Page last updated: 2024-12-05

magnesium citrate

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Occurs in Manufacturing Related Drugs Related Conditions Protein Interactions Research Growth

Description

magnesium citrate : A magnesium salt composed of magnesium and dibasic citrate ions in a 1:1 ratio. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

trimagnesium dicitrate : A magnesium salt composed of magnesium and citrate ions in a 3:2 ratio. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID6099959
CHEMBL ID3989480
CHEBI ID131391
MeSH IDM0286260

Synonyms (87)

Synonym
citric acid, magnesium salt (2:3)
magnesium citrate
nsc-83517
3344-18-1
tectlol (tn)
magnesium citrate (jan/usp)
D03265
trimagnesium dicitrate
einecs 222-093-9
magnesium citrate (3:2)
magnesium citrate (van)
nsc 83517
trimagnesiumdicitrat
1,2,3-propanetricarboxylic acid, hydroxy-, magnesium salt (2:3)
1,2,3-propanetricarboxylic acid, 2-hydroxy-, magnesium salt (2:3)
tectlol
CHEBI:131391 ,
magnesium 2-hydroxypropane-1,2,3-tricarboxylate (3/2)
magnesium dicitrate
trimagnesium citrate
magnesium citrate [usp]
unii-rho26o1t9v
ec 222-093-9
rho26o1t9v ,
FT-0628080
FT-0628081
magnesium citrate tribasic anhydrous
magnesium citrate [usp-rs]
magnesium citrate [usp monograph]
magnesium citrate [jan]
magnesium citrate [mart.]
magnesium citrate [ep monograph]
magnesium citrate [inci]
magnesium citrate [who-dd]
magnesium citrate [vandf]
magnesium citrate [mi]
citramag
PLSARIKBYIPYPF-UHFFFAOYSA-H
tri magnesium citrate
T2966
trimagnesiumdicitrate
magnesiumcitrate
AKOS028109620
DB11110
Q4177438
trimagnesium;2-hydroxypropane-1,2,3-tricarboxylate
CHEMBL3989480
DTXSID601015151 ,
D78504
HY-W105835
CS-0158477
dtxcid801473484
citrate of magnesium
magnesium citratelemon readyincase
bet-r-prep magnesium citrate oral
be health magnesium citrate oral solution-lemon
leadersaline laxative-grape
be health magnesium citrate oral solution-cherry
cvs magnesium citrate oral solution-grape
leadersaline laxative-lemon
freskaro magnesium citrate oral solution-grape
magnesium citrate (usp monograph)
citroma
mg citrate
gadavyt
citrate of magnesia
truemedsaline laxative-cherry
magesium citrate
cvs magnesium citrate oral solution-lemon
leadersaline laxative-cherry
freskaro magnesium citrate oral solution-cherry
cvs magnesium citrate oral solution-cherry
max lax
max laxlemon
truemedsaline laxative-grape
magnesium citratesaline laxative
magnesium citrate (usp-rs)
truemed
magnesium citrate (mart.)
be health magnesium citrate oral solution-grape
majorsaline laxative-lemon
max laxcherry
freskaro magnesium citrate oral solution-lemon
citromag
truemedsaline laxative-lemon
magnesium citrate (ep monograph)
pen prep

