Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-03-07 @ 6:48 AM
Study NCT ID:
NCT02769494
Status:
WITHDRAWN
Last Update Posted:
2023-02-01
First Post:
2016-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D019226', 'term': 'Oral Ulcer'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019804', 'term': 'Mesalamine'}, {'id': 'D005486', 'term': 'Flavin Mononucleotide'}], 'ancestors': [{'id': 'D062368', 'term': 'meta-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000636', 'term': 'Aminosalicylic Acids'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D012256', 'term': 'Riboflavin'}, {'id': 'D005415', 'term': 'Flavins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D012265', 'term': 'Ribonucleotides'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of funds', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2016-03-09', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oral ulcer healing', 'timeFrame': 'the 7 Days of treatment.', '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.'}, {'measure': 'oral ulcer recurrence', 'timeFrame': 'the 28 Days after the end of treatment.', 'description': 'to observe the recurrence rate of ulcer'}], 'secondaryOutcomes': [{'measure': 'symptoms effective rates', 'timeFrame': 'At the 7 Days of the treatment, and the 28 Days after the end of treatment.', '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.'}, {'measure': 'adverse events', 'timeFrame': 'From 1st Day to 7th Days of the treatment and the 28 Days after the end of treatment.', '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Oral ulcer', "Crohn's disease"], 'conditions': ["Crohn's Disease", 'Oral Ulcer']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': 'The study will include three phases: screening, treatment and follow-up.\n\nScreening: This phase will last a maximum of 7 days and subjects eligibility will be evaluated after informed consent signature.\n\nTreatment: 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.\n\nFollow-up: 28 days after the end of treatment. Efficacy of treatment was evaluated by the oral ulcer remission or decreasing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18\\~65, both gender.\n* Patients with oral ulcer and confirmed Crohn's disease.\n\nExclusion Criteria:\n\n* Contraindications to study drugs.\n* Underwent or will accept oral Surgery.\n* Patients are not able to sign the informed consent or not comply with the study protocol.\n* Planning for pregnancy, pregnancy and lactating women.\n* Enrolled in other clinical trials in the past 30 days.\n* Patients with concurrent / new other serious diseases will affect the effectiveness and safety evaluation."}, 'identificationModule': {'nctId': 'NCT02769494', 'briefTitle': "The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer", 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital of Digestive Diseases'}, 'officialTitle': "The Efficacy of Topically Applied Mesalazine Sustained-Release Tablets in Oral Lesions of Crohn's Disease", 'orgStudyIdInfo': {'id': 'KY20160107-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mesalazine Group', '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.', 'interventionNames': ['Drug: Mesalazine Sustained-Release Tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Riboflavin Sodium Phosphate Group', '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.', 'interventionNames': ['Drug: Riboflavin Sodium Phosphate Injection']}], 'interventions': [{'name': 'Mesalazine Sustained-Release Tablets', 'type': 'DRUG', 'otherNames': ['Pentasa'], '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.', 'armGroupLabels': ['Mesalazine Group']}, {'name': 'Riboflavin Sodium Phosphate Injection', 'type': 'DRUG', '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.', 'armGroupLabels': ['Riboflavin Sodium Phosphate Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Ying Han, Ph. D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Degistive Disease of Xijing Hospital, Fourth Military Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital of Digestive Diseases', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor of Xijing Hospital of Digestive Diseases,Principal', 'investigatorFullName': 'Yongquan Shi', 'investigatorAffiliation': 'Xijing Hospital of Digestive Diseases'}}}}