{"id":"magnesium-hydroxide","rwe":[],"_fda":{"id":"09a7141e-5879-df3c-e063-6394a90a9962","set_id":"003a3c0d-7a48-e44d-e063-6394a90a3f4a","openfda":{"unii":["NBZ3QY004S"],"route":["ORAL"],"rxcui":["253017"],"spl_id":["09a7141e-5879-df3c-e063-6394a90a9962"],"brand_name":["MILK OF MAGNESIA"],"spl_set_id":["003a3c0d-7a48-e44d-e063-6394a90a3f4a"],"package_ndc":["70677-1072-1"],"product_ndc":["70677-1072"],"generic_name":["MAGNESIUM HYDROXIDE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["MAGNESIUM HYDROXIDE"],"manufacturer_name":["Strategic Sourcing Services LLC"],"application_number":["M007"],"is_original_packager":[true]},"purpose":["Purpose Saline laxative"],"version":"2","warnings":["Warnings Ask a doctor before use if you have kidney disease a magnesium-restricted diet stomach pain, nausea, or vomiting a sudden change in bowel habits that lasts over 14 days ​ Ask a doctor or pharmacist before use if you are presently taking a prescription drug. This product may interact with certain prescription drugs. Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition. you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"questions":["Questions or comments? Call 833-358-6431"],"effective_time":"20231108","active_ingredient":["Active ingredient (in each 15 mL) Magnesium hydroxide 1200 mg"],"inactive_ingredient":["Inactive ingredients carboxymethylcellulose sodium, citric acid, D & C red no. 28, flavor, glycerin, microcrystalline cellulose, purified water, sodium citrate, sodium hypochlorite, sucrose, xanthan gum"],"storage_and_handling":["Other information each 15 mL contains: magnesium 500 mg, sodium 6 mg store at room temperature tightly closed avoid freezing"],"indications_and_usage":["Uses relieves occasional constipation (irregularity) generally produces bowel movement in 1/2 to 6 hours"],"dosage_and_administration":["Directions shake well before use do not exceed the maximum recommended daily dose in a 24 hour period dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor drink a full glass (8 oz) of liquid with each dose for accurate dosing, only use the dosing cup provided mL = milliliter age dose adults and children 12 years and over 30 mL to 60 mL children 6 to 11 years 15 mL to 30 mL children under 6 years ask a doctor"],"spl_product_data_elements":["MILK OF MAGNESIA magnesium hydroxide ANHYDROUS CITRIC ACID D&C RED NO. 28 MICROCRYSTALLINE CELLULOSE GLYCERIN XANTHAN GUM SODIUM CITRATE WATER SODIUM HYPOCHLORITE MAGNESIUM HYDROXIDE MAGNESIUM CATION HYDROXIDE ION SUCROSE CARBOXYMETHYLCELLULOSE SODIUM"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"dosage_and_administration_table":["<table border=\"1\" width=\"100%\"><tbody><tr><td>age</td><td>dose</td></tr><tr><td>adults and children 12 years and over</td><td>30 mL to 60 mL</td></tr><tr><td>children 6 to 11 years</td><td>15 mL to 30 mL</td></tr><tr><td>children under 6 years</td><td>ask a doctor</td></tr></tbody></table>"],"package_label_principal_display_panel":["package Label 1"]},"tags":[],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"CHRONIC KIDNEY DISEASE","source":"FDA FAERS","actionTaken":"2973 reports"},{"date":"","signal":"ACUTE KIDNEY INJURY","source":"FDA FAERS","actionTaken":"1830 reports"},{"date":"","signal":"CONSTIPATION","source":"FDA FAERS","actionTaken":"1681 reports"},{"date":"","signal":"RENAL FAILURE","source":"FDA FAERS","actionTaken":"1621 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"1306 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1302 reports"},{"date":"","signal":"FALL","source":"FDA FAERS","actionTaken":"1245 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"1236 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"1069 