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" All these preparations give adequate cleansing results and have similar profiles in terms of the frequency and type of mild to moderate adverse effects."( The safety of osmotically acting cathartics in colonic cleansing.
Hendel, J; Nielsen, OH; Nyberg, C, 2010
)
0.36
" This observational study with 737 patients evaluated efficacy of bowel preparation, potential side or adverse effects and patient acceptance of this medicinal product when used by resident physicians in Germany."( Observational multicentric study to evaluate efficacy, adverse effects and acceptance of bowel cleansing prior to colonoscopy with sodium picosulfate / magnesium citrate formulation CitraFleet®.
Deissler, H; Janisch, HD; Koppold, B; Riemann, JF, 2016
)
0.43
"Patient characteristics, tolerance of full bowel preparation, pre- and post-bowel preparation electrolyte values, adverse events, and adequacy of bowel cleansing were abstracted."( A safe and effective multi-day colonoscopy bowel preparation for individuals with spinal cord injuries.
Burns, SP; Dominitz, JA; Song, SH; Svircev, JN; Teng, BJ, 2018
)
0.48
"We demonstrate a safe and effective inpatient bowel preparation regimen in a SCI population."( A safe and effective multi-day colonoscopy bowel preparation for individuals with spinal cord injuries.
Burns, SP; Dominitz, JA; Song, SH; Svircev, JN; Teng, BJ, 2018
)
0.48
" No medication-related adverse events were reported."( Efficacy and Safety of Sodium Picosulfate/Magnesium Citrate for Bowel Preparation in a Physically Disabled Outpatient Population: A Randomized, Endoscopist-Blinded Comparison With Ascorbic Acid-Enriched Polyethylene Glycol Solution Plus Bisacodyl (The PIC
Mathus-Vliegen, EMH; Stadwijk, JS; van der Vliet, K; Wignand-van der Storm, IJ, 2018
)
0.48
" The grade of bowel preparation and any related side effect were evaluated."( Bowel Preparation for Gastrointestinal Endoscopic Procedures With Sodium Picosulphate-Magnesium Citrate Is an Effective, Safe, and Well-Tolerated Option in Pediatric Patients: A Single-Center Experience.
Andrealli, A; Barletti, C; Calvo, P; Cisarò, F; Guanà, R; Pinon, M,
)
0.13
"Magnesium citrate with sodium picosulfate is outstandingly effective, well tolerated and a safe agent in colonoscopy preparation."( Efficacy, tolerability and safety of a split-dose bowel cleansing regimen of magnesium citrate with sodium picosulfate - a phase IV clinical observational study.
Bálint, A; Bor, R; Fabián, A; Farkas, K; Matuz, M; Milassin, Á; Molnár, T; Pigniczki, D; Rutka, M; Szántó, K; Szepes, Z; Tóth, T, 2021
)
0.62

Compound-Compound Interactions

ExcerptReferenceRelevance
"Two hundred and ninety-one adults scheduled for routine sigmoidoscopy were randomly assigned to receive one of three preparations containing oral magnesium citrate (296 cc) taken the night before the procedure in combination with the following: 1) oral bisacodyl (10 mg), given with the magnesium citrate the night before the procedure; 2) one hypertonic phosphate enema 1 h before the procedure; or 3) two hypertonic phosphate enemas, given singly at 2 and 1 h before the procedure."( A comparison of bowel preparations for flexible sigmoidoscopy: oral magnesium citrate combined with oral bisacodyl, one hypertonic phosphate enema, or two hypertonic phosphate enemas.
Fincher, RK; Jackson, JL; Osgard, EM; Strong, JS; Wong, RK, 1999
)
0.3

Bioavailability

ExcerptReferenceRelevance
" No clinical studies have been published to investigate the ability of a cathartic, with or without activated charcoal, to reduce the bioavailability of drugs or to improve the outcome of poisoned patients."( Position statement: cathartics. American Academy of Clinical Toxicology; European Association of Poisons Centres and Clinical Toxicologists.
Barceloux, D; Hartigan-Go, K; McGuigan, M, 1997
)
0.3
"Published data on the bioavailability of various Mg preparations is too fragmented and scanty to inform proper choice of Mg preparation for clinical studies."( Mg citrate found more bioavailable than other Mg preparations in a randomised, double-blind study.
Byng, M; Christie, S; Marakis, G; Walker, AF, 2003
)
0.32
" No clinical studies have been published to investigate the ability of a cathartic, with or without activated charcoal, to reduce the bioavailability of drugs or to improve the outcome of poisoned patients."( Position paper: cathartics.
, 2004
)
0.32
" Bioavailability of 400 mg Mg from Mg citrate (MgC) and Mg oxide (MgO) after single-dose administration was assessed by measuring renal Mg excretion in 24-h urine and blood plasma [Mg] at time points 0, 2, 4, 8, and 24 h."( Assessment of bioavailability of Mg from Mg citrate and Mg oxide by measuring urinary excretion in Mg-saturated subjects.
Cibulka, M; Grendar, M; Kolisek, M; Pilchova, I; Struharnanska, E; Vormann, J; Werner, T, 2019
)
0.51
"MgC shows higher bioavailability compared with MgO."( Assessment of bioavailability of Mg from Mg citrate and Mg oxide by measuring urinary excretion in Mg-saturated subjects.
Cibulka, M; Grendar, M; Kolisek, M; Pilchova, I; Struharnanska, E; Vormann, J; Werner, T, 2019
)
0.51

