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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Crohn's Disease, Oral Ulcer

Intervention / Treatment
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* Drug: Mesalazine Sustained-Release Tablets
* Drug: Riboflavin Sodium Phosphate Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesalazine Group<br>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. | Drug: Mesalazine Sustained-Release Tablets<br>* 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.<br>* Other names: Pentasa;|
| Active Comparator: Riboflavin Sodium Phosphate Group<br>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. | Drug: Riboflavin Sodium Phosphate Injection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral ulcer healing | The primary outcome is ulcer healing, oral ulcer area can be divided into 3 degrees: 1 degrees for a single ulcer, area ≤ 8mm; 2 degree for a single ulcer, 8mm ≤ area ≤ 15mm, or two ulcers, area of every ulcer ≤ 8mm; 3 degree for a single ulcer, area ≥ 15 mm, or 2 ulcers, every area between 8 to 15mm. Recovery refers oral ulcer is healing completely. The effective is the ulcer area decrease more than 1 degree. Invalid means the ulcer area is no change. | the 7 Days of treatment. | 
| oral ulcer recurrence | to observe the recurrence rate of ulcer | the 28 Days after the end of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms effective rates | Symptom effective rate =（total score before treatment - total score after treatment）/total score before treatment x 100%. Total score = frequency + severity. Frequency score is calculated by all the frequency of oral pain, anorexia,and eating difficult. Severity is accumulated by the degree of symptoms described above,which is divided to 4 degree as 0 presenting none,and 3 presenting most severe. | At the 7 Days of the treatment, and the 28 Days after the end of treatment. | 
| adverse events | Participants with Adverse Events as a Measure of Safety and Tolerability. The common side effects of the study include headache, diarrhea, nausea, abdominal pain, vomiting and skin rash. | From 1st Day to 7th Days of the treatment and the 28 Days after the end of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral ulcer, Crohn's disease