NCT02769494

The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer

The Efficacy of Topically Applied Mesalazine Sustained-Release Tablets in Oral Lesions of Crohn's Disease

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims at evaluating efficacy and safety of topical using Mesalazine Sustained-Release Tablets in in the treatment of oral ulcers in patients with Crohn's disease.

Detailed description

The study will include three phases: screening, treatment and follow-up. Screening: This phase will last a maximum of 7 days and subjects eligibility will be evaluated after informed consent signature. Treatment: Subjects are randomly assigned to treatment and will be treated for 7 days. Daily oral ulcer area and symptoms were recorded during the treatment period. A randomization visit will take place on day 0 and an end-of-treatment visit will take place between day 6 and 8. Follow-up: 28 days after the end of treatment. Efficacy of treatment was evaluated by the oral ulcer remission or decreasing.

Conditions

• Crohn's Disease
• Oral Ulcer

Interventions

Type	Name	Description
DRUG	Mesalazine Sustained-Release Tablets	Mesalazine sustained-release tablets 500mg and 0.02L glycerol mixed, the preparation of 2.5% the mesalazine glycerol suspension liquid, gently apply to the ulcer surface, 3 times/day. The application time of the drug is 8:00,12:00, 16:00. Daily 20:00 measure the size of the mouth ulcers and record the symptoms in the diary card.
DRUG	Riboflavin Sodium Phosphate Injection	gently apply the riboflavin sodium phosphate injection to the ulcer surface, 3 times/day. The application time of the drug is 8:00,12:00, 16:00. Daily 20:00 measure the size of the mouth ulcers and record the symptoms in the diary card.

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-12-01
• Completion: 2017-01-01
• First posted: 2016-05-11
• Last updated: 2023-02-01

Locations

1 site across 1 country: China