Crohn's Disease, Oral Ulcer
Conditions
Keywords
Oral ulcer, Crohn's disease
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.
Interventions
DRUGMesalazine 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.
DRUGRiboflavin 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.
Sponsors
Xijing Hospital of Digestive Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18\ 65, both gender. * Patients with oral ulcer and confirmed Crohn's disease.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed