Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-03-02 @ 4:22 PM
Study NCT ID:
NCT05316220
Status:
WITHDRAWN
Last Update Posted:
2025-08-12
First Post:
2022-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019804', 'term': 'Mesalamine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'strategic considerations', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2022-03-31', 'studyFirstSubmitQcDate': '2022-03-31', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Maintaining Clinical Remission Responder Status Based on the modified Mayo Score (mMS)', 'timeFrame': 'Week 26', 'description': 'Clinical remission responder based on the mMS is defined as Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore \\<= 1.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Maintaining Endoscopic Remission Responder Status Based on the mMS', 'timeFrame': 'Week 26', 'description': 'Endoscopic remission responder based on the mMS is defined as Endoscopy subscore = 0 or 1.'}, {'measure': 'Percentage of Participants Maintaining Symptomatic Remission Responder Status Based on the mMS', 'timeFrame': 'Week 26', 'description': 'Symptomatic remission responder based on the mMS s defined as Rectal bleeding subscore = 0 AND Stool frequency subscore \\<= 1.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ulcerative Colitis (UC)', 'Mesalamine', 'Delzicol', 'AGN-226474'], 'conditions': ['Ulcerative Colitis (UC)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) characterized by diffuse, continuous inflammation of the colon. This study will assess how safe and effective mesalamine delayed-release capsules are in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed.\n\nDelzicol (Mesalamine) is an approved drug being developed for the treatment of Ulcerative Colitis (UC). Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. Around 80 Pediatric participants aged 5 to 17 years with a diagnosis of UC will be enrolled in approximately 45 sites in the United States.\n\nParticipants will receive oral mesalamine capsules twice daily for 26 weeks and followed for 30 days.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Documented history of Ulcerative Colitis (UC) who have been successfully maintained in remission for at least 30 days prior to the screening visit and are on a stable dose of mesalamine or 5-aminosalicylic acid equivalent.\n\nExclusion Criteria:\n\n\\- Abnormal and clinically significant results according to the investigator or designee, on physical examination, medical history, electrocardiogram (ECG), hematology, clinical chemistry, or urinalysis.'}, 'identificationModule': {'nctId': 'NCT05316220', 'briefTitle': 'A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Randomized, Double-blind Study to Assess the Safety and Efficacy of Mesalamine Delayed-release Capsules in Children Aged 5 to 17 Years for the Maintenance of Remission of Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'M21-517'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mesalamine Dose A', 'description': 'Participants will receive mesalamine Dose A twice daily for 26 weeks.', 'interventionNames': ['Drug: Mesalamine']}, {'type': 'EXPERIMENTAL', 'label': 'Mesalamine Dose B', 'description': 'Participants will receive mesalamine Dose B twice daily for 26 weeks.', 'interventionNames': ['Drug: Mesalamine', 'Drug: Placebo']}], 'interventions': [{'name': 'Mesalamine', 'type': 'DRUG', 'otherNames': ['Delzicol'], 'description': 'Oral Capsules', 'armGroupLabels': ['Mesalamine Dose A', 'Mesalamine Dose B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral Capsule', 'armGroupLabels': ['Mesalamine Dose B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010-2916', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Childrens National /ID# 243379', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32225-3131', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Angel Kids Pediatrics /ID# 244874', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30315', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Treken Primary Care /ID# 241302', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60621', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Eagle Clinical Research /ID# 242045', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '20910', 'city': 'Silver Spring', 'state': 'Maryland', 'country': 'United States', 'facility': 'Virgo Carter Pediatrics /ID# 241556', 'geoPoint': {'lat': 38.99067, 'lon': -77.02609}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH Cleveland Medical Center /ID# 243375', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': "Children's Hospital Oklahoma /ID# 242614", 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '24014', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Carilion Medical Center /ID# 244398', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': '726', 'city': 'Caguas', 'country': 'Puerto Rico', 'facility': 'San Juan Bautista School of Medicine /ID# 243377', 'geoPoint': {'lat': 18.23412, 'lon': -66.0485}}, {'zip': '912', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': "Centro de Investigaciones Clinicas San Jorge Children's and Women's Hospital /ID# 244595", 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'For details on when studies are available for sharing, please refer to the link below.', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}