[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mather's Pharm. Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":105},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100639619","phase-4-phase-4-study-of-sto-m-tab-in-acute-or-chronic-gastritis-100639619",false,"NCT07631065","Phase 4 Study of Sto M Tab. in Acute or Chronic Gastritis","A Randomized, Double-blinded, Active Controlled, Non-Inferiority, Multicenter, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Sto M Tab. in Patients With Acute or Chronic Gastritis","Inclusion Criteria:\n\n1. Male or female adults aged 19 to 75 years at the time of screening.\n2. Participants diagnosed with acute or chronic gastritis by upper gastrointestinal endoscopy performed within 7 days prior to randomization (Visit 2), with at least one gastric erosion confirmed. Erosions of the esophagus and duodenum are excluded.\n3. Female participants of childbearing potential or male participants who agree to maintain sexual abstinence or use appropriate contraceptive methods during the study period and for 2 weeks after the last administration of the investigational product. Periodic abstinence, such as calendar, ovulation, symptothermal, or post-ovulation methods, is not considered an acceptable contraceptive method.\n4. Participants who voluntarily provide written informed consent to participate in this clinical trial.\n\nExclusion Criteria:\n\n1. Participants with any of the following lesions confirmed or accompanied by upper gastrointestinal endoscopy at screening (Visit 1): active or healing peptic ulcer; reflux esophagitis; Barrett's esophagus greater than 3 cm; gastroesophageal varices; esophageal stricture; or other clinically relevant lesions. Participants with ulcer scars may be enrolled.\n2. Participants who have a history of gastric acid secretion-inhibiting surgery or gastric or esophageal surgery at screening (Visit 1).\n3. Participants who have been diagnosed with or have a history of Zollinger-Ellison syndrome at screening (Visit 1).\n4. Participants with inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or intestinal Behcet's disease; primary esophageal motility disorder; or pancreatitis at screening (Visit 1).\n5. Participants with a history of malignancy within 5 years prior to screening (Visit 1). However, participants who have been completely treated and have had no recurrence for at least 5 years may be enrolled at the investigator's discretion. Participants with gastrointestinal malignancy are excluded regardless of the time since diagnosis. Participants with basal cell carcinoma, squamous cell carcinoma of the skin, thyroid cancer, or carcinoma in situ of other sites may be enrolled at the investigator's discretion if they have been completely treated and have had no recurrence for at least 3 years.\n6. Participants with current or prior thrombotic disease at screening (Visit 1), such as cerebral thrombosis, myocardial infarction, thrombophlebitis, or venous thrombosis.\n7. Participants diagnosed with disseminated intravascular coagulation at screening (Visit 1).\n8. Participants with concomitant hepatic, renal, cardiac, pulmonary, hematologic, or other diseases that, in the investigator's judgment, may affect the efficacy or safety evaluations.\n9. Participants with current or prior lipid metabolism disorders at screening (Visit 1), such as hyperlipidemia or diabetic hyperlipidemia, or participants who require cautious administration of lipid nutritional products. However, participants whose condition is adequately controlled with medication may be enrolled at the investigator's discretion.\n10. Participants with hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.\n11. Participants with a history of hypersensitivity to soybean, peanut, or soybean oil.\n12. Participants with a history of hypersensitivity to any component of the investigational products, such as tartrazine.\n13. Participants with clinically significant psychiatric disease at screening (Visit 1).