[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-idiopathic-constipation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-idiopathic-constipation":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100626155","phase-4-efficacy-and-safety-of-linaclotide-in-chronic-constipation-100626155",false,"NCT07431957","\"Efficacy and Safety of Linaclotide in Chronic Constipation\"","\"Efficacy and Safety of Linaclotide in Chronic Constipation : A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study\"","LIN-CC-BD","Inclusion Criteria:\n\n* Adult patients (18-70 years)\n* patients diagnosed with CIC or IBS-C based on Rome IV criteria\n* No abnormal finding on colonoscopy conducted within past 1 year\n* Patients who can read and are willing to complete daily bowel diary and follow study procedures\n\nExclusion Criteria:\n\n* Clinical features suggestive of organic disease ( Anaemia, unexplained weight loss, per rectal bleeding, family history of malignancy)\n* Secondary constipation due to structural, metabolic, or neurological causes (IBD, Colorectal cancer, hypothyroidism, hypercalcemia, DM, Parkinson's disease)\n* History of or new onset intestinal obstruction\n* Prior history of stomach, small intestine and colorectal surgery ( except appendectomy or hemorroidectomy)\n* Patients currently suffering from medication induced costipation ( opioids, anti choline raids, calcium channel blockers, oral iron and calcium supplements, anti-Parkinsonian drug, antipsychotic, anti-emetics or psychostimulant drugs)\n* Use of medication affecting bowel motility ( Lubiprostone, Elobixibat, PEG or prosecretory agents) within 2 week before enrollment\n* Serious cardiovascular, respiratory, renal, GI, hepatic, hematological, neurological or psychiatric illness\n* Pregnancy or lactation","ALL","18 Years","70 Years",{"count":21,"type":22},90,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Goal of this study is to evaluate the efficacy and safety of two different doses of Linaclotide in improving bowel function and patient-reported outcomes among Bangladeshi patients with chronic constipation for 8 weeks along with an additional short drug-free follow up period of 2 weeks. The main question it aims to answer is \"Does Linaclotide at doses of 72microgram or 145microgram once daily improve bowel function and patient-reported coutcomes compared with placebo in Bangladeshi patients with chronic constipation over an 8-week treatment period?\"\n\nStudy procedure:\n\nFrom outpatient department of Gastroenterology, Dhaka Medical College, a total of 90 adult patients diagnosed with chronic idiopathic constipation (CIC) or constipation predominant irritable bowel syndrome (IBS-C) by ROME-IV criteria will be selected after baseline evaluation including clinical history, physical examination, laboratory tests and colonoscopy. Before enrollment eligible participants will undergo 1-week baseline stool diary which will include baseline data of patient reported severity of abdominal symptoms (bowel movement, stool frequency, bloating, abdominal pain or discomfort and defecatory satisfaction score). Patients reporting more than 3 SBMs during baseline run in period will be excluded from the study. Finally total 90 patients will be enrolled as participants who will be randomly assigned to one of the three groups, Group A (Linaclotide 72mcg once daily), Group B (Linaclotide 145mcg once daily) and Group C (Placebo once daily ). The treatment period will start from randomization visit (day 0) and will be continued for 8 weeks. All participants will receive identical looking drugs (72mcg or 145mcg or placebo) 30 minutes before breakfast and they will be requested to maintain standard dietary and lifestyle advices including increased intake of high fiber diet and fluid throughout the study. Patients will record spontaneous bowel movement (SBM) and complete spontaneous bowel movement (CSBM), stool consistency using Bristol Stool Form Scale (BSFS), severity of abdominal symptoms by 5-point Likert scale, use of rescue medication after 3 days of absolute constipation and adverse events such as diarrhea in their daily stool diary. They will be followed up at week-4, week-8 and after 2-week drug free withdrawal period at week-10 with review of stool diary and safety assessments. Entire study will be monitored by Data Safety Monitoring Board (DSMB) of Dhaka Medical College.",[28,29,30,31,32],"Chronic Idiopathic Constipation","Irritable Bowel Syndrome (IBS-C)","Chronic Constipation","CIC","Constipation Predominant Irritable Bowel Syndrome",[34,31,35,36,37,38,39,15,40,29],"CC","IBS-C","Chronic Constipation (CC)","Chronic Idiopathic Constipation (CIC)","Constipation predominant Irritable Bowel Syndrome (IBS-C)","Linaclotide","Linaclotide RCT","NOT_YET_RECRUITING","2026-02-21",{"date":44,"type":45},"2026-02-25","ACTUAL",{"date":47,"type":22},"2026-02-20",{"date":49,"type":22},"2027-01-31",{"name":51,"class":52},"Md Mehedi Shahriar","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":17,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":53},"100572718","phase-1-this-study-aims-to-evaluate-the-safety-tolerability-pharmacokinetic-and-pharmacodynamic-properties-and-food-effect-of-in-114199-in-healthy-participants-100572718","NCT06736912","This Study Aims to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties and Food Effect of IN-114199 in Healthy Participants","A Randomized, Double-blind, Placebo-controlled, Single\u002Fmultiple Dosing, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety\u002Ftolerability, Pharmacokinetic\u002Fpharmacodynamic Characteristics and Food Effect After Oral Administration of IN-114199 in Healthy Participants","Inclusion Criteria:\n\n* Healthy adults aged ≥ 19 years and ≤ 63 years on the date of the written informed consent\n* Healthy subjects were defined as individuals who defecated almost every day for ≥ 6 months\n* Body weight of ≥ 40.0 kg and ≤ 100.0 kg, with body mass index (BMI) of ≥ 18.5 kg\u002Fm2 and ≤ 29.9 kg\u002Fm2 at the time of screening\n* Those who have fully understood this clinical trial via detailed explanation, were willing to voluntarily participate in this study, and agreed to give written informed consent prior to the screening procedure.\n* Those who are judged eligible for this study upon judgment of the investigator in screening tests established depending on the characteristics of investigational product (examinations by interview, clinical laboratory test, physical examinations, etc.).\n\nExclusion Criteria:\n\n* Presence or history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, cardiovascular system, urinary system or psychiatric disease\n* Presence or history of gastrointestinal disorder (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) that may influence the safety and pharmacodynamic assessments of the investigational product and history of gastrointestinal surgery (except simple appendectomy and hernia surgery), hemostatic disorder or hemorrhage-related disease\n* Hypersensitivity to drugs including the ingredients of the investigational product and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity\n* Positive result in serology tests (Hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)\n* Subjects who have history of drug abuse, or who have a positive urine test for drugs of abuse.\n* Blood AST(SGOT), and ALT(SGPT) \\> 60 IU\u002FL at the screening test\n* Showing the following findings on ECG at the screening test: QT \\> 480 msec(all), QTcB\\>450(male), QTcB\\>470(female)\n* Subjects who have taken any drugs known to significantly induce (e.g., barbiturates) or inhibit drug-metabolizing enzymes within 1 month prior to the expected initial application date.\n* Subjects who have participated in other clinical trials within 6 months prior to the expected initial application date\n* Subjects who have history of regular alcohol consumption exceeding 21 units\u002Fweek (1 unit = 10 g = 12.5 mL of pure alcohol) or subjects who cannot avoid drinking alcohol from 3 days prior to the expected initial application date to the discharge\n* Subjects who have history of average use of 10 cigarettes daily\n* Subjects who consumed caffeine-containing food (coffee, green tea, black tea, carbonated beverage, coffee-flavored milk, tonics, etc.) or subjects who cannot avoid drinking caffeine-containing food from 3 days prior to the expected initial application date to the discharge\n* Subjects are unable to use a highly effective method of contraception (e.g., correctly placed intrauterine device(IUD), sterilization surgery (vasectomy, tubal ligation, etc.))\n* Subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion\u002Fexclusion criteria.",true,"19 Years","63 Years",{"count":65,"type":22},80,[67],"PHASE1","This study aims to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties and food effect of IN-114199 in healthy participants",[28],"2024-12-15",{"date":72,"type":45},"2024-12-17",{"date":74,"type":22},"2024-12-16",{"date":76,"type":22},"2025-11-11",{"name":78,"class":79},"HK inno.N Corporation","INDUSTRY"]