A Phase 3 interventional study of Mesalazine Sustained-Release Tablets and Riboflavin Sodium Phosphate Injection in Crohn's Disease and Oral Ulcer, sponsored by Xijing Hospital of Digestive Diseases. Withdrawn at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-01.
Sponsored by Xijing Hospital of Digestive Diseases · Phase 3, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
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
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
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.
Also known as: Pentasa
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.
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.
Time frame: the 7 Days of treatment.
oral ulcer recurrence
to observe the recurrence rate of ulcer
Time frame: the 28 Days after the end of treatment.
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.
Time frame: 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.
Time frame: From 1st Day to 7th Days of the treatment and the 28 Days after the end of treatment.
Plan to share: No
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This study is withdrawn, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Xijing Hospital of Digestive Diseases