine

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

DRUG

hydrocortisone sodium succinate

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

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

Sponsors & Collaborators

  • Shanghai Tongji Hospital, Tongji University School of Medicine

    collaborator OTHER

  • First Affiliated Hospital of Zhongshan Medical University

    collaborator OTHER

  • Xijing Hospital of Digestive Diseases

    lead OTHER

Principal Investigators

  • jie Liang, professor · China,Shaanxi,Xi'an, Xijing Hospital of Digeetive Disease

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-31
Primary Completion
2018-01-31
Completion
2018-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03110198 on ClinicalTrials.gov