[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06241183":3,"trial-entities:NCT06241183":97,"trial-summary:NCT06241183":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":51,"secondary_outcomes":56,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":15,"eligibility_criteria":66,"std_ages":70,"locations":73,"central_contacts":90,"overall_officials":94,"references":95,"see_also_links":96},"NCT06241183","IRB2023-00188","Famotidine and Antacids for Treatment of Dyspepsia","Comparing Intravenous Famotidine and Oral Antacids in the Treatment of Dyspepsia in the Emergency Department","RECRUITING","2027-12-31","2026-06","2026-06-02","2023-11-09","Stony Brook University","OTHER",false,"The aim of this study is to compare intravenous famotidine, an H2 receptor antagonist, and Maalox\u002F Mylanta, an oral antacid, in treatment of dyspepsia in the emergency department. The goal of this study is to reduce patients' pain based on the verbal numerical pain scale. The anticipated outcome is for pain levels in both groups to decrease. It is expected that antacids will improve symptoms more quickly and to a greater degree within an hour of taking medication based on the results of similar studies.","This study will be conducted in the Emergency Department at Stony Brook University Hospital. Investigators intend to enroll approximately 80 patients who present to the emergency department with dyspepsia symptoms. The patients will be randomized to one of two groups: one group will receive 20 mg of intravenous famotidine and the other will receive 30 ml of oral Maalox\u002F Mylanta. The verbal numeric pain score (VNP) will be used to measure pain at 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after administration of the study drug. Pain severity assessments will be performed by an investigator blinded to study treatment. Data will also be collected regarding demographic, clinical information, patient satisfaction and the need for rescue medications in each of the two study groups at the end of the 60-minute study period. At the end of the study period, the patients may be treated with additional analgesia at the discretion of their ED provider.",[19,20,21],"Dyspepsia","GERD","Acid Reflux",[23,20,21,24,25,26,27,28],"dyspepsia","H2 receptor antagonist","antacid","Maalox","Mylanta","Famotidine","INTERVENTIONAL","TREATMENT",[32],"PHASE4",{"count":34,"type":35},80,"ESTIMATED",[37,44],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","Intravenous Famotidine","Patients in this group will receive 20mg IV Famotidine.",[39],[43],"H2 Receptor Antagonist",{"type":38,"name":45,"description":46,"armGroupLabels":47,"otherNames":49},"Oral Maalox\u002F Mylanta","Patients in this group will receive 30 ml Maalox\u002F Mylanta.",[48],"Oral Maalox",[50],"Antacid",[52],{"measure":53,"description":54,"timeFrame":55},"Verbal Numerical Pain Score","Patients will be asked to rate their pain on a scale of 0 to 10 with 0 indicating no pain and 10 indicating the worst pain imaginable every 15 minutes for 60 minutes.","at 1 hour",[57,60],{"measure":58,"description":59,"timeFrame":55},"Need for Rescue Medications","Investigators will assess frequency of need for rescue medications between groups.",{"measure":61,"description":62,"timeFrame":55},"Satisfaction with Assigned Medication","Investigators will gather data regarding patient satisfaction with their assigned treatment using a 5 item likert scale from very dissatisfied (1), dissatisfied (2) neither satisfied nor dissatisfied (3), satisfied (4) and very satisfied (5). The outcome will be measured as the percentages of patients choosing very satisfied or satisfied with their assigned medications.","ALL","18 Years",null,{"inclusion":67,"exclusion":68,"raw_text":69},[],[],"Inclusion Criteria:\n\n1. Subject Age ≥ 18 years of age\n2. Patient diagnosed with dyspepsia\n3. Present at the ED with upper abdominal pain score of at least 3\n\nExclusion Criteria:\n\n1. Hypersensitivity to an ingredient in Maalox\u002F Mylanta or Famotidine\n2. Moderate to Severe Renal Insufficiency (precaution)\n3. Kidney Failure\n4. Pregnant or Nursing\n5. Verbal pain score less than 3\n6. Inability to tolerate oral medications\n7. Bowel Obstruction\n8. Proton pump inhibitor within 2 hours of study treatment",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":75,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":87},"Stony Brook University Hospital","Stony Brook","New York","11794","United States",[81,84],{"name":82,"role":83},"Andrea Gowie","CONTACT",{"name":85,"role":86},"Adam Singer, MD","PRINCIPAL_INVESTIGATOR",{"lat":88,"lon":89},40.92565,-73.14094,[91],{"name":85,"role":83,"phone":92,"email":93},"6314447857","adam.singer@stonybrookmedicine.edu",[],[],[],{"nct_id":4,"conditions":98,"biomarkers":99},[19],[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an interventional study planning to enroll about 80 participants. You would be randomly assigned to receive either intravenous famotidine or oral Maalox\u002FMylanta.","completed","Famotidine and Antacids for Dyspepsia in the Emergency Department","This study is looking at two common treatments for dyspepsia (upset stomach or indigestion), GERD (acid reflux), and acid reflux in people who come to the emergency department. Researchers want to see if intravenous (IV) famotidine or oral Maalox\u002FMylanta is better at reducing pain. You might be able to join if you are at least 18 years old, have been diagnosed with dyspepsia, and have upper abdominal pain that is at least a 3 on a pain scale. The study aims to see which treatment reduces pain more effectively within one hour. The current recruitment status is unclear.","Your pain will be measured for 60 minutes after receiving the study medication.",98,"You would receive one of the study medications and have your pain measured at several time points over 60 minutes.","Not stated in the trial record.",[],"v2"]