\n14. Participants who meet any other exclusion criteria related to prior or concomitant medications specified in the protocol.","ALL","19 Years","75 Years",{"count":20,"type":21},470,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This Phase 4, multicenter, randomized, double-blind, active-controlled, non-inferiority study aims to evaluate the non-inferiority of Stoem Tab. compared to Stillen Tab. (Dong-A ST Co., Ltd.) in patients with acute or chronic gastritis. Participants will receive either Stoem Tab. or Stillen Tab. for 2 weeks. The primary outcome is the effective rate of gastric mucosal erosion at Week 2, assessed by upper gastrointestinal endoscopy and evaluated by an independent reviewer, defined as the proportion of participants achieving at least a 50% improvement in erosion score compared to baseline.",[27,28,29],"Gastritis","Acute Gastritis","Chronic Gastritis","NOT_YET_RECRUITING","2026-06-01",{"date":33,"type":34},"2026-06-05","ACTUAL",{"date":36,"type":21},"2026-06",{"date":38,"type":21},"2028-02",{"name":40,"class":41},"Mather's Pharm. Co., Ltd.","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100608591","phase-4-phase-4-study-of-laybon-tab-in-knee-osteoarthritis-100608591","NCT07203547","Phase 4 Study of Laybon Tab. in Knee Osteoarthritis","Multicenter, Randomized, Double-blind, Active Control, Parallel, Non-inferior, Phase 4 Clinical Trial to Assess Efficacy and Safety of Laybon Tab. in Patients With Knee Osteoarthritis","Inclusion Criteria:\n\n1. Adults aged 40 to 80 years, male or female.\n2. Diagnosed with unilateral or bilateral knee osteoarthritis according to the American College of Rheumatology (ACR) clinical criteria, meeting at least 3 of the following:\n\n   * Age \\> 50 years\n   * Morning stiffness \\\u003C 30 minutes\n   * Crepitus\n   * Bony tenderness\n   * Bony enlargement\n   * No warmth on palpation\n3. Knee osteoarthritis pain persisting for at least 3 months and requiring pharmacologic treatment at screening.\n4. Kellgren-Lawrence grade 1-3 on knee X-ray at screening.\n5. Knee pain during activity over the past 24 hours ≤ 80 mm on 100 mm pain VAS at screening.\n6. Knee pain during activity over the past 24 hours ≥ 40 mm on 100 mm pain VAS at baseline (Visit 2).\n7. Able to walk without assistance (walker, cane, etc.). Participants who have routinely used mobility aids for at least 6 months prior to screening may continue their usual aid throughout the study.\n8. Women of childbearing potential and men must agree to use medically acceptable contraception during the study, including hormonal contraception, IUD\u002FIUS, bilateral tubal ligation, partner vasectomy, or sexual abstinence.\n9. Participants currently receiving treatment for knee osteoarthritis must agree to discontinue prior therapies and comply with a wash-out period before and during study participation\n10. Participants must have received and understood a full explanation of the study and voluntarily provided written informed consent.\n11. Women of childbearing potential must have a negative pregnancy test prior to study drug administration.\n\nExclusion Criteria:\n\n1. Screening BMI ≥ 35.0 kg\u002Fm².\n2. Presence of other joint disorders or systemic conditions that could affect safety or efficacy assessments, including:\n\n   * Rheumatoid arthritis, autoimmune diseases, septic arthritis, inflammatory joint diseases, gout, recurrent pseudogout, joint fracture, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondrodysplasia, genetic disorders (e.g., hypermobility), or secondary osteoarthritis\n   * Severe osteoarthritis of hip or other joints interfering with knee evaluation\n   * Painful conditions such as Sudeck's atrophy, Paget's disease, spinal disc herniation\n   * Active or suspected infection in the target knee\n3. History of the following conditions at screening:\n\n   * Upper gastrointestinal ulcer within 6 months, GI bleeding within 12 months, or gastrointestinal disorders affecting drug absorption\n   * Severe cardiovascular diseases (NYHA class ≥3, ischemic heart disease, arrhythmia, peripheral vascular disease, prior coronary interventions, cerebrovascular disorders)\n   * Severe liver impairment (ALT or AST \\> 3× ULN)\n   * Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin)\n   * Bronchial asthma\n   * Fluid retention\n   * Lipid metabolism disorders (hyperlipidemia, diabetic dyslipidemia, pancreatitis)\n   * Active systemic infection or viral infection (HCV, HBV)\n   * Malignancy, except those in complete remission ≥5 years or certain completely treated cancers (basal cell carcinoma, squamous cell carcinoma, thyroid papillary carcinoma, cervical carcinoma in situ)\n4. Current use of psychotropic medications.