[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606868":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":31,"locations":32,"responsibleParty":43,"collaborators":31,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":31,"enrollmentInfo":56,"targetDuration":31,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":72,"whyStopped":31,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Mather's Pharm. Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Test Drug Group","EXPERIMENTAL","2-day split-dose",[13],"Drug: MSP01-T",{"label":15,"type":16,"description":11,"interventionNames":17},"Control Drug Group","ACTIVE_COMPARATOR",[18],"Drug: MSP01-R",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","MSP01-R","Total 20 tablets, split-dose administration over 2 days: 14 tablets the day before colonoscopy, 14 tablets on the morning of colonoscopy, oral intake.",[15],[26],"Orafang Tab",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"MSP01-T","Total 20 tablets, split-dose administration over 2 days: 10 tablets the day before colonoscopy, 10 tablets on the morning of colonoscopy, oral intake.",[9],null,[33],{"facility":34,"status":31,"city":35,"state":31,"zip":31,"country":36,"countryCode":31,"cosmosGeoPoint":37,"geoPoint":42,"contacts":31},"Kangbuk Samsung Hospital","Seoul","South Korea",{"type":38,"coordinates":39},"Point",[40,41],126.9784,37.566,{"lat":41,"lon":40},{"type":44,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100606868","phase-3-a-study-to-evaluate-the-safety-and-effectiveness-of-msp01-t-for-bowel-cleansing-before-a-colonoscopy-100606868",false,"NCT07181148","A Study to Evaluate the Safety and Effectiveness of MSP01-T for Bowel Cleansing Before a Colonoscopy","A Prospective, Randomized, Single-blinded (Investigator), Parallel, Multi-center, Active-control, Non-inferiority, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of MSP01-T for Bowel Cleansing Before Colonoscopy","MSP01","Inclusion Criteria:\n\n1. Male or female participants aged 19 years or older at the time of providing written informed consent.\n2. Individuals scheduled to undergo a screening colonoscopy.\n3. 19 kg\u002F㎡ ≤ BMI \\\u003C 30 kg\u002F㎡\n4. Participants who have voluntarily agreed to participate in the clinical trial and have provided written informed consent.\n\nExclusion Criteria:\n\nParticipants who meet any of the following will NOT be eligible to participate in this clinical trial:\n\n1. Colonoscopy for therapeutic purposes, including:\n\n   * Hemostatic treatment after vascular malformation, ulcer, tumor, or polypectomy\n   * Decompression for non-toxic megacolon or sigmoid volvulus\n   * Foreign body removal\n   * Balloon dilation of strictures\n   * Palliative treatment for bleeding due to strictures or tumors\n2. Medical history at screening, including:\n\n   * Epilepsy or seizure within 2 years\n   * Severe cardiac disease within 24 weeks (e.g., unstable angina, acute myocardial infarction)\n   * Clinically significant gastrointestinal or abdominal surgery within 24 weeks (except appendectomy, hemorrhoidectomy)\n   * Active infection or fever ≥ 38°C within 1 week (except mild upper respiratory infection or localized skin infection)\n   * Hypersensitivity to investigational product components\n3. Concomitant diseases at screening, including:\n\n   * Active gastrointestinal bleeding\n   * Coagulation disorders\n   * Gastrointestinal obstruction, perforation, or gastric emptying disorders\n   * Inflammatory bowel disease (e.g., Crohn's disease, toxic megacolon, toxic colitis)\n   * Acute abdomen requiring surgery\n   * Major cardiovascular disease (e.g., congestive heart failure \\[NYHA class III-IV\\], clinically significant arrhythmia, QTcF \\> 450 msec \\[male\\] or \\> 470 msec \\[female\\])\n   * Uncontrolled hypertension (systolic blood pressure \\> 170 mmHg or diastolic blood pressure \\> 100 mmHg)\n   * Insulin therapy requirement\n   * Clinically significant electrolyte imbalance\n   * Risk of dehydration (e.g., rhabdomyolysis, ascites)\n   * Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²)\n   * ALT or AST \\> 3 × ULN\n   * Severe nausea or vomiting interfering with trial participation\n   * Active hepatitis B (HBsAg positive) or hepatitis C (HCV Ab positive)\n   * HIV positive\n   * Neurological or psychiatric disorders (e.g., depression, bipolar disorder, epilepsy, substance abuse) or use of related medications\n4. Medication use:\n\n   * Severe constipation (bowel movement \\\u003C 3\u002Fweek) or regular use of laxatives\u002Fprokinetics within 12 weeks\n   * Use of laxatives, enemas, simethicone, 5-HT4 agonists, iron, or opioids within 7 days before Day 1\n5. Pregnant or breastfeeding women\n6. Women of childbearing potential and men unwilling to use effective contraception during the study\n7. Participation in another clinical trial and receipt of investigational drug or device within 4 weeks\n8. Any condition judged inappropriate by the investigator",true,"ALL","19 Years",{"count":57,"type":58},214,"ESTIMATED","INTERVENTIONAL",[61],"PHASE3","This study is being conducted to evaluate the safety and effectiveness of MSP01-T, a new bowel cleansing agent, in adults who are scheduled to undergo a colonoscopy.\n\nParticipants will be randomly assigned to receive either MSP01-T or a comparator product.\n\nThe study will assess how effectively MSP01-T cleans the bowel before the procedure and monitor any potential side effects.\n\nAdults aged 19 years and older who are planning to have a colonoscopy may be eligible to take part.",[64,65],"Colonoscopy","Bowel Preparation",[28,64,67,68,69,70,71],"Colon Cleanse","Oral Bowel Cleanser","Oral Tablet","Randomized Trial","Phase 3 Study","NOT_YET_RECRUITING","2025-09-24",{"date":75,"type":76},"2025-09-25","ACTUAL",{"date":78,"type":58},"2025-10",{"date":80,"type":58},"2026-05",{"name":5,"class":6},1]