The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer

Crohn's Disease Clinical Trial

Official title:

The Efficacy of Topically Applied Mesalazine Sustained-Release Tablets in Oral Lesions of Crohn's Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02769494
• Other study ID #: KY20160107-1
• Status: Withdrawn
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: January 2017

Study information

• Verified date: January 2023
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Oral Ulcer
• Ulcer

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	the 7 Days of treatment.
Primary	oral ulcer recurrence	to observe the recurrence rate of ulcer	the 28 Days after the end of treatment.
Secondary	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.	At the 7 Days of the treatment, and the 28 Days after the end of treatment.
Secondary	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.	From 1st Day to 7th Days of the treatment and the 28 Days after the end of treatment.