{"id":"lubiprostone-24","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Nausea"},{"rate":"15-25","effect":"Diarrhea"},{"rate":"10-20","effect":"Abdominal pain"},{"rate":"5-15","effect":"Headache"},{"rate":"5-10","effect":"Vomiting"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Lubiprostone activates ClC-2 chloride channels on the apical membrane of gastrointestinal epithelial cells, increasing chloride and fluid secretion into the intestinal lumen. This increased fluid content enhances stool consistency and promotes normal bowel function, providing relief from chronic idiopathic constipation and other constipation-related conditions.","oneSentence":"Lubiprostone is a ClC-2 chloride channel activator that increases intestinal fluid secretion and promotes bowel motility to relieve constipation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:19:44.170Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic idiopathic constipation"},{"name":"Irritable bowel syndrome with constipation (IBS-C)"},{"name":"Opioid-induced constipation"}]},"trialDetails":[{"nctId":"NCT07405736","phase":"PHASE2","title":"Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal Cancer","status":"NOT_YET_RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2026-02-24","conditions":"Colorectal Cancer Metastatic, Peritoneal (Metastatic) Cancer, Peritoneal Metastasis","enrollment":124},{"nctId":"NCT07277907","phase":"PHASE3","title":"Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation","status":"RECRUITING","sponsor":"Third Military Medical University","startDate":"2025-11-13","conditions":"Slow Transit Constipation, Pharmacotherapy","enrollment":346},{"nctId":"NCT04361656","phase":"","title":"The Effect of Adding Lubiprostone to Standard Large-Volume PEG-ELS on The Quality of Inpatient Colonoscopy Preparation","status":"WITHDRAWN","sponsor":"Henry Ford Health System","startDate":"2020-05-01","conditions":"Colonoscopy Preparation","enrollment":""},{"nctId":"NCT05768334","phase":"PHASE3","title":"Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease","status":"COMPLETED","sponsor":"Helwan University","startDate":"2020-11-01","conditions":"NAFLD","enrollment":116},{"nctId":"NCT01839734","phase":"PHASE2","title":"Lubiprostone as a Modulator of Gut Microbial Translocation in HIV With Incomplete CD4 Recovery on Antiretroviral Therapy","status":"COMPLETED","sponsor":"Ruth M. Rothstein CORE Center","startDate":"2013-06","conditions":"HIV","enrollment":20},{"nctId":"NCT00645801","phase":"PHASE4","title":"Amitiza® Plus GoLYTELY® (PEG) Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation","status":"COMPLETED","sponsor":"Henry Ford Health System","startDate":"2008-03","conditions":"Colonoscopy","enrollment":158},{"nctId":"NCT00908076","phase":"PHASE4","title":"Amitiza in Constipation Associated With PD (Parkinson's Disease)","status":"COMPLETED","sponsor":"Baylor College of Medicine","startDate":"2009-02","conditions":"Parkinson's Disease","enrollment":78},{"nctId":"NCT05144295","phase":"PHASE3","title":"Lubiprostone for Functional Constipation in the Under 18 Years Patients","status":"COMPLETED","sponsor":"Alexandria University","startDate":"2022-01-01","conditions":"Clinical Efficacy, Treatment Efficacy, Drug Side Effect","enrollment":274},{"nctId":"NCT04138004","phase":"PHASE4","title":"Colon Preparation With 2L PEG in Combination With Lubiprostone vs 4L PEG","status":"COMPLETED","sponsor":"Department of Medical Services Ministry of Public Health of Thailand","startDate":"2019-12-01","conditions":"Indication for Modification of Patient Status (Diagnosis)","enrollment":140},{"nctId":"NCT00746395","phase":"PHASE4","title":"Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy","status":"COMPLETED","sponsor":"University of South Alabama","startDate":"2008-04","conditions":"Inflammatory Bowel Disease","enrollment":45},{"nctId":"NCT02481947","phase":"PHASE3","title":"A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults","status":"COMPLETED","sponsor":"Braintree