The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mesalazine Group 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
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.
Other Names:
|
| Active Comparator: Riboflavin Sodium Phosphate Group 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
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.
|
Outcome Measures
Primary Outcome Measures
- oral ulcer healing [the 7 Days of treatment.]
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.
- oral ulcer recurrence [the 28 Days after the end of treatment.]
to observe the recurrence rate of ulcer
Secondary Outcome Measures
- symptoms effective rates [At the 7 Days of the treatment, and the 28 Days after the end of treatment.]
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.
- adverse events [From 1st Day to 7th Days of the treatment and the 28 Days after the end of treatment.]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age between 18~65, both gender.
-
Patients with oral ulcer and confirmed Crohn's disease.
Exclusion Criteria:
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Contraindications to study drugs.
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Underwent or will accept oral Surgery.
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Patients are not able to sign the informed consent or not comply with the study protocol.
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Planning for pregnancy, pregnancy and lactating women.
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Enrolled in other clinical trials in the past 30 days.
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Patients with concurrent / new other serious diseases will affect the effectiveness and safety evaluation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xijing Hospital | Xi'an | Shaanxi | China | 710032 |
Sponsors and Collaborators
- Xijing Hospital of Digestive Diseases
Investigators
- Study Director: Ying Han, Ph. D, Degistive Disease of Xijing Hospital, Fourth Military Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY20160107-1