The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer
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|ClinicalTrials.gov Identifier: NCT02769494|
Recruitment Status : Unknown
Verified January 2016 by Yongquan Shi, Xijing Hospital of Digestive Diseases.
Recruitment status was: Recruiting
First Posted : May 11, 2016
Last Update Posted : May 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease Oral Ulcer||Drug: Mesalazine Sustained-Release Tablets Drug: Riboflavin Sodium Phosphate Injection||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy of Topically Applied Mesalazine Sustained-Release Tablets in Oral Lesions of Crohn's Disease|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||January 2017|
Experimental: 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.
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.
Other Name: Pentasa
Active Comparator: 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.
Drug: 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.
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769494
|Contact: Ying Hanfirstname.lastname@example.org|
|Xi'an, Shaanxi, China, 710032|
|Contact: Yongquan Shi, Ph. D +86-29-84771515 email@example.com|
|Study Director:||Ying Han, Ph. D||Degistive Disease of Xijing Hospital, Fourth Military Medical University|