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"913 reports"}],"drugInteractions":[],"commonSideEffects":[],"contraindications":["Aluminum intoxication","Appendicitis","Chronic diarrhea","Dehydration","Diarrhea","Disease of liver","Fecal impaction","Gastrointestinal obstruction","Hemorrhoids","Hypercalcemia","Hypermagnesemia","Hyperparathyroidism","Hypophosphatemia","Impaired renal function disorder","Kidney disease","Kidney stone","Malignant tumor of stomach","Osteolysis","Sarcoidosis"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"approved","trials":["NCT07041814","NCT00258245","NCT00944307","NCT01784302","NCT04269356","NCT00421590","NCT02382640","NCT00247715","NCT04640168","NCT04890873","NCT02065401","NCT01982201","NCT03065816","NCT06146712","NCT01336530","NCT01370538","NCT01370525","NCT06374823","NCT00083382","NCT02245269","NCT01930045","NCT05386810","NCT06503978","NCT00446316","NCT02516202","NCT04802785","NCT00906971","NCT03106584","NCT06819033","NCT01622673","NCT02542319","NCT03738904","NCT02216877","NCT03490396","NCT01773096","NCT01118923","NCT05109390","NCT07235878","NCT03069963","NCT04382157","NCT04401579","NCT01691742","NCT01037452","NCT00679302","NCT01156129","NCT01118936","NCT06335797","NCT02606994","NCT07310927","NCT04864561"],"aliases":["Milk of Magnesia","Phillips\\",", "],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=magnesium hydroxide","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:28:41.155039+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:28:46.489044+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:28:40.242520+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=magnesium hydroxide","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:28:46.842716+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:28:38.169258+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:28:38.169279+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:28:48.371392+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200718/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:28:47.583076+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M007","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:28:38.169285+00:00"}},"allNames":"milk of magnesia","offLabel":[],"timeline":[],"aiSummary":"Magnesium hydroxide (Milk of Magnesia) is one of the oldest OTC medications, in use since 1880. Serves as both an antacid and osmotic laxative. Available generically.","brandName":"Milk of Magnesia","companyId":"unknown","ecosystem":[],"mechanism":{"target":"Gastric acid (direct neutralization) + osmotic effect in intestine","novelty":"","modality":"Inorganic salt","drugClass":"Osmotic laxative, Antacid","explanation":"","oneSentence":"","technicalDetail":""},"commercial":null,"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:28:49.915672+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"companyName":"Generic (multiple manufacturers)","competitors":[],"genericName":"magnesium hydroxide","indications":{"approved":[{"name":"Constipation","diseaseId":"constipation","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Gastric Hypersecretory Conditions","diseaseId":"gastric-hypersecretory-conditions","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Gastroesophageal reflux disease","diseaseId":"gastroesophageal-reflux-disease","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Heartburn","diseaseId":"heartburn","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Heartburn Prevention","diseaseId":"heartburn-prevention","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Hiatal Hernia with Reflux