Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-09 @ 10:09 PM
Study NCT ID:
NCT01586533
Status:
UNKNOWN
Last Update Posted:
2014-01-08
First Post:
2012-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'lastUpdateSubmitDate': '2014-01-07', 'studyFirstSubmitDate': '2012-04-25', 'studyFirstSubmitQcDate': '2012-04-26', 'lastUpdatePostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in modified UCDAI at 6 weeks', 'timeFrame': '6 weeks', 'description': 'Change from baseline in the modified Ulcerative Colitis Disease Activity Index (modified UCDAI) score at the end of the 6 week treatment period of Zoenasa™ Rectal Gel compared with mesalamine'}], 'secondaryOutcomes': [{'measure': 'Change in modified UCDAI at 3 weeks', 'timeFrame': '3 weeks', 'description': 'Change from baseline in the modified Ulcerative Colitis Disease Activity Index (modified UCDAI) score at the end of the 3 week treatment period of Zoenasa™ Rectal Gel compared with mesalamine'}, {'measure': 'Clinical and endoscopic remission rates at 6 weeks', 'timeFrame': '6 weeks', 'description': 'Proportion of patients in clinical and endoscopic remission at 6 weeks compared to baseline'}, {'measure': 'Clinical and endoscopic remission rates at 3 weeks', 'timeFrame': '3 weeks', 'description': 'Proportion of patients in clinical and endoscopic remission at 3 weeks compared to baseline'}, {'measure': 'Clinical improvement rate after 6 weeks', 'timeFrame': '6 weeks'}, {'measure': 'Clinical improvement rate after 3 weeks', 'timeFrame': '3 weeks'}, {'measure': 'Endoscopic improvement rate at 6 weeks', 'timeFrame': '6 weeks'}, {'measure': 'Endoscopic improvement rate at 3 weeks', 'timeFrame': '3 weeks'}, {'measure': 'Change from baseline in endoscopic appearance after 6 weeks', 'timeFrame': '6 weeks'}, {'measure': 'Change from baseline in endoscopic appearance after 3 weeks', 'timeFrame': '3 weeks'}, {'measure': 'Time to resolution of rectal bleeding', 'timeFrame': 'Up to 6 weeks'}, {'measure': 'Relapse rates at 6 weeks', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ulcerative colitis', 'UC', 'left-sided ulcerative colitis', 'distal ulcerative colitis', 'Zoenasa', 'mesalamine', 'mesalazine', '5-ASA', '5-aminosalicylic acid', 'N-acetylcysteine', 'acetylcysteine', 'NAC', 'enema', 'rectal gel'], 'conditions': ['Ulcerative Colitis', 'Left-sided Ulcerative Colitis', 'Distal Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'This double-blind, randomized, comparator-controlled Phase II study is designed to establish the safety and efficacy of Zoenasa Rectal Gel compared to mesalamine enema in subjects with left-sided ulcerative colitis, as measured by the modified ulcerative colitis disease activity index (UCDAI), over 6 weeks of treatment. In this study, two cohorts of subjects will receive either Zoenasa-1:4 (1.0g NAC; 4.0g 5-ASA) investigational drug enema therapy or comparator mesalamine enema (4.0g 5-ASA). The study will enroll subjects randomized equally into the 2 cohorts. Each cohort will enroll approximately 60 subjects. The two arms of the trial will be enrolled concurrently in a randomized fashion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female subjects are eligible if they are ≥ 18 years of age and ≤ 64 years.\n* They have a documented history of idiopathic ulcerative colitis based on endoscopic and/or histologic findings involving the left side of the colon, with mild to moderate active disease.\n* Eligible subjects will have a documented history of ulcerative colitis, and a modified UCDAI score of 4-10, inclusive, with a Physician's rating of disease score of 2 points or less (mild or moderate active ulcerative colitis), rectal bleeding score of 1 or more (based on subject diary), and mucosal appearance score (based on endoscopy) of 1 point or more at baseline.\n* Laboratory data:\n\n * White blood cell count between 4.0 - 12.0 K/mm3\n * Platelet count: 150 - 500 K/mm3\n * Hemoglobin \\> 10.0 g/dL\n * Total bilirubin \\< 1.5 mg/dL\n * Aspartate aminotransferase \\< 100 u/dL\n * Alanine aminotransferase \\< 100 u/dL\n * Alkaline phosphatase \\< 250 u/dL\n * Blood urine nitrogen \\< 40 mg/dL\n * Creatinine \\< 1.5 mg/dL\n* Satisfies one of the following:\n* Female subjects of childbearing potential must have a negative urine pregnancy test at screening; surgically sterile, post-menopausal, abstinent, or patient or partner agree to use a medically appropriate form of birth control from screening to until 1 month after the last dose of study medication.\n* Male subjects must be surgically sterile, abstinent, or patient or partner compliant with a contraceptive regimen from screening to until 1 month after the last dose of study medication.\n* They are able to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.\n\nExclusion Criteria:\n\n* They have documented history of proximal or universal ulcerative colitis, proctitis or active proctitis confined to 15cm or less from the anal verge.\n* They demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis.\n* They receive a Physician's rating of disease severity as part of the modified UCDAI of 3 (severe disease) or an aggregate score of 11 or greater.\n* They have shown prior documented history of evidence of high grade dysplasia on biopsy from endoscopic examinations.\n* Their stool contains enteric pathogens or Clostridium difficile toxins.\n* They have a history of recurrent Clostridium difficile infection.\n* They have prior history of biologic therapy within the previous 4 years.\n* They have received systemic steroids or immunosuppressants within the previous 4 weeks.\n* Treatment in the last 14 days that included antibiotic, antifungal, antiparasitic medications, or rectally administered steroids (e.g. Cortenema®) or mesalamine enema (Rowasa®).\n* Treatment in the last 7 days that included mesalamine (5-ASA) via oral administration (e.g. Asacol®, Lialda®, balsalazide, etc).\n* They have a history of cancer (defined as malignancy within 5 years except for squamous cell or basal cell cancers of the skin), asthma, or bronchospasm.\n* Positive pregnancy test or lactating subjects.\n* There is evidence of chemical substance abuse.\n* They have had repeated anti-inflammatory drug treatment (longer than 3 days at doses that exceed those available without a prescription) within the previous 7 days (with exception of aspirin at doses of 325mg/day or less for prophylaxis of cardiac disease), or initiated new non-steroidal anti-inflammatory (NSAID) treatment within the last 30 days.