Dosage Studied

ExcerptRelevanceReference
" Finally, parenteral Mg was discontinued as the dosage of oral Mg supplementation reached a level of 90 mg/kg/d elemental Mg citrate, without any gastrointestinal side effects."( Successful management of primary hypomagnesaemia with high-dose oral magnesium citrate: a case report.
Bircan, I; Dursun, O; Karaguzel, G; Turkkahraman, D, 2006
)
0.33
" Thus, during the regular follow-up of patients with primary hypomagnesaemia, the main target must be to increase oral Mg supplementation to a dosage which can maintain normocalcaemia rather than normomagnesaemia."( Successful management of primary hypomagnesaemia with high-dose oral magnesium citrate: a case report.
Bircan, I; Dursun, O; Karaguzel, G; Turkkahraman, D, 2006
)
0.33
" Patients were randomly divided into two groups: group A (Mg group), in which patients were given magnesium citrate orally at a dosage of 610 mg every other day for 2 months and group B (control group), in which patients received only calcium acetate therapy as a phosphate binder."( Magnesium supplementation helps to improve carotid intima media thickness in patients on hemodialysis.
Akcay, A; Covic, A; Kanbay, M; Metin, MR; Turgut, F; Uz, E, 2008
)
0.35
"Split dosage of bowel preparations has been shown to substantially improve bowel cleansing."( [Split-dose sodium picosulphate/magnesium citrate for morning colonoscopies performed 2 to 6 hours after fluid intake].
Dueñas-Sadornil, C; Fernández-Bermejo, M; González-Santiago, JM; Hernández-Alonso, M; Martín-Noguerol, E; Martínez-Alcalá, C; Mateos-Rodríguez, JM; Molina-Infante, J; Pérez-Gallardo, B; Vinagre-Rodríguez, G, 2013
)
0.39
" This study evaluates whether split dosing is associated with a further increase in efficacy and acceptability compared with the standard dosing regimen."( Randomized controlled trial comparing efficacy and acceptability of split- and standard-dose sodium picosulfate plus magnesium citrate for bowel cleansing prior to colonoscopy.
Hassan, C; Manes, G; Repici, A, 2014
)
0.4
" Adult outpatients undergoing colonoscopy received PMC either in the standard dosing (two sachets taken the day before endoscopy) or in split dosing (the second sachet taken on the morning of colonoscopy)."( Randomized controlled trial comparing efficacy and acceptability of split- and standard-dose sodium picosulfate plus magnesium citrate for bowel cleansing prior to colonoscopy.
Hassan, C; Manes, G; Repici, A, 2014
)
0.4
" Pediatric inpatients undergoing colonoscopy received SPMC either in the day-before dosing or in split dosing."( Split-dose versus day-before regimen of sodium picosulfate plus magnesium citrate for bowel cleansing before colonoscopy in children: Randomized controlled trial.
Di Nardo, G; Evangelisti, M; Felici, E; Furio, S; Hassan, C; Lucchini, L; Massolo, AC; Mennini, M; Parisi, P; Piccirillo, M; Quatrale, G; Strisciuglio, C; Zenzeri, L, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Occurs in Manufacturing (64 Product(s))

Product Categories

Product CategoryProducts
Pet Supplies6
Vitamins & Supplements21
Professional Supplements8
Active Lifestyle & Fitness27
Food & Beverages2

Products

ProductBrandCategoryCompounds Matched from IngredientsDate Retrieved
Alzoo Calming Supplement For Dogs Soft Chews Peanut Butter -- 90 Soft ChewsAlzooPet SuppliesMagnesium Citrate, Melatonin2024-11-29 10:47:42
Country Life Calcium Magnesium Caps -- 180 Vegan CapsulesCountry LifeVitamins & Supplements alpha-ketoglutarate, calcium citrate, magnesium citrate, Phosphorus2024-11-29 10:47:42
Country Life Daily Total One™ Iron Free -- 60 Vegetarian CapsulesCountry LifeVitamins & Supplements ascorbyl palmitate, Vitamin C, beta carotene, Betaine, Biotin, Boron, calcium ascorbate, calcium citrate, d-calcium pantothenate, di-calcium phosphate, Chromium, Vitamin E, riboflavin 5' phosphate, Folate, Vitamin E, inositol hexanicotinate, Inositol, magnesium citrate, Manganese, Molybdenum, Niacin, niacinamide, pantethine, Pantothenic Acid, Phosphorus, pyridoxal 5' phosphate, pyridoxine hydrochloride, Vitamin B6, retinyl palmitate, Vitamin A, Riboflavin, Selenium, thiamine hydrochloride, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Country Life Magnesium with Silica -- 300 mg - 120 Vegan CapsulesCountry LifeVitamins & Supplements magnesium citrate2024-11-29 10:47:42
Country Life Target-Mins™ Magnesium Potassium Aspartate -- 180 TabletsCountry LifeVitamins & Supplements magnesium citrate, potassium citrate2024-11-29 10:47:42
Double Wood Supplements Magnesium Citrate -- 800 mg - 180 CapsulesDouble Wood SupplementsProfessional SupplementsMagnesium Citrate2024-11-29 10:47:42
Enzyme Science Digest Gold -- 240 CapsulesEnzyme ScienceProfessional Supplements CoQ10, Magnesium citrate, Alpha Lipoic Acid2024-11-29 10:47:42
Enzyme Science Digest Gold -- 90 CapsulesEnzyme ScienceProfessional Supplements CoQ10, Magnesium citrate, Alpha Lipoic Acid2024-11-29 10:47:42
Enzymedica pH-Basic -- 120 CapsulesEnzymedicaVitamins & Supplements Magnesium Citrate2024-11-29 10:47:42
Force Factor Magnesium -- 500 mg - 90 Vegetable CapsulesForce FactorVitamins & Supplements Magnesium Citrate2024-11-29 10:47:42
Integrative Therapeutics Tri-Magnesium -- 90 CapsulesIntegrative TherapeuticsProfessional Supplementscellulose, magnesium citrate2024-11-29 10:47:42
Kaged Hydra-Charge - Informed Sport Certified Orange Mango -- 60 ServingsKagedActive Lifestyle & Fitness Citric acid, beta-carotene, tricalcium citrate tetrahydrate, Citric acid, magnesium citrate, Phosphorus, sodium citrate, tartaric acid, Taurine, sucralose2024-11-29 10:47:42
Kal Magnesium -- 400 mg - 60 TabletsKALVitamins & Supplementscellulose, magnesium citrate, magnesium orotate2024-11-29 10:47:42
Life Extension Potassium with Extend-Release Magnesium -- 60 Vegetarian CapsulesLife ExtensionVitamins & Supplementsethylcellulose, microcrystalline cellulose, magnesium citrate, oleic acid2024-11-29 10:47:42
Liquid Health Calcium and Magnesium Juicy Orange & Vanilla -- 32 fl ozLiquid HealthVitamins & Supplementscitric acid, Boron, Calcium citrate, Vitamin D3, citric acid, Magnesium citrate, Manganese2024-11-29 10:47:42
