The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer
- Conditions
- Crohn's DiseaseOral Ulcer
- Interventions
- Registration Number
- NCT02769494
- Lead Sponsor
- Xijing Hospital of Digestive Diseases
- 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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Age between 18~65, both gender.
- Patients with oral ulcer and confirmed Crohn's disease.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mesalazine Group Mesalazine Sustained-Release Tablets 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. Riboflavin Sodium Phosphate Group Riboflavin Sodium Phosphate Injection 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Xijing Hospital
🇨🇳Xi'an, Shaanxi, China