[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614308":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":240,"collaborators":25,"id":244,"slug":245,"hasResults":246,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":246,"sex":252,"minAge":253,"maxAge":25,"enrollmentInfo":254,"targetDuration":25,"studyType":257,"phases":258,"briefSummary":260,"conditions":261,"keywords":264,"overallStatus":91,"whyStopped":25,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":276},{"fullName":5,"class":6},"Third Military Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lubiprostone","EXPERIMENTAL","Lubiprostone is an oral bicyclic fatty acid that selectively activates type 2 chloride channels in the apical membrane of human gastrointestinal epithelial cells, thereby increasing chloride-rich fluid secretion. Although the mechanism is unclear, this may then decrease intestinal transit time, allowing the passage of stool and alleviating symptoms of constipation.",[13],"Drug: Lubiprostone",{"label":15,"type":16,"description":17,"interventionNames":18},"Polyethylene Glycol","ACTIVE_COMPARATOR","Polyethylene glycol (PEG ) is an established osmotic laxative, widely available worldwide for the treatment of functional constipation in adults and children.",[19],"Drug: Polyethylene glycol (PEG )",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Patients were instructed to orally ingest Lubiprostone Soft Capsules (provided by Nanjing Chia-Tai Tianqing Pharmaceutical Company) at a dose of 24 μg twice daily with food and water during breakfast and dinner. The capsules must be swallowed whole without splitting or chewing. The treatment duration was 4 weeks, and medication adherence was monitored through patient diaries and pill count of returned medication.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Polyethylene glycol (PEG )","Subjects in the control group will receive the standard treatment of polyethylene glycol 4000 powder at a dosage of 10 g, twice daily. Each dose will be dissolved in 200-250 mL of water and administered orally for 4 weeks.",[15],[31],{"name":32,"affiliation":33,"role":34},"Weidong Tong, MD","Army Medical Center (Daping Hospital)","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"yansen Huang, MS","CONTACT","8618630878656","1774651797@qq.com",[42,60,74,83,90,98,113,128,142,157,172,187,202,213,226],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Bishan Hospital of Chongqing","NOT_YET_RECRUITING","Bishan","Chongqing Municipality","402760","China","CN",{"type":51,"coordinates":52},"Point",[53,54],106.22476,29.59491,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":59,"phoneExt":25,"email":25},"Hong Chen, MD","13908366079",{"facility":61,"status":44,"city":62,"state":46,"zip":63,"country":48,"countryCode":49,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"the People's Hospital of HeChuan Chongqing","Hechuan","401533",{"type":51,"coordinates":65},[66,67],106.26461,29.99228,{"lat":67,"lon":66},[70],{"name":71,"role":38,"phone":72,"phoneExt":25,"email":73},"Fengbo Cai, MD","19332875137","linchuangyishi@163.com",{"facility":75,"status":44,"city":76,"state":46,"zip":77,"country":48,"countryCode":49,"cosmosGeoPoint":25,"geoPoint":25,"contacts":78},"Shapingba Hospital, Chongqing University","Shapingba","400033",[79],{"name":80,"role":38,"phone":81,"phoneExt":25,"email":82},"Jingwang Ye, MD","13206165509","yejingwang1977@qq.com",{"facility":84,"status":44,"city":76,"state":46,"zip":85,"country":48,"countryCode":49,"cosmosGeoPoint":25,"geoPoint":25,"contacts":86},"The Chenjiaqiao Hospital of ShaPingba District of Chongqing","401331",[87],{"name":88,"role":38,"phone":89,"phoneExt":25,"email":25},"Chuan Zhao, MD","13452949840",{"facility":33,"status":91,"city":92,"state":46,"zip":93,"country":48,"countryCode":49,"cosmosGeoPoint":25,"geoPoint":25,"contacts":94},"RECRUITING","Yuzhong","400042",[95],{"name":32,"role":38,"phone":96,"phoneExt":25,"email":97},"02368729356","vdtong@163.com",{"facility":99,"status":44,"city":100,"state":101,"zip":102,"country":48,"countryCode":49,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Gansu Province Central Hospital","Lanzhou","Gansu","730079",{"type":51,"coordinates":104},[105,106],103.83987,36.05701,{"lat":106,"lon":105},[109],{"name":110,"role":38,"phone":111,"phoneExt":25,"email":112},"Feng Gao, MD","13919763019","gaofeng994512@163.com",{"facility":114,"status":44,"city":115,"state":116,"zip":117,"country":48,"countryCode":49,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"The First Affiliated Hospital of Harbin Medical University","Harbin","Heilongjiang","150007",{"type":51,"coordinates":119},[120,121],126.65,45.75,{"lat":121,"lon":120},[124],{"name":125,"role":38,"phone":126,"phoneExt":25,"email":127},"Anlong Zhu, MD","13504848555","zhuanlone@163.com",{"facility":129,"status":44,"city":130,"state":131,"zip":132,"country":48,"countryCode":49,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Zhongnan Hospital of Wuhan University","Wuhan","Hubei","430062",{"type":51,"coordinates":134},[135,136],114.26667,30.58333,{"lat":136,"lon":135},[139],{"name":140,"role":38,"phone":25,"phoneExt":25,"email":141},"Congqing Jiang, MD","wb002554@whu.edu.cn",{"facility":143,"status":44,"city":144,"state":145,"zip":146,"country":48,"countryCode":49,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"General Hospital of the Eastern Theater Cammand of the