\n5. History of knee interventions prior to study drug administration:\n\n   * Cell or gene therapy, autologous bone marrow stem cell therapy within 5 years\n   * Knee ligament surgery, cartilage graft, osteotomy within 1 year\n   * Arthroscopy within 6 months\n   * Intra-articular injections (HA, PN, PDRN, PRP, collagen, dextrose\u002Fprolotherapy) within 6 months\n   * Steroid injections, other anti-inflammatory injections, unknown knee medications within 3 months\n   * Continuous opioid use ≥1 week within 3 months\n   * Systemic steroids (excluding inhaled) or anticonvulsants within 1 month\n   * Prior knee joint replacement\n6. Individuals who have received the following medications or therapies for the purpose of controlling pain or improving symptoms in the knee joint or other conditions prior to study drug administration and who are unable to discontinue these treatments during participation in the clinical trial, or who have additional treatments planned. (However, subjects may participate in the study after a 2-week wash-out period prior to study drug administration \\[Visit 2\\]. Low-dose aspirin up to 100 mg per day is permitted; the use of acetaminophen provided as rescue medication is allowed within the permitted dose, except within 48 hours prior to Visits 3 and 4.)\n\n   * Acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), and other analgesics.\n   * Topical anti-inflammatory drugs for knee application (NSAID gel, cream, patch, etc.) or topical analgesics (including muscle pain relievers containing capsaicin, menthol, camphor, etc.).\n   * Other therapies (e.g., physical therapy, oriental medicine such as acupuncture, cupping, and moxibustion).\n   * Nutritional supplements for osteoarthritis (e.g., glucosamine, chondroitin, methylsulfonylmethane \\[MSM\\], boswellia, etc.).\n7. Known hypersensitivity to study drug or rescue medications or their components.\n8. History of allergy or hypersensitivity to COX-2 inhibitors, sulfonamides, aspirin, or other NSAIDs.\n9. Pregnant or breastfeeding women.\n10. Known allergy or hypersensitivity to soybean oil.\n11. Known allergy or hypersensitivity to peanuts or legumes.\n12. History of drug or alcohol abuse within 1 year prior to study drug administration.\n13. High-risk alcohol consumption (≥2 times\u002Fweek and ≥7 drinks per occasion for men, ≥5 for women).\n14. Prior use of Layla Tab., Laybon Tab., or any herbal\u002Fextract product containing the same components (e.g., 25% ethanol extract of listed herbs) within the past 4 weeks (wash-out required).\n15. Participation in another clinical trial or use of investigational medical device within 1 month prior to screening.\n16. Unable to understand or provide informed consent as judged by the investigator.\n17. Any other reason the investigator considers the participant unsuitable for study participation.","40 Years","80 Years",{"count":52,"type":21},172,[24],"This Phase 4, multicenter, randomized, double-blind, active-controlled, parallel study aims to evaluate the non-inferiority of Laybon Tab. compared to Layla Tab. (PMG Pharm Co., Ltd.) in patients with knee osteoarthritis. Participants will receive either Laybon Tab. or Layla Tab. for 8 weeks. The primary outcome is the change in knee pain during activity, assessed by a 100 mm pain VAS over the previous 24 hours.",[56,57],"Osteoarthritis, Knee","Osteoarthritis",[59,60,57,61,62,63,64,65],"Laybon Tab.","Knee Osteoarthritis","OA","Non-inferiority","Randomized Trial","Double blind","Phase 4","2025-09-24",{"date":68,"type":34},"2025-10-02",{"date":70,"type":21},"2025-12",{"date":72,"type":21},"2028-03",{"name":40,"class":41},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100606868","phase-3-a-study-to-evaluate-the-safety-and-effectiveness-of-msp01-t-for-bowel-cleansing-before-a-colonoscopy-100606868","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,{"count":84,"type":21},214,[86],"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.",[89,90],"Colonoscopy","Bowel Preparation",[92,89,93,94,95,63,96],"MSP01-T","Colon Cleanse","Oral Bowel Cleanser","Oral Tablet","Phase 3 Study",{"date":98,"type":34},"2025-09-25",{"date":100,"type":21},"2025-10",{"date":102,"type":21},"2026-05",{"name":40,"class":41},1,""]