Esophagitis","diseaseId":"hiatal-hernia-with-reflux-esophagitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Incomplete passage of stool","diseaseId":"incomplete-passage-of-stool","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Indigestion","diseaseId":"indigestion","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Peptic ulcer","diseaseId":"peptic-ulcer","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT07041814","phase":"Phase 2","title":"Bayesian Pragmatic Trial for Pubertal Induction in Turner Syndrome: TRansformation Initiative For Efficient Clinical TriAl Design Advancement in RarE Diseases (TRIFECTA-DARED Framework)","status":"NOT_YET_RECRUITING","sponsor":"Universiti Kebangsaan Malaysia Medical Centre","isPivotal":false,"enrollment":24,"indication":"Turner Syndrome","completionDate":"2029-10-31"},{"nctId":"NCT00258245","phase":"Phase 1","title":"A Phase I Study of Arsenic Trioxide and Ascorbic Acid (ATO/AA) in Combination With Low Dose Velcade-Thalidomide-Dexamethasone (VTD) in Relapsed/Refractory Multiple Myeloma (MM)","status":"COMPLETED","sponsor":"Barbara Ann Karmanos Cancer Institute","isPivotal":false,"enrollment":5,"indication":"Multiple Myeloma and Plasma Cell Neoplasm","completionDate":"2008-04"},{"nctId":"NCT00944307","phase":"Phase 1","title":"Effect of Antacids on the Pharmacokinetics of Raltegravir in Healthy Volunteers","status":"COMPLETED","sponsor":"University of Colorado, Denver","isPivotal":false,"enrollment":17,"indication":"HIV Infections","completionDate":"2009-12"},{"nctId":"NCT01784302","phase":"Phase 1","title":"A 3 Arm, 5 Phase Study to Determine the Effect of Divalent and Monovalent Metal Containing Antacids and Multivitamins on the Pharmacokinetics of Raltegravir in Healthy Volunteers","status":"COMPLETED","sponsor":"Helen Reynolds","isPivotal":false,"enrollment":15,"indication":"HIV","completionDate":"2016-02"},{"nctId":"NCT04269356","phase":"Phase 1","title":"Pharmacokinetics and Metabolism of a Single Dose of [14C] BMS-986256 in Healthy Male Participants","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","isPivotal":false,"enrollment":8,"indication":"Healthy Participants","completionDate":"2021-03-30"},{"nctId":"NCT00421590","phase":"Phase 2","title":"A Randomized, Partially Blind, Placebo Controlled, Crossover, Single Oral Dose Study to Assess the Effect of Concomitant Antacid (Calcium Carbonate / Magnesium Hydroxide) on the Pharmacokinetics and P","status":"COMPLETED","sponsor":"Novartis","isPivotal":false,"enrollment":38,"indication":"Health Postmenopausal Women","completionDate":""},{"nctId":"NCT02382640","phase":"Phase 1","title":"A Phase 1, Open-Label, Single Center, Single-Dose, Randomized, 4-Way Crossover Study to Assess the Effect of an Antacid on the Bioavailability of Febuxostat After Oral Administration of a 80 mg Febuxo","status":"COMPLETED","sponsor":"Takeda","isPivotal":false,"enrollment":36,"indication":"Healthy Volunteers","completionDate":"2015-05"},{"nctId":"NCT00247715","phase":"NA","title":"Comparison of an Antacid/H2-Receptor Antagonist/Proton Pump Inhibitor Versus a Proton Pump Inhibitor/H2-Receptor Antagonist/Antacid Treatment Strategy for Patients With New Onset Dyspepsia in General ","status":"COMPLETED","sponsor":"Radboud University Medical Center","isPivotal":false,"enrollment":664,"indication":"Dyspepsia, Gastrointestinal Diseases","completionDate":"2007-01"},{"nctId":"NCT04640168","phase":"Phase 3","title":"A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults (ACTT-4)","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","isPivotal":true,"enrollment":1010,"indication":"COVID-19","completionDate":"2021-06-18"},{"nctId":"NCT04890873","phase":"Phase 1","title":"ERX1000 - A Phase I, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Male and Female Subjects With Obesity","status":"COMPLETED","sponsor":"ERX Pharmaceuticals","isPivotal":false,"enrollment":48,"indication":"Obesity","completionDate":"2023-07-03"},{"nctId":"NCT02065401","phase":"Phase 1","title":"A Phase 1, Open-label, Randomized, 3-Period, Relative Bioavailability Study Comparing the Pharmacokinetics of Granule and Tablet Formulations of Deferitazole (Disodium Salt) and a Capsule Formulation ","status":"WITHDRAWN","sponsor":"Shire","isPivotal":false,"enrollment":0,"indication":"Healthy","completionDate":"2014-03-19"},{"nctId":"NCT01982201","phase":"Phase 1","title":"A Phase 1, Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interaction Between Lesinurad and Calcium Carbonate and Aluminum/Magnesium ","status":"COMPLETED","sponsor":"Ardea Biosciences, Inc.","isPivotal":false,"enrollment":24,"indication":"Healthy","completionDate":"2014-03"},{"nctId":"NCT03065816","phase":"Phase 1","title":"A Randomized, Open-label, 2-Treatment Crossover Study to Compare by Scintigraphy, the Antireflux Activity of the To-be-Registered Product (250 mg Sodium Alginate/187.5 mg Calcium Carbonate/106.5 mg So","status":"COMPLETED","sponsor":"Sanofi","isPivotal":false,"enrollment":34,"indication":"Gastroesophageal Reflux Disease","completionDate":"2017-05-02"},{"nctId":"NCT06146712","phase":"NA","title":"A Single-Group Study to Examine the Efficacy of a Melatonin Lotion With Magnesium to Improve Sleep Quality and Quantity","status":"COMPLETED","sponsor":"Asutra","isPivotal":false,"enrollment":35,"indication":"Sleep","completionDate":"2023-10-02"},{"nctId":"NCT01336530","phase":"Phase 3","title":"Clinical Trial to Assess the Efficacy of Fixed Combination Product Tepilta® in the Treatment of Radiation-induced Oesophagitis Compared to Its Active Ingredients Oxetacaine and Antacids, and to Placeb","status":"TERMINATED","sponsor":"MEDA Pharma GmbH & Co. KG","isPivotal":true,"enrollment":40,"indication":"Radiation-induced Oesophagitis","completionDate":"2017-01"},{"nctId":"NCT01370538","phase":"Phase 3","title":"A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Esomeprazole 20 mg Once Daily in Subjects With Frequent Heartburn","status":"COMPLETED","sponsor":"AstraZeneca","isPivotal":true,"enrollment":341,"indication":"Heartburn","completionDate":"2011-10"},{"nctId":"NCT01370525","phase":"Phase 3","title":"A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Esomeprazole 20 mg Once Daily in Subjects With Frequent Heartburn","status":"COMPLETED","sponsor":"AstraZeneca","isPivotal":true,"enrollment":340,"indication":"Heartburn","completionDate":"2011-10"},{"nctId":"NCT06374823","phase":"Phase 4","title":"The Impact of Multiple Electrolytes Injection (II) and Normal Saline on Hyperchloremia in Severe Hemorrhagic Stroke Patients: A Prospective, Multicenter, Open-label, Randomized Controlled Study","status":"NOT_YET_RECRUITING","sponsor":"Capital Medical University","isPivotal":false,"enrollment":342,"indication":"Critical Care, Hyperchloremia","completionDate":"2026-12"},{"nctId":"NCT00083382","phase":"Phase 2","title":"UARK 98-036, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide in Patients With Smoldering/Indolent Myeloma","status":"COMPLETED","sponsor":"University of Arkansas","isPivotal":false,"enrollment":83,"indication":"Multiple Myeloma","completionDate":"2014-05"},{"nctId":"NCT02245269","phase":"Phase 1","title":"A Two-way Pharmacokinetic Interaction Study of Single-Dose Atorvastatin (LIPITOR®) With Tipranavir/Ritonavir (500mg/200mg) at Steady-State and the Effect of Antacid (MAALOX®) on the Pharmacokinetics o","status":"COMPLETED","sponsor":"Boehringer