Laboratories","startDate":"2015-05","conditions":"Chronic Idiopathic Constipation","enrollment":459},{"nctId":"NCT02042183","phase":"PHASE3","title":"Lubiprostone in Children With Functional Constipation","status":"COMPLETED","sponsor":"Sucampo Pharma Americas, LLC","startDate":"2013-12-13","conditions":"Constipation - Functional","enrollment":606},{"nctId":"NCT02766777","phase":"PHASE3","title":"Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation","status":"COMPLETED","sponsor":"Sucampo Pharma Americas, LLC","startDate":"2016-04-12","conditions":"Constipation - Functional","enrollment":87},{"nctId":"NCT01298219","phase":"PHASE3","title":"Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)","status":"COMPLETED","sponsor":"Sucampo Pharma Americas, LLC","startDate":"2010-12","conditions":"Opioid-induced Bowel Dysfunction","enrollment":439},{"nctId":"NCT00620061","phase":"PHASE3","title":"Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone","status":"COMPLETED","sponsor":"Sucampo Pharma Americas, LLC","startDate":"2007-12","conditions":"Opioid-Induced Bowel Dysfunction","enrollment":439},{"nctId":"NCT02138136","phase":"PHASE3","title":"Lubiprostone for Children With Constipation","status":"COMPLETED","sponsor":"Sucampo Pharma Americas, LLC","startDate":"2014-02-26","conditions":"Constipation - Functional","enrollment":419},{"nctId":"NCT03097861","phase":"PHASE3","title":"Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo","status":"COMPLETED","sponsor":"Sucampo Pharma Americas, LLC","startDate":"2017-03-13","conditions":"Chronic Idiopathic Constipation","enrollment":552},{"nctId":"NCT00452335","phase":"PHASE4","title":"Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation","status":"COMPLETED","sponsor":"Sucampo Pharma Americas, LLC","startDate":"2007-01","conditions":"Constipation","enrollment":127},{"nctId":"NCT00595946","phase":"PHASE3","title":"Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone","status":"COMPLETED","sponsor":"Sucampo Pharma Americas, LLC","startDate":"2007-08","conditions":"Opioid-Induced Bowel Dysfunction","enrollment":439},{"nctId":"NCT00597428","phase":"PHASE3","title":"Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone","status":"COMPLETED","sponsor":"Sucampo Pharma Americas, LLC","startDate":"2007-08","conditions":"Opioid-Induced Bowel Dysfunction","enrollment":437},{"nctId":"NCT02729909","phase":"PHASE3","title":"Lubiprostone for Chronic Idiopathic Constipation Treatment","status":"COMPLETED","sponsor":"Takeda","startDate":"2016-05-11","conditions":"Constipation","enrollment":211},{"nctId":"NCT01190020","phase":"PHASE1","title":"Effect of Lubiprostone on Methanogenesis and Bowel Function in Chronic Constipation.","status":"COMPLETED","sponsor":"Augusta University","startDate":"2009-02","conditions":"Chronic Constipation, Methanogenesis","enrollment":41},{"nctId":"NCT02695719","phase":"PHASE3","title":"Lubiprostone for Treatment of Chronic Idiopathic Constipation","status":"COMPLETED","sponsor":"Takeda","startDate":"2016-04-14","conditions":"Chronic Idiopathic Constipation","enrollment":156},{"nctId":"NCT02651155","phase":"PHASE3","title":"Lubiprostone for the Treatment of Chronic Idiopathic Constipation","status":"COMPLETED","sponsor":"Takeda","startDate":"2016-03-02","conditions":"Constipation","enrollment":204},{"nctId":"NCT01460225","phase":"PHASE4","title":"Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation","status":"COMPLETED","sponsor":"Dartmouth-Hitchcock Medical Center","startDate":"2007-09","conditions":"Chronic Idiopathic Constipation","enrollment":19},{"nctId":"NCT00844831","phase":"PHASE4","title":"Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit","status":"COMPLETED","sponsor":"University of Louisville","startDate":"2009-05","conditions":"Constipation","enrollment":25},{"nctId":"NCT01469819","phase":"PHASE2, PHASE3","title":"Lubiprostone Effect on Gastrointestinal Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation","status":"COMPLETED","sponsor":"Texas