\n* They have a known allergy to N-acetylcysteine or mesalamine, or have a history of serious AEs related to their use (including, but not limited to pancreatitis or hepatitis).\n* They have a history of failure to retain enemas.\n* Other clinically significant diseases that could interfere with the protocol compliance appear. These would include clinically important hematological, renal, hepatic, metabolic, psychiatric, central nervous system (CNS), pulmonary or cardiovascular disease.\n* Use of any investigational medication within the previous 90 days.\n* Any condition which the study physician judges to preclude safe participation in the study or to confound the evaluation of the study outcome."}, 'identificationModule': {'nctId': 'NCT01586533', 'briefTitle': 'Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Altheus Therapeutics, Inc.'}, 'officialTitle': 'A Phase II Double-blind, Randomized, Comparator-controlled Study of the Safety and Efficacy of Zoenasa™ Rectal Gel (Mesalamine Plus N-acetylcysteine) in Subjects With Left-sided Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'ZA-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zoenasa-1:4', 'interventionNames': ['Drug: Zoenasa-1:4']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mesalamine Enema', 'interventionNames': ['Drug: Mesalamine Enema']}], 'interventions': [{'name': 'Zoenasa-1:4', 'type': 'DRUG', 'description': 'Zoenasa Rectal Gel (4.0g mesalamine \\[5-ASA\\], 1.0g N-acetylcysteine \\[NAC\\]; 60ml)', 'armGroupLabels': ['Zoenasa-1:4']}, {'name': 'Mesalamine Enema', 'type': 'DRUG', 'description': 'Mesalamine Rectal Suspension Enema (4.0g mesalamine \\[5-ASA\\], 60ml)', 'armGroupLabels': ['Mesalamine Enema']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham Gastroenterology Associates', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Digestive Health Specialists of the Southeast', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '80214', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Gastroenterology', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '32605', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Digestive Disease Associates', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Digestive Medical Associates', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'The Center for Gastrointestinal Disorders', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33156', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Gastroenterology Consultants P.A.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33186', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'South Medical Research Group', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Gastroenterology of Naples', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '34684', 'city': 'Palm Harbor', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Gastroenterology Associates', 'geoPoint': {'lat': 28.07807, 'lon': -82.76371}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Shafran Gastroenterology', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '30606', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Tri-County Research', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Digestive Healthcare of Georgia', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Atlanta Center for Gastroenterology', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '31405', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'St. Josephs Candler Health System', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60004', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'NCH Medical Group', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '52807', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Gastrointestinal Clinic of Quad Cities', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '67203', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Professional Research Network of Kansas', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Clinical Trials 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-73.72846}}, {'zip': '10028', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Associates of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Asheville Gastroenterology Associates, P.A.', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '28036', 'city': 'Davidson', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Digestive Health Associates', 'geoPoint': {'lat': 35.50233, 'lon': -80.83912}}, {'zip': '27403', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'LeBauer Research Associates, P.A.', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Greater Cincinnati Gastroenterology', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '73071', 'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Central Sooner Research', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Foundation for Digestive Research', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Options Health Research', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '74135', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Gastroenterology United Tulsa', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Gastro One', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Memphis Gastroenterology Group', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas VA Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Digestive Disease Clinic', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75075', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Digestive Health Associates of Texas', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '84405', 'city': 'South Ogden', 'state': 'Utah', 'country': 'United States', 'facility': 'Advanced Research Institute', 'geoPoint': {'lat': 41.19189, 'lon': -111.97133}}, {'zip': '24073', 'city': 'Christiansburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'New River Valley Research Institute', 'geoPoint': {'lat': 37.12985, 'lon': -80.40894}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Digestive & Liver Disease Specialists', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Digestive Disease Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Franciscan Research Center', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Wisconsin Center for Advanced Research', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Altheus Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}