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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Efficacy of Topically Applied Mesalazine Sustained-Release Tablets in Oral Lesions of 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 Summary:

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.

Current Primary Outcome:

• oral ulcer healing [ Time Frame: 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 [ Time Frame: the 28 Days after the end of treatment. ]
  to observe the recurrence rate of ulcer

Original Primary Outcome: Same as current

Current Secondary Outcome:

• symptoms effective rates [ Time Frame: 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 [ Time Frame: 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.

Original Secondary Outcome: Same as current

Information By: Xijing Hospital of Digestive Diseases

Dates:
Date Received: March 9, 2016
Date Started: March 2016
Date Completion: January 2017
Last Updated: May 10, 2016
Last Verified: January 2016