[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heartburn\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heartburn":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,79,103,136],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100641615","antireflux-surgery-without-preoperative-esophageal-manometry-100641615",false,"NCT07659080","Antireflux Surgery Without Preoperative Esophageal Manometry","Laparoscopic Toupet Fundoplication With or Without Preoperative Esophageal Manometry in Patients With GERD and Hiatal Hernia","NOMA","Inclusion Criteria\n\n1. Age ≥ 18 years\n2. Documented GERD and\u002For hiatal hernia (Type I, II, or small Type III) confirmed on EGD and\u002For imaging (i.e. CT scan or upper GI study) within 12 months\n3. Presence of at least one guideline-based indication for antireflux surgery:\n\n   1. Typical GERD symptoms (heartburn and\u002For regurgitation) refractory to or recurrent after adequate PPI therapy\n   2. PPI-dependent GERD with patient preference for surgical management\n   3. Extra-esophageal GERD symptoms (chronic cough, laryngitis, asthma) with pathologic reflux confirmed on ambulatory pH study\n   4. Symptomatic Type II\u002FIII paraesophageal hernia (postprandial pain, early satiety, dysphagia to solids)\n   5. Objective documentation of pathologic esophageal acid exposure on ambulatory reflux monitoring (24-hour pH-impedance or 48-hour Bravo pH capsule) confirming GERD diagnosis, performed within 12 months of enrollment\n4. Mellow-Pinkas dysphagia score = 0 at baseline (no overt dysphagia)\n5. Eckardt score \\\u003C 1 (achalasia screening)\n6. Ability to provide informed consent and comply with 12-month follow-up.\n\nExclusion Criteria:\n\n1. Overt dysphagia (Mellow-Pinkas ≥ 1 or Eckardt ≥ 1)\n2. Prior esophageal or gastric surgery\n3. Known or clinically suspected achalasia or primary motility disorder\n4. Endoscopic stricture, mass, or luminal obstruction\n5. Giant paraesophageal hernia (Type IV, or Type III with \\>50% of stomach herniated intrathoracically)\n6. Connective tissue disease with esophageal involvement (e.g., scleroderma\u002FCREST)\n7. Active esophageal or gastric malignancy\n8. Pregnancy\n9. BMI \\> 40 kg\u002Fm² (patients with severe obesity who would be candidates for bariatric surgery should be referred for metabolic\u002Fbariatric evaluation, as per the multi-society GERD guideline recommending weight-loss surgery consideration in this population)\n10. Participation in another interventional trial within 30 days\n11. Prior esophageal manometry within 12 months demonstrating a major motility disorder (achalasia, absent contractility, distal esophageal spasm, hypercontractile esophagus); such patients should be managed per standard motility disorder pathways and are not candidates for this trial.","ALL","18 Years",{"count":20,"type":21},96,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn if people can safely skip a test called esophageal manometry before surgery for acid reflux (gastroesophageal reflux disease, or GERD) or a hiatal hernia. Manometry measures the muscles of the food pipe using a thin tube passed through the nose. The test can be uncomfortable and can delay surgery. The main questions this study aims to answer are whether people can skip manometry and still have good swallowing one year after surgery, and whether skipping the test lowers discomfort, shortens the wait for surgery, and lowers cost. To answer this, researchers will compare two groups. One group will have surgery without manometry. The other group will have manometry first, the way it is usually done. Everyone will get the same operation, a partial wrap called a Toupet fundoplication, so the study tests the value of the test and not the surgery. Participants will be placed by chance into one of the two groups, have the same standard operation, and fill out short questionnaires about their swallowing before surgery and again at 3, 6, and 12 months after surgery. Researchers want to find out if skipping manometry works just as well as the usual approach for people who do not have trouble swallowing before surgery.",[27,28,29,30,31],"GERD","Hiatal Hernia","Heartburn","Paraesophageal Hernia","Gastroesophageal Reflux",[27,33,34,35,30],"hiatal hernia","fundoplication","Gastroesophageal Reflux Disease","NOT_YET_RECRUITING","2026-06-16",{"date":39,"type":40},"2026-06-22","ACTUAL",{"date":42,"type":21},"2026-10-01",{"date":44,"type":21},"2028-04-30",{"name":46,"class":47},"McMaster University","OTHER",2,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100185996","phase-3-domperidone-in-treating-patients-with-gastrointestinal-disorders-100185996","NCT01696734","Domperidone in Treating Patients With Gastrointestinal Disorders","Treatment Protocol for the Compassionate Use of Domperidone","Inclusion Criteria:\n\n* Patients with GI disorders who have failed standard therapy\n* Symptoms or manifestations of: a) gastroparesis; b) refractory gastroesophageal reflux disease (GERD) including persistent esophagitis, refractory heartburn, reflux-related laryngitis, and respiratory symptoms; or c) severe dyspepsia\n* Completion of a comprehensive evaluation, including clinical history and physical examination, to eliminate other causes of their symptoms\n* Patient has signed the informed consent document agreeing to the use of the study drug, domperidone\n* White blood cell (WBC) with differential greater than 3,000\u002Fml\n* Alkaline phosphatase less than 1.5 x upper limit of normal\n* Alanine aminotransferase (ALT) less than 2 x upper limit of normal\n* Aspartate aminotransferase (AST) less than 2 x upper limit of normal\n* Bilirubin less than or equal to 2 x upper limit of normal\n* Blood urea nitrogen (BUN) less than 2 x upper limit of normal\n* Creatinine less than 1.5 x upper limit of normal\n* Stable hemoglobin greater than or equal to 8.0 g\u002Fdl\n* Potassium between range of 3.0 to 5.5\n* Magnesium level between 1.6-2.6 mg\n\nExclusion Criteria:\n\n* Patients with the following cardiac diagnoses: ventricular tachycardia or fibrillation; Torsade des Pointes; clinically significant bradycardia; sinus node dysfunction; heart block; prolonged QTc interval (QTc \\> 450 milliseconds for males, QTc \\> 470 milliseconds for females); prior specific cardiovascular conditions of clinically significant valvular heart disease requiring medication, ischemic, or pulmonary heart disease; cardiomyopathy; history of heart failure\n* Patients who are receiving antiarrhythmic medications with action on repolarization times (with prolongation of the QTc interval such as amiodarone, disopyramide, dofetilide, flecainide, ibutilide, quinidine, sotalol, dronedarone etc.)\n* Patients who are receiving monoamine oxidase (MAO) inhibitors\n* Patients with a history of or active liver failure\n* Clinically significant electrolyte disorders including sodium \\\u003C 130 or \\> 145 and\u002For potassium \\\u003C 3.0 or \\> 5.5 and\u002For magnesium \\\u003C 1.6 or \\> 2.6\n* GI hemorrhage or obstruction experienced within the previous 6 weeks\n* Presence of a prolactinoma (prolactin-releasing pituitary tumor)\n* Pregnant or breast-feeding female (women of childbearing potential \\[WOCBP\\], defined as not post-menopausal for 12 months or without previous surgical sterilization, must have a negative urine pregnancy test within 30 days of the first administration of domperidone and must either commit to continued abstinence from heterosexual intercourse or use an effective method of birth control during the course of the study)\n* Known allergy to domperidone","16 Years",{"count":58,"type":21},200,[60],"PHASE3","This phase III trial studies how well domperidone works in treating patients with gastrointestinal disorders. Domperidone may help control chronic gastrointestinal disorders and their symptoms, such as pain, bloating, and nausea and vomiting, by stimulating contraction of the stomach to increase its ability to empty itself of food.",[63,64,65,35,66,29,67],"Digestive System Disorder","Dyspepsia","Esophagitis","Gastroparesis","Nausea and Vomiting","RECRUITING","2026-04-10",{"date":71,"type":40},"2026-04-13",{"date":73,"type":40},"2012-10-23",{"date":75,"type":21},"2027-10-31",{"name":77,"class":47},"M.D. Anderson Cancer Center",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":78},"100514259","a-study-of-breath-testing-for-small-intestinal-bacterial-overgrowth-100514259","NCT05976165","A Study of Breath Testing for Small Intestinal Bacterial Overgrowth","Breath Testing for Small Intestinal Bacterial Overgrowth in Patients Treated With Proton Pump Inhibitors","Inclusion criteria:\n\n* Predominant symptoms of gastroesophageal reflux disease including heartburn, regurgitation\n* Subjects must be able to give appropriate informed consent\n\nExclusion criteria:\n\n* Prior diagnosis of SIBO\n* Use of PPIs or H2R-anatagonstists in the prior 3 months\n* Major concomitant illness (renal, hepatic, rheumatologic or cardiovascular disease, or malignancy)\n* Antibiotic therapy within one month\n* Prior gastrointestinal surgery including esophageal, gastric, and small or large bowel surgery\n* Previously diagnosed irritable bowel syndrome or inflammatory bowel disease\n* Individuals who are pregnant or