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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 February 2023 |
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Main ID: |
NCT02769494 |
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Date of registration:
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09/03/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer
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Scientific title:
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The Efficacy of Topically Applied Mesalazine Sustained-Release Tablets in Oral Lesions of Crohn's Disease |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02769494 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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China
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Contacts
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Name:
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Ying Han, Ph. D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Degistive Disease of Xijing Hospital, Fourth Military Medical University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Oral Ulcer
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Crohn's Disease
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Intervention(s)
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Drug: Mesalazine Sustained-Release Tablets
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Drug: Riboflavin Sodium Phosphate Injection
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Primary Outcome(s)
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oral ulcer recurrence
[Time Frame: the 28 Days after the end of treatment.]
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oral ulcer healing
[Time Frame: the 7 Days of treatment.]
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Secondary Outcome(s)
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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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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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Secondary ID(s)
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KY20160107-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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