Ingelheim","isPivotal":false,"enrollment":23,"indication":"Healthy","completionDate":""},{"nctId":"NCT01930045","phase":"Phase 1","title":"A Study to Evaluate the Effect of Staggered Dosing of a Magnesium/Aluminum Antacid on Raltegravir Pharmacokinetics in HIV-Infected Subjects on a Raltegravir-Containing Regimen","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":false,"enrollment":18,"indication":"HIV Infections","completionDate":"2013-12-10"},{"nctId":"NCT05386810","phase":"Phase 3","title":"A Clinical Trial With an Open-label Phase to Evaluate the Safety of Five-dose Sabin Inactivated Poliovirus Vaccine (Vero Cell)（ msIPV） in Adults, Children and Infants, and a Blinded,Randomized and Con","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","isPivotal":true,"enrollment":1572,"indication":"Poliomyelitis","completionDate":"2023-07-20"},{"nctId":"NCT06503978","phase":"Phase 2","title":"Dosing Study of Microbiota Transplant Therapy for Children With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders","status":"ACTIVE_NOT_RECRUITING","sponsor":"Gut-Brain-Axis Therapeutics Inc.","isPivotal":false,"enrollment":60,"indication":"Autism Spectrum Disorder, Gastro-Intestinal Disorder","completionDate":"2026-08-17"},{"nctId":"NCT00446316","phase":"Phase 1","title":"Effect of Antacids (Mg-Al-based) on Imatinib Mesylate (Gleevec®) Pharmacokinetics in Healthy Volunteers (CSTI571BUS257)","status":"COMPLETED","sponsor":"University of Pittsburgh","isPivotal":false,"enrollment":12,"indication":"Healthy","completionDate":"2008-10"},{"nctId":"NCT02516202","phase":"Phase 3","title":"The Vaginal Health Trial - Effects of Vaginal Estradiol Tablet and Moisturizing Gel on Postmenopausal Vaginal Symptoms","status":"COMPLETED","sponsor":"Fred Hutchinson Cancer Center","isPivotal":true,"enrollment":302,"indication":"Atrophy of Vagina, Menopause","completionDate":"2017-07"},{"nctId":"NCT04802785","phase":"Phase 2","title":"The Impact of Air Travel on Passenger Cognitive Functions","status":"UNKNOWN","sponsor":"Dinara Zhumanbayeva","isPivotal":true,"enrollment":50,"indication":"Air Travel","completionDate":"2022-05"},{"nctId":"NCT00906971","phase":"NA","title":"Physiotherapeutic Intervention in Children With Chronic Functional Constipation","status":"COMPLETED","sponsor":"Universidade Federal de Pernambuco","isPivotal":false,"enrollment":72,"indication":"Chronic Constipation","completionDate":"2010-04"},{"nctId":"NCT03106584","phase":"NA","title":"Investigating the Potential for Marigot's Nutrition Supplement to Improve Symptoms and Physical Function in Those With Mild to Moderate Knee Osteoarthritis (KOA) Versus the Current Market Leader (Gluc","status":"UNKNOWN","sponsor":"University College Dublin","isPivotal":false,"enrollment":30,"indication":"Knee Osteoarthritis","completionDate":"2017-10-01"},{"nctId":"NCT06819033","phase":"Phase 4","title":"Effects of Photobiomodulation on Pain After Presentation of Aphthous Ulcers in Pediatric Dental Patients","status":"RECRUITING","sponsor":"The University of Texas Health Science Center, Houston","isPivotal":false,"enrollment":30,"indication":"Aphthous Ulcer","completionDate":"2026-02-28"},{"nctId":"NCT01622673","phase":"Phase 1","title":"A Study to Evaluate the Effect of Metal Cation-Containing Antacids on Raltegravir Pharmacokinetics in HIV-Infected Subjects on a Stable Raltegravir-Containing Regimen","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":false,"enrollment":27,"indication":"HIV Infections","completionDate":"2012-10"},{"nctId":"NCT02542319","phase":"Phase 2","title":"The Effect of Oral Magnesium Supplementation on Vascular Calcification in Chronic Kidney Disease - A