breast feeding\n* Patients with plans to become pregnant\n* Inability to take PPIs, including allergy\u002Fsensitivity",{"count":87,"type":21},50,[24],"Researchers hope to determine how often small intestinal bacterial overgrowth occurs after taking proton pump inhibitors.",[31,91,29],"Regurgitation",[93],"Proton pump inhibitor","2026-02-10",{"date":96,"type":40},"2026-02-12",{"date":98,"type":40},"2023-11-17",{"date":100,"type":21},"2027-01-31",{"name":102,"class":47},"Mayo Clinic",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":115,"studyType":116,"phases":4,"briefSummary":117,"conditions":118,"keywords":122,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":78},"100566835","a-study-of-the-safety-of-vonoprazan-exposure-in-pregnant-women-and-their-offspring-100566835","NCT06660342","A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring","Vonoprazan Pregnancy Registry: An Observational Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring","Inclusion Criteria:\n\n* Women 15 to 50 years of age.\n* Currently or recently pregnant.\n* Consent to participate.\n* Authorization for her health care provider(s) (HCP\\[s\\]) to provide data to the registry.\n* Exposed cohort: Exposure to at least one dose of vonoprazan during pregnancy.\n* Unexposed cohort: Unexposed to vonoprazan and diagnosis of any condition for which vonoprazan may be prescribed.\n\nExclusion Criteria:\n\n* Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).\n* Exposure to known tetratogens and\u002For investigational medications during pregnancy.\n* Lost to follow-up.","FEMALE","15 Years","50 Years",{"count":114,"type":21},728,"12 Months","OBSERVATIONAL","The main objective of the study is to compare the maternal, fetal, and infant outcomes of pregnant women who are exposed to vonoprazan during pregnancy with outcomes of an internal comparison cohort of pregnant women who are unexposed to vonoprazan during pregnancy but who may be exposed to other products for the treatment of conditions for which vonoprazan may be prescribed.",[119,29,120,121],"Erosive Esophagitis","Symptomatic Non-erosive Gastroesophageal Reflux Disease","Helicobacter Pylori Infection",[119,29,120,121,123,124,125],"Pregnant Women","Fetal","Infant","2025-05-21",{"date":128,"type":40},"2025-05-22",{"date":130,"type":40},"2025-05-15",{"date":132,"type":21},"2034-09",{"name":134,"class":135},"Phathom Pharmaceuticals, Inc.","INDUSTRY",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":143,"sex":17,"minAge":18,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":48},"100523672","comparative-pharmacodynamics-and-pharmacodynamics-equivalence-of-antareit-800-mg10-ml-oral-suspension-and-riopan-800-mg-chewable-tablets-in-healthy-volunteers-100523672","NCT06098742","Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 mg\u002F10 ml Oral Suspension and Riopan 800 mg Chewable Tablets in Healthy Volunteers","An Open-label, Randomized, Crossover Study to Investigate the Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 mg\u002F10 ml Oral Suspension and Riopan 800 mg Chewable Tablets in Healthy Volunteers.","Inclusion Criteria:\n\n1. Voluntary and handwritten informed consent form signed by a healthy volunteer to participate in the study prior to any of the study procedures;\n2. Healthy male and female caucasian volunteers aged 18 to 45 years (inclusive);\n3. Verified diagnosis \"healthy\" (without abnormal findings in the protocol-defined clinical, laboratory, and instrumental test data);\n4. pH according to hourly pH-metry in the screening period, carried out at least 3 hours after the last meal, is completely in the range from 1 to 3 inclusive throughout the entire astronomical hour of measurement;\n5. Blood pressure (BP) levels: 100 to 139 mm Hg, inclusive (systolic, SBP), 60 to 89 mm Hg, inclusive (diastolic, DBP);\n6. Heart rate (HR) of 60 to 90 bpm, inclusive;\n7. Body mass index (BMI) of 18.5 kg\u002Fm2 ≤ BMI ≤ 30 kg\u002Fm2, where the body weight range is ≥ 55 kg for men and ≥ 45 kg for women;\n8. Non-smoking healthy volunteers (who have never smoked or gave up smoking more than 6 months prior to the Screening);\n9. Consent to use adequate methods of contraception throughout the study and for 30 days after completion; for women of preserved reproductive potential, a negative urine pregnancy test result;\n10. The volunteers must have adequate behavior and coherent speech.