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

Xijing Hospital of Digestive Diseases

Status and phase: Withdrawn; Phase 3

Conditions: Oral Ulcer; Crohn's Disease

Treatments: Drug: Mesalazine Sustained-Release Tablets; Drug: Riboflavin Sodium Phosphate Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02769494

KY20160107-1

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18~65, both gender.
• Patients with oral ulcer and confirmed Crohn's disease.

Exclusion criteria

• Contraindications to study drugs.
• Underwent or will accept oral Surgery.
• Patients are not able to sign the informed consent or not comply with the study protocol.
• Planning for pregnancy, pregnancy and lactating women.
• Enrolled in other clinical trials in the past 30 days.
• Patients with concurrent / new other serious diseases will affect the effectiveness and safety evaluation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Mesalazine Group

Experimental group

Description:

Mesalazine Sustained-Release Tablets and 0.02L glycerol mixed, 2.5% mesalazine glycerol suspension liquid, gently apply to the ulcer surface, 3 times/day. Daily treatment time of the drug is 8 am,12 pm and 4 pm.

Treatment:

Drug: Mesalazine Sustained-Release Tablets

Riboflavin Sodium Phosphate Group

Active Comparator group

Description:

wipe the riboflavin sodium phosphate injection to the ulcer surface, 3 times/day. Daily treatment time of the drug is am,12 pm and 4 pm.

Treatment:

Drug: Riboflavin Sodium Phosphate Injection