Back to resultsThe Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer
Primary Purpose
Crohn's Disease, Oral Ulcer
Status
Withdrawn
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Mesalazine Sustained-Release Tablets
Riboflavin Sodium Phosphate Injection
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Oral ulcer, Crohn's disease
Eligibility Criteria
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.
Sites / Locations
- Xijing Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mesalazine Group
Riboflavin Sodium Phosphate Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
oral ulcer recurrence
to observe the recurrence rate of ulcer
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02769494
First Posted
March 9, 2016
Last Updated
January 30, 2023
Sponsor
Xijing Hospital of Digestive Diseases
1. Study Identification
Unique Protocol Identification Number
NCT02769494
Brief Title
The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer
Official Title
The Efficacy of Topically Applied Mesalazine Sustained-Release Tablets in Oral Lesions of Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funds
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital of Digestive Diseases
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Oral Ulcer
Keywords
Oral ulcer, Crohn's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mesalazine Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Riboflavin Sodium Phosphate Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Mesalazine Sustained-Release Tablets
Other Intervention Name(s)
Pentasa
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Riboflavin Sodium Phosphate Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
oral ulcer healing
Description
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.
Time Frame
the 7 Days of treatment.
Title
oral ulcer recurrence
Description
to observe the recurrence rate of ulcer
Time Frame
the 28 Days after the end of treatment.
Secondary Outcome Measure Information:
Title
symptoms effective rates
Description
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.
Time Frame
At the 7 Days of the treatment, and the 28 Days after the end of treatment.
Title
adverse events
Description
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.
Time Frame
From 1st Day to 7th Days of the treatment and the 28 Days after the end of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Han, Ph. D
Organizational Affiliation
Degistive Disease of Xijing Hospital, Fourth Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer
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