Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT03547232
Status:
RECRUITING
Last Update Posted:
2025-06-15
First Post:
2018-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D009102', 'term': 'Multiple Organ Failure'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1504}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2018-05-24', 'studyFirstSubmitQcDate': '2018-05-24', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hospitalization cost', 'timeFrame': '1 month', 'description': 'Expense of acute pancreatitis'}], 'primaryOutcomes': [{'measure': 'Occurence rate of organ dysfunction caused by acute pancreatitis', 'timeFrame': '1 week', 'description': 'Accumulation of varied organ dysfunction, especially the cardiovascular, renal and respiratory systems'}], 'secondaryOutcomes': [{'measure': 'Occurence rate of pancreatic necrosis', 'timeFrame': '1 month', 'description': 'Accumulation of the key local complication of acute pancreatitis'}, {'measure': 'Incidence rate of ICU admission', 'timeFrame': '1 month', 'description': 'Evaluation of critical severe acute pancreatitis'}, {'measure': 'Mortality', 'timeFrame': '1 month', 'description': 'The number of deaths during a particular period of time'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute pancreatitis', 'Indomethacin', 'Prognosis', 'Organ dysfunction'], 'conditions': ['Acute Pancreatitis', 'Complication', 'Mortality Rate', 'Organ Failure, Multiple']}, 'referencesModule': {'references': [{'pmid': '25872171', 'type': 'BACKGROUND', 'citation': 'Gorsky VA, Agapov MA, Khoreva MV, Leonenko IV. The effect of lornoxicam on TLR2 and TLR4 messenger RNA expression and tumor necrosis factor-alpha, interleukin-6, and interleukin-8 secretion in patients with systemic complications of acute pancreatitis. Pancreas. 2015 Jul;44(5):824-30. doi: 10.1097/MPA.0000000000000344.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/?term=25872171', 'label': 'A small sample study of NSAIDs for treatment of acute pancreatitis'}]}, 'descriptionModule': {'briefSummary': 'Acute pancreatitis (AP) is an inflammatory condition of the pancreas following the activated pancreatic enzymes induced by varied causes, with or without other organ(s) dysfunction. The production and release of inflammatory factors is generally considered as the key factor of pathogenesis. Non-steroidal anti-inflammatory drugs (NSAIDs) are the most commonly applied agents for inflammatory diseases. A series studies have proved that indomethacin can reduce the risk of post-endoscopic retrograde cholangiopancreatography (ERCP), but high-quality evidence is still lacking in the field of effectiveness of NSAIDs to treat, rather than prevent, other types of AP. Majority of animal experiments showed that NSAIDs had protective effects for organ functions, but the results of several preliminary clinical studies were inconsistent. Randomized controlled trials are eagerly awaited to elucidate its effects on AP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients ages 18-80 years with a diagnosis of AP based on at least 2 of the following criteria:\n* Abdominal pain characteristic of AP\n* Serum amylase and/or lipase ≥ 3 times the upper limit of normal\n* Characteristic findings of AP on abdominal CT scan will be screened for study enrollment.\n\nExclusion Criteria:\n\n* Onset time \\>24 hours\n* Presence of renal dysfunction (serum creatinine \\> 1.5 \\*normal upper limit)\n* Severe liver dysfunction\n* Active peptic ulcer disease or GI bleeding\n* Pregnancy or breast-feeding\n* Hypersensitivity to NSAIDs\n* New-onset, exacerbation or uncontrolled hypertension\n* Presence of serious cardiovascular events, including severe heart failure, myocardial infarction (MI) and stroke\n* Mental disability\n* Malignancy-associated acute pancreatitis\n* Post-ERCP pancreatitis\n* Informed consent not signed'}, 'identificationModule': {'nctId': 'NCT03547232', 'acronym': 'INDOMAP', 'briefTitle': 'Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial): Study Protocol for a Multi-center, Double-blinded, Placebo-controlled, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'I-23PJ1671'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indomethacin group', 'description': 'Indomethacin SR 50mg q12h from day1 to day 7 plus standard treatment for acute pancreatitis including adequate intravenous fluids, analgesics and early enteral nutrition support if possible.', 'interventionNames': ['Drug: Indomethacin SR']}, {'type': 'SHAM_COMPARATOR', 'label': 'Standard group', 'description': 'Similar shape and size suppositories without indomethacin (Placebos) given q12h from admission day 1 to day 7, plus standard treatment for acute pancreatitis including adequate intravenous fluids, analgesics and early enteral nutrition support if possible.', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Indomethacin SR', 'type': 'DRUG', 'otherNames': ['YINDUOMEIXIN'], 'description': 'Indomethacin SR 50mg given q12h from admission day 1 to day 7', 'armGroupLabels': ['Indomethacin group']}, {'name': 'Placebos', 'type': 'DRUG', 'otherNames': ['SHAM'], 'description': 'Similar shape and size suppositories (Placebos) without indomethacin given q12h from admission day 1 to day 7', 'armGroupLabels': ['Standard group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zuoyan Wu, MD', 'role': 