- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02769494
The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer
The Efficacy of Topically Applied Mesalazine Sustained-Release Tablets in Oral Lesions of Crohn's Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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Shaanxi
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Xi'an, Shaanxi, China, 710032
- Xijing Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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 Names:
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
oral ulcer healing
Time Frame: the 7 Days of treatment.
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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.
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the 7 Days of treatment.
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oral ulcer recurrence
Time Frame: the 28 Days after the end of treatment.
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to observe the recurrence rate of ulcer
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the 28 Days after the end of treatment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
symptoms effective rates
Time Frame: At the 7 Days of the treatment, and the 28 Days after the end of treatment.
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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.
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At the 7 Days of the treatment, and the 28 Days after the end of treatment.
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adverse events
Time Frame: From 1st Day to 7th Days of the treatment and the 28 Days after the end of treatment.
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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.
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From 1st Day to 7th Days of the treatment and the 28 Days after the end of treatment.
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Collaborators and Investigators
Investigators
- Study Director: Ying Han, Ph. D, Degistive Disease of Xijing Hospital, Fourth Military Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Gastroenteritis
- Stomatognathic Diseases
- Mouth Diseases
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Ulcer
- Crohn Disease
- Oral Ulcer
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Photosensitizing Agents
- Dermatologic Agents
- Micronutrients
- Vitamins
- Vitamin B Complex
- Riboflavin
- Mesalamine
- Flavin Mononucleotide
Other Study ID Numbers
- KY20160107-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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