The Efficacy of Topically Applied Mesalazine Sustained-Release Tablets in Oral Lesions of Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- oral ulcer healing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18~65, both gender.
- •Patients with oral ulcer and confirmed Crohn's disease.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Mesalazine Sustained-Release Tablets (Drug)
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.
干预措施: Riboflavin Sodium Phosphate Injection (Drug)
结局指标
主要结局
oral ulcer healing
时间窗: 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
时间窗: the 28 Days after the end of treatment.
to observe the recurrence rate of ulcer
次要结局
- symptoms effective rates(At the 7 Days of the treatment, and the 28 Days after the end of treatment.)
- adverse events(From 1st Day to 7th Days of the treatment and the 28 Days after the end of treatment.)
研究者
Yongquan Shi
Doctor of Xijing Hospital of Digestive Diseases,Principal
Xijing Hospital of Digestive Diseases