Randomized Clinical Trial","status":"COMPLETED","sponsor":"Nordsjaellands Hospital","isPivotal":false,"enrollment":148,"indication":"Chronic Kidney Disease, Vascular Calcification","completionDate":"2021-07"},{"nctId":"NCT03738904","phase":"Phase 4","title":"Prospective Randomized Controlled Trial of an Enhanced Recovery Protocol for Anorectal Surgery","status":"COMPLETED","sponsor":"Cedars-Sinai Medical Center","isPivotal":false,"enrollment":111,"indication":"Anorectal Disorder","completionDate":"2022-08-18"},{"nctId":"NCT02216877","phase":"Phase 1","title":"Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease - A Dose-Finding Trial","status":"COMPLETED","sponsor":"Zealand University Hospital","isPivotal":false,"enrollment":36,"indication":"Chronic Kidney Disease, Hypomagnesemia","completionDate":"2015-04"},{"nctId":"NCT03490396","phase":"Phase 4","title":"An Adaptive Design, Single-Blind, Randomized, Controlled Study Investigating Polyvinylpyrrolidone (PVP) and Sodium Hyaluronate-Containing Oral Gel (Gelclair®) in Comparison to Viscous Lidocaine, Diphe","status":"TERMINATED","sponsor":"Midatech Pharma US Inc.","isPivotal":false,"enrollment":28,"indication":"Oral Mucositis","completionDate":"2019-11-15"},{"nctId":"NCT01773096","phase":"Phase 4","title":"The Use of Methylnaltrexone to Reduce Post-operative Opioid-induced Constipation in the Pediatric Spinal Fusion Patient","status":"COMPLETED","sponsor":"Shriners Hospitals for Children","isPivotal":false,"enrollment":60,"indication":"Constipation","completionDate":"2015-05"},{"nctId":"NCT01118923","phase":"NA","title":"Metacholine-provocation of Mablet-treated Asthmatics","status":"COMPLETED","sponsor":"University of Aarhus","isPivotal":false,"enrollment":12,"indication":"Asthma","completionDate":"2013-03"},{"nctId":"NCT05109390","phase":"Phase 1","title":"A Three-Part Phase 1 Study to Evaluate the Potential Drug Interaction Between ACH-0144471 and Cyclosporine, Tacrolimus, Antacids, and Omeprazole in Healthy Adult Subjects","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","isPivotal":false,"enrollment":72,"indication":"Healthy","completionDate":"2018-10-17"},{"nctId":"NCT07235878","phase":"NA","title":"Effects of 12-week Magnesium Supplementation on Peri-menopause Symptoms, Cognition, Sleep and Psychological Wellbeing - a Randomised, Placebo-controlled Trial","status":"NOT_YET_RECRUITING","sponsor":"Northumbria University","isPivotal":false,"enrollment":58,"indication":"Perimenopause, Perimenopausal Women","completionDate":"2026-08-01"},{"nctId":"NCT03069963","phase":"Phase 1","title":"A Randomized, Open Label, 2-Treatment Crossover Study to Compare by pH Metry, the Antacid Activity of the To-be-registered Product (250 mg Sodium Alginate/187.5 mg Calcium Carbonate/106.5 mg Sodium Hy","status":"COMPLETED","sponsor":"Sanofi","isPivotal":false,"enrollment":24,"indication":"Gastroesophageal Reflux Disease","completionDate":"2017-04-23"},{"nctId":"NCT04382157","phase":"Phase 1","title":"Magnesium Replacement and Hyperglycemia After Kidney Transplantation","status":"UNKNOWN","sponsor":"Oslo University Hospital","isPivotal":false,"enrollment":40,"indication":"Hypomagnesemia, Kidney Transplantation","completionDate":"2022-08-31"},{"nctId":"NCT04401579","phase":"Phase 3","title":"A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults (ACTT-2)","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","isPivotal":true,"enrollment":1033,"indication":"COVID-19","completionDate":"2020-07-31"},{"nctId":"NCT01691742","phase":"NA","title":"Double-Blind Randomized Controlled Trial of MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery in Women Receiving Routine Docusate