Tech University Health Sciences Center, El Paso","startDate":"2012-06","conditions":"Chronic Idiopathic Constipation","enrollment":37},{"nctId":"NCT01447849","phase":"PHASE2, PHASE3","title":"Lubiprostone and Mucus Secretion in Patients With Chronic Constipation","status":"COMPLETED","sponsor":"Texas Tech University Health Sciences Center, El Paso","startDate":"2011-08","conditions":"Constipation","enrollment":40},{"nctId":"NCT01162863","phase":"NA","title":"Effects of Lubiprostone on Gastrointestinal Transit & pH in Irritable Bowel Syndrome (IBS) With Constipation","status":"COMPLETED","sponsor":"University of Michigan","startDate":"2010-11","conditions":"Irritable Bowel Syndrome, Constipation","enrollment":60},{"nctId":"NCT00669461","phase":"NA","title":"Lubiprostone as a Treatment for Constipation in Parkinson's Disease","status":"TERMINATED","sponsor":"University of Arkansas","startDate":"2009-06","conditions":"Constipation, Parkinson's Disease","enrollment":1},{"nctId":"NCT01170039","phase":"PHASE4","title":"The Effectiveness of Lubiprostone in Constipated Diabetics","status":"COMPLETED","sponsor":"Emory University","startDate":"2010-09","conditions":"Constipation, Diabetes","enrollment":121},{"nctId":"NCT01236534","phase":"PHASE4","title":"Lubiprostone in Patients With Multiple Sclerosis Associated Constipation","status":"COMPLETED","sponsor":"University of Rochester","startDate":"2010-11","conditions":"Multiple Sclerosis, Constipation","enrollment":21},{"nctId":"NCT00689026","phase":"NA","title":"Efficacy of Lubiprostone in Combination With Standard PEG Preparation","status":"TERMINATED","sponsor":"Augusta University","startDate":"2008-05","conditions":"Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2","enrollment":60},{"nctId":"NCT01674530","phase":"PHASE3","title":"Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2012-10","conditions":"Chronic Idiopathic Constipation","enrollment":909},{"nctId":"NCT00934479","phase":"PHASE1","title":"Intestinal Microecology in Chronic Constipation","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2010-04","conditions":"Other Constipation, Irritable Bowel Syndrome","enrollment":21},{"nctId":"NCT00662363","phase":"NA","title":"Lubiprostone (Amitiza®) Vs. Standard Care in Opioid-induced Constipation After Surgery in Inpatient Rehabilitation","status":"COMPLETED","sponsor":"Shirley Ryan AbilityLab","startDate":"2008-04","conditions":"Constipation","enrollment":64},{"nctId":"NCT01372423","phase":"PHASE3","title":"Evaluation of Clinical Equivalence Between Two Lubiprostone Products","status":"COMPLETED","sponsor":"Anchen Pharmaceuticals, Inc","startDate":"2011-05","conditions":"Chronic Idiopathic Constipation","enrollment":808},{"nctId":"NCT00953043","phase":"PHASE4","title":"Lubiprostone, Colonic Motility and Sensation","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2007-09","conditions":"Healthy","enrollment":60},{"nctId":"NCT00706004","phase":"NA","title":"Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis","status":"COMPLETED","sponsor":"University of Arkansas","startDate":"2008-07","conditions":"Constipation, Cystic Fibrosis","enrollment":9}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"ABDOMINAL PAIN"},{"count":1,"reaction":"FAECAL INCONTINENCE"}],"_approvalHistory":[],"publicationCount":24,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Amitiza"],"phase":"phase_3","status":"active","brandName":"Lubiprostone 24","genericName":"Lubiprostone 24","companyName":"Sucampo Pharma Americas, LLC","companyId":"sucampo-pharma-americas-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Lubiprostone is a ClC-2 chloride channel activator that increases intestinal fluid secretion and promotes bowel motility to relieve constipation. Used for Chronic idiopathic constipation, Irritable bowel syndrome with constipation (IBS-C), Opioid-induced constipation.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}