NCT03110198

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

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)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 528 (estimated)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-01-01
• Completion: 2018-03-01
• First posted: 2017-04-12
• Last updated: 2017-04-12

Locations

1 site across 1 country: China