Sodium","status":"COMPLETED","sponsor":"Duke University","isPivotal":false,"enrollment":131,"indication":"Post Procedural Constipation","completionDate":"2015-04"},{"nctId":"NCT01037452","phase":"Phase 2","title":"A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Group Proof-of-Concept Trial to Assess Relief of Meal Induced Heartburn by a Combination of Lansoprazole 15 mg and Antacid Versus Lan","status":"COMPLETED","sponsor":"Novartis","isPivotal":false,"enrollment":120,"indication":"Heartburn","completionDate":""},{"nctId":"NCT00679302","phase":"Phase 4","title":"A Double Blinded Randomized Controlled Trial for the Management of Pediatric Community Acquired Skin Abscesses - To Treat or Not to Treat With Antibiotics","status":"COMPLETED","sponsor":"St. Louis University","isPivotal":false,"enrollment":161,"indication":"Skin Diseases, Infectious","completionDate":"2008-05"},{"nctId":"NCT01156129","phase":"Phase 1","title":"Interventions to Decrease the Impact of Post-Operative Ileus After Liver Transplant or Resection Surgery","status":"COMPLETED","sponsor":"University of Nebraska","isPivotal":false,"enrollment":111,"indication":"Ileus","completionDate":"2012-12-01"},{"nctId":"NCT01118936","phase":"NA","title":"Daily Mablet-treatment of Patients With COPD","status":"COMPLETED","sponsor":"University of Aarhus","isPivotal":false,"enrollment":11,"indication":"COPD","completionDate":"2013-03"},{"nctId":"NCT06335797","phase":"NA","title":"Optimization of Postoperative Bowel Habits Following Pelvic Reconstructive Surgery: a Randomized Controlled Trial","status":"RECRUITING","sponsor":"Wake Forest University Health Sciences","isPivotal":false,"enrollment":88,"indication":"Constipation","completionDate":"2027-05"},{"nctId":"NCT02606994","phase":"Phase 2","title":"Comparison of the Healing of Chemotherapy-Induced Oral Mucositis Using Oral Defense Toothpaste Versus Crest Toothpaste and Magic Mouth Rinse","status":"TERMINATED","sponsor":"Oral Defense, LLC","isPivotal":false,"enrollment":1,"indication":"Mucositis, Neoplasms","completionDate":"2019-02-04"},{"nctId":"NCT07310927","phase":"Phase 2","title":"Alginate vs Sucralfate for GERD Symptomatic Relief in Combination With PPIS","status":"RECRUITING","sponsor":"CMH Lahore Medical College and Institute of Dentistry","isPivotal":true,"enrollment":140,"indication":"GERD","completionDate":"2026-04"},{"nctId":"NCT04864561","phase":"Phase 3","title":"A Randomized, Observer-Blind, Controlled, Superiority Study To Compare The Immunogenicity Against COVID-19, Of VLA2001 Vaccine To AZD1222 Vaccine, In Adults Including a Randomized, Observer-blind, Pla","status":"COMPLETED","sponsor":"Valneva Austria GmbH","isPivotal":true,"enrollment":4034,"indication":"SARS-CoV-2 Virus Infection","completionDate":"2023-03-13"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"Oral","frequency":"As needed","formulation":"Oral suspension, Chewable tablet"},"crossReferences":{"chemblId":"CHEMBL1200718"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":877,"therapeuticAreas":["Cardiovascular"],"biosimilarFilings":[],"firstApprovalDate":"1880-01-01","companionDiagnostics":[],"firstApprovalCountry":"United States","genericManufacturerList":[],"modality":"Inorganic salt","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2004-10-27T00:00:00.000Z","mah":"KENVUE BRANDS","brand_name_local":null,"application_number":"NDA020958"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2008-02-06T00:00:00.000Z","mah":"PERRIGO R AND D","brand_name_local":null,"application_number":"ANDA077355"},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:28:49.915672+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}