PLA","Nanjing","Jiangsu","210002",{"type":51,"coordinates":148},[149,150],118.77778,32.06167,{"lat":150,"lon":149},[153],{"name":154,"role":38,"phone":155,"phoneExt":25,"email":156},"Jun Jiang, MD","13809021165","jiangjun6987@163.com",{"facility":158,"status":44,"city":159,"state":160,"zip":161,"country":48,"countryCode":49,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Renji Hospital, Shanghai Jiaotong University","Pudong","Shanghai Municipality","200127",{"type":51,"coordinates":163},[164,165],121.50094,31.23995,{"lat":165,"lon":164},[168],{"name":169,"role":38,"phone":170,"phoneExt":25,"email":171},"Zhe Cui, MD","13512177595","cuizhe@renji.com",{"facility":173,"status":44,"city":174,"state":175,"zip":176,"country":48,"countryCode":49,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Xijing Hospital","Xi’an","Shanxi","710032",{"type":51,"coordinates":178},[179,180],113.52486,35.99785,{"lat":180,"lon":179},[183],{"name":184,"role":38,"phone":185,"phoneExt":25,"email":186},"Jianyong Zheng, MD","13891835899","zhjy68@163.com",{"facility":188,"status":44,"city":189,"state":190,"zip":191,"country":48,"countryCode":49,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Chengdu Analrectal Hospital","Chengdu","Sichuan","610017",{"type":51,"coordinates":193},[194,195],104.06667,30.66667,{"lat":195,"lon":194},[198],{"name":199,"role":38,"phone":200,"phoneExt":25,"email":201},"Haibo Lan, MD","15902820940","937355963@qq.com",{"facility":203,"status":44,"city":189,"state":190,"zip":204,"country":48,"countryCode":49,"cosmosGeoPoint":205,"geoPoint":207,"contacts":208},"The General Hospital of Western Theater Command","610036",{"type":51,"coordinates":206},[194,195],{"lat":195,"lon":194},[209],{"name":210,"role":38,"phone":211,"phoneExt":25,"email":212},"Lin Zhang, MD","13880526971","flysky8026@aliyun.com",{"facility":214,"status":44,"city":215,"state":190,"zip":216,"country":48,"countryCode":49,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"The Second People's Hospital of Yibin","Yibin","644000",{"type":51,"coordinates":218},[219,220],104.63994,28.7593,{"lat":220,"lon":219},[223],{"name":224,"role":38,"phone":225,"phoneExt":25,"email":201},"Miao Wu, MD","13990905852",{"facility":227,"status":44,"city":228,"state":229,"zip":230,"country":48,"countryCode":49,"cosmosGeoPoint":231,"geoPoint":235,"contacts":236},"Zhejiang Provincial People's Hospital","Hangzhou","Zhejiang","310014",{"type":51,"coordinates":232},[233,234],120.16142,30.29365,{"lat":234,"lon":233},[237],{"name":238,"role":38,"phone":25,"phoneExt":25,"email":239},"Wenjing Gong, MD","gongwenjing@vip.163.com",{"type":241,"investigatorFullName":242,"investigatorTitle":243,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Weidong Tong","Director","100614308","phase-3-efficacy-and-safety-of-lubiprostone-in-the-treatment-of-slow-transit-constipation-100614308",false,"NCT07277907","Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation","Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation: A Multicenter, Randomized Controlled Trial","STOPS 03","Inclusion Criteria:\n\n1. Patients voluntarily participated in the study and provided signed informed consent;\n2. Met the Rome IV diagnostic criteria for functional constipation;\n3. Had fewer than 3 spontaneous bowel movements (SBMs) per week;\n4. More than 20% the radio-paque markers localized in the colon after 72 hours based on colonic transit studies;\n5. Were able to complete the bowel movement diary and study questionnaires as required by the study protocol;\n6. Agreed to use effective contraception from the time of signing the informed consent form until 3 months after the last dose of the study drug;\n7. Aged 18 years or older, both males and females.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Patients with severe outlet obstruction constipation (e.g. Oxford Grade IV or above for rectal prolapse, rectocele \\> 3.1 cm, puborectalis syndrome).\n3. Patients with hyperthyroidism or hypothyroidism.\n4. Patients with opioid-induced constipation.\n5. Patients with megacolon or megarectum.\n6. Patients with apparent mechanical intestinal obstruction.\n7. Patients with inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis).\n8. Patients with malignant tumors of the digestive system.\n9. Patients with a history of colorectal surgery.\n10. Patients with a previous history of taking lubiprostone.\n11. Patients with severe symptoms of depression or anxiety.\n12. Patients with known or suspected hypersensitivity to lubiprostone\u002Fpolyethylene glycol 4000 or any excipients.\n13. Patients requiring medications for Parkinson's disease, antipsychotics, antimanic agents, or psychostimulants.\n14. Patients with severe cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, neurological, or psychiatric diseases.\n15. Other patients deemed by the investigator as unsuitable for participation in this trial.","ALL","18 Years",{"count":255,"type":256},346,"ESTIMATED","INTERVENTIONAL",[259],"PHASE3","Lubiprostone has established efficacy and a favorable safety profile in chronic constipation and irritable bowel syndrome with constipation (IBS-C). However, clinical data specifically supporting its use in slow-transit constipation (STC), a distinct subtype of chronic constipation, remains limited.",[262,263],"Slow Transit Constipation","Pharmacotherapy",[262,9,15,265,266],"Randomized Controlled Trial","medication","2026-01-16",{"date":269,"type":270},"2026-01-20","ACTUAL",{"date":272,"type":270},"2025-11-13",{"date":274,"type":256},"2027-11-30",{"name":5,"class":6},15]