The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer
NCT ID: NCT02769494
Last Updated: 2023-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2016-03-31
2017-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with oral ulcer and confirmed Crohn's disease.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Xijing Hospital of Digestive Diseases
OTHER
Responsible Party
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Yongquan Shi
Doctor of Xijing Hospital of Digestive Diseases,Principal
Principal Investigators
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Ying Han, Ph. D
Role: STUDY_DIRECTOR
Degistive Disease of Xijing Hospital, Fourth Military Medical University
Locations
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Xijing Hospital
Xi'an, Shaanxi, China
Countries
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Other Identifiers
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KY20160107-1
Identifier Type: -
Identifier Source: org_study_id
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