'CONTACT'}], 'facility': 'Peking University Sixth Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dong Wu, M.D.', 'role': 'CONTACT'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '102401', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanfeng Wang, M.D.', 'role': 'CONTACT'}], 'facility': 'Liangxiang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '550005', 'city': 'Guiyang', 'state': 'Guizhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shanshan Yu, M.D.', 'role': 'CONTACT'}], 'facility': "Guiyang Second People's Hospital", 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'zip': '071000', 'city': 'Baoding', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhitao Lu, M.D.', 'role': 'CONTACT'}], 'facility': 'Baoding Seventh Hospital', 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'zip': '150001', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ruifeng Wang, MD', 'role': 'CONTACT'}], 'facility': 'Fourth Affiliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '411381', 'city': 'Dengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Na Wu, M.D.', 'role': 'CONTACT'}], 'facility': "Dengzhou People's Hospital", 'geoPoint': {'lat': 32.68222, 'lon': 112.08194}}, {'zip': '473012', 'city': 'Nanyang', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao Fan, M.D.', 'role': 'CONTACT'}], 'facility': 'Second People Hospital of Nanyang', 'geoPoint': {'lat': 32.99472, 'lon': 112.53278}}, {'zip': '223300', 'city': 'Huaian', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Shi, MD', 'role': 'CONTACT'}], 'facility': "The Second People's Hospital of Huai'an"}, {'zip': '226001', 'city': 'Nantong', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Baofeng Zhu, MD', 'role': 'CONTACT'}], 'facility': "Nantong First People's Hospital", 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'zip': '223800', 'city': 'Suqian', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming Sun, MD', 'role': 'CONTACT'}], 'facility': "Suqian People's Hospital", 'geoPoint': {'lat': 33.94917, 'lon': 118.29583}}, {'zip': '214043', 'city': 'Wuxi', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Huang, MD', 'role': 'CONTACT'}], 'facility': "Wuxi Third People's Hospital", 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'zip': '810001', 'city': 'Xining', 'state': 'Qinghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mei Liu, M.D.', 'role': 'CONTACT'}], 'facility': 'Qinghai University Affiliated Hospital', 'geoPoint': {'lat': 36.62554, 'lon': 101.75739}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shicheng Zheng, MD', 'role': 'CONTACT'}], 'facility': 'West China Longquan Hospital Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '830054', 'city': 'Ürümqi', 'state': 'Xinjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianzhong Yang, MD', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'zip': '321000', 'city': 'Jinhua', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Daoyuan Jing, MD', 'role': 'CONTACT'}], 'facility': 'Jinhua Municipal Central Hospital', 'geoPoint': {'lat': 29.10678, 'lon': 119.64421}}, {'zip': '323000', 'city': 'Lishui', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Liu, MD', 'role': 'CONTACT'}], 'facility': 'Lishui Municipal Central Hospital', 'geoPoint': {'lat': 28.46042, 'lon': 119.91029}}], 'centralContacts': [{'name': 'Dong Wu, M.D.', 'role': 'CONTACT', 'email': 'dongwu@pumc.edu.cn', 'phone': '8618612671010'}], 'overallOfficials': [{'name': 'Dong Wu, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking Union Medical College Hospital'}, {'name': 'Zhitao Lu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baoding Seventh Hospital'}, {'name': 'Yanfeng Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liangxiang Hospital'}, {'name': 'Shanshan Yu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guiyang Second People's Hospital"}, {'name': 'Na Wu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Dengzhou People's Hospital"}, {'name': 'Mei Liu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Hospital of Qinghai University'}, {'name': 'Xiao Fan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second People Hospital of Nanyang'}, {'name': 'Zuoyan Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Sixth Hospital'}, {'name': 'Ruifeng Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harbin Medical University'}, {'name': 'Baofeng Zhu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nantong First People's Hospital"}, {'name': 'Yan Shi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Second People's Hospital of Huai'an"}, {'name': 'Ming Sun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Suqian People's Hospital"}, {'name': 'Wei Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Wuxi Third People's Hospital"}, {'name': 'Shicheng Zheng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Longquan Hospital Sichuan University'}, {'name': 'Jianzhong Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Xinjiang Medical University'}, {'name': 'Daoyuan Jing, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jinhua Municipal Central Hospital'}, {'name': 'Hong Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lishui Municipal Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Gastroenterology', 'investigatorFullName': 'DONG WU', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}