\n\nExclusion Criteria:\n\n1. A history of allergy;\n2. History of drug intolerance to the active and\u002For excipients included in the study drugs;\n3. History of drug intolerance of or hypersensitivity\u002Fallergic reactions to lidocaine, xylocaine or other topical anesthetics which will be used at the trial site for anesthesia during esophagogastroduodenoscopy (EGD) and insertion of the probe for the pH measurements;\n4. Chronic diseases of the circulatory, lymphatic, respiratory, nervous, endocrine, gastrointestinal, musculoskeletal, integumentary, immune, urogenital, and hematopoietic systems;\n5. Esophageal, gastric, and\u002For duodenal diseases based on EGC performed at screening and based on the medical history; a history of esophageal, gastric, and\u002For duodenal surgery;\n6. Diseases\u002Fconditions which, in the opinion of the investigator, may affect the pH measurement results;\n7. Acute infectious diseases less than 4 weeks prior to screening;\n8. Use of antacids (including sodium bicarbonate solution)\u002FH2 antagonists 24 h prior to the Screening Visit;\n9. Use of proton pump inhibitors 72 h prior to the Screening Visit;\n10. Use of (including use of a single dose) steroids and\u002For other ulcerogenic drug (e.g., nonsteriodal anti-inflammatory drugs \\[NSAID\\]) less than 4 weeks prior to the Screening Visit;\n11. Regular use of any medicinal products, including prescription only and OTC (Over-the-counter) drugs and dietary supplements within 2 weeks prior to the Screening Visit;\n12. Blood or plasma donation less than 3 months prior to the Screening Visit;\n13. Use of hormonal contraceptives (in women) less than 2 months prior to the Screening Visit;\n14. Pregnancy or breastfeeding; a positive pregnancy test for women of childbearing potential;\n15. Participation in another clinical trial less than 3 months prior to screening or simultaneously with this study;\n16. Use of more than 10 units of alcohol (1 unit of alcohol is equivalent to 330 ml of beer, 150 ml of wine or 40 ml of spirits) a week within a month prior to the enrollment in the study or history data of alcohol\u002Fdrug dependence or drug abuse.\n17. Positive antibody blood test for HIV-1 and HIV-2, Treponema pallidum antigen, hepatitis B surface antigen (HBsAg), or hepatitis C virus antigen;\n18. Positive urine test for narcotic substances or strong drugs;\n19. Positive test for alcohol vapor in exhaled breath or a positive alcohol saliva test;\n20. Deviated septum\u002Fnasal obstruction preventing the placement of the pH probe;\n21. Medical history of chronic constipation;\n22. Medical history of severe maxillofacial injuries;\n23. Expected admission to hospital during this study for any reason, except for hospitalization provided for by this protocol;\n24. Impossibility or failure to comply with the protocol, undergo protocol-defined procedures, or adhere to the diet or activity regime;\n25. Positive SARS-CoV-2 (severe acute respiratory syndrome related coronavirus) (COVID-19) rapid test;\n26. Other circumstances which in the opinion of the investigator prevent a volunteer from being included in the study or may result in premature drop-out from the study.\n\nWithdrawal criteria:\n\n1. The volunteer's refusal to further participate in the study;\n2. Failure of the volunteer to comply with the rules of participation in the study (skipping study procedures, independent use of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.);\n3. Taking prohibited therapy;\n4. Occurrence of causes\u002Foccurrence during the study of situations that threaten the safety of the volunteer, including severe AEs;\n5. Volunteers selected to participate in the study in violation of the inclusion\u002Fnon-inclusion criteria;\n6. Violation of the rules for conducting pH measurements or the occurrence of conditions that required early termination of pH measurements (vomiting, nosebleeds, etc.);\n7. Missing a dose of the study drug\u002Fcomparator drug during any period of the study for any reason;\n8. Positive urine test for narcotics and powerful drugs;\n9. Positive breath alcohol vapor test or alcohol in saliva;\n10. Positive pregnancy test in women;\n11. Positive test for COVID-19;\n12. The occurrence in the course of the study of other reasons that prevent the study according to the protocol.",true,"45 Years",{"count":87,"type":21},[24],"Comparative study of the pharmacodynamic parameters and pharmacodynamic equivalence (bioequivalence) of drug Antareit 800 mg\u002F10 ml oral suspension and drug Riopan 800 mg chewable tablets in healthy volunteers.",[29,149,150],"Acid-dependent Diseases of the Gastrointestinal Tract","Symptomatic Treatment of Gastric and Duodenal Ulcers","2024-07-19",{"date":153,"type":40},"2024-07-22",{"date":155,"type":40},"2024-04-25",{"date":157,"type":21},"2025-09-20",{"name":159,"class":135},"Valenta Pharm JSC"]