MegaFood Magnesium 300mg Blend of Magnesium Glycinate Citrate & Malate -- 60 CapsulesMegaFoodVitamins & Supplementsascorbyl palmitate, magnesium citrate2024-11-29 10:47:42
MegaFood Relax + Calm Magnesium Powder - Magnesium Glycinate Citrate & Malate Blackberry Hibiscus Oasis -- 7.05 ozMegaFoodVitamins & Supplementscitric acid, citric acid, magnesium citrate, Maltodextrin2024-11-29 10:47:42
MegaFood Relax + Calm Magnesium Powder - Magnesium Glycinate Citrate & Malate Raspberry Lemonade -- 7.05 ozMegaFoodVitamins & Supplementscitric acid, citric acid, magnesium citrate, Maltodextrin2024-11-29 10:47:42
NutraChamps Magnesium Zinc & Vitamin D3 -- 120 Veggie CapsulesNutraChampsVitamins & SupplementsVitamin D3, Magnesium Citrate2024-11-29 10:47:42
Nutricost Magnesium Complex -- 500 mg - 240 CapsulesNutricostVitamins & Supplementsmicrocrystalline cellulose, magnesium citrate2024-11-29 10:47:42
NUUN Endurance - Informed Sport Certified - Canister Lemon Lime -- 11 ozNUUNActive Lifestyle & Fitnesscitric acid, Chloride, citric acid, magnesium citrate, potassium chloride, potassium citrate, sodium citrate, Cane sugar2024-11-29 10:47:42
NUUN Endurance - Informed Sport Certified - Canister Strawberry Lemonade -- 11 ozNUUNActive Lifestyle & Fitnesscitric acid, calcium citrate, Chloride, citric acid, magnesium citrate, potassium chloride, potassium citrate, sodium citrate, Cane sugar2024-11-29 10:47:42
NUUN Endurance - Informed Sport Certified - Sachet Box Lemon Lime -- 12 PacketsNUUNActive Lifestyle & Fitnesscitric acid, Chloride, citric acid, magnesium citrate, potassium chloride, potassium citrate, sodium citrate, Cane sugar2024-11-29 10:47:42
Pirq Electrolyte Drink Mix - Hydration Powder Packets Fruit Punch -- 10 PacketsPirqActive Lifestyle & Fitness Citric acid, calcium ascorbate, D-calcium pantothenate, Chloride, Citric acid, curcumin, Vitamin E, Vitamin E, magnesium citrate, malic acid, Niacin, niacinamide, Pantothenic Acid, potassium citrate, Vitamin B122024-11-29 10:47:42
Pirq Electrolyte Drink Mix - Hydration Powder Packets Lemon Lime -- 10 PacketsPirqActive Lifestyle & Fitnesscitric acid, calcium ascorbate, D-calcium pantothenate, Chloride, citric acid, curcumin, Vitamin E, Vitamin E, magnesium citrate, malic acid, Niacin, niacinamide, Pantothenic Acid, potassium citrate, Vitamin B122024-11-29 10:47:42
Pirq Electrolyte Drink Mix - Hydration Powder Packets Orange -- 10 PacketsPirqActive Lifestyle & Fitness Citric acid, beta carotene, calcium ascorbate, D-calcium pantothenate, Chloride, Citric acid, curcumin, Vitamin E, vitamin E, magnesium citrate, malic acid, Niacin, niacinamide, Pantothenic Acid, potassium citrate, Vitamin B122024-11-29 10:47:42
Pirq Electrolyte Drink Mix - Hydration Powder Packets Watermelon -- 10 PacketsPirqActive Lifestyle & Fitness Citric acid, calcium ascorbate, D-calcium pantothenate, Chloride, Citric acid, curcumin, Vitamin E, Vitamin E, magnesium citrate, malic acid, Niacin, niacinamide, Pantothenic Acid, potassium citrate, Vitamin B122024-11-29 10:47:42
Solaray Cal-Mag Citrate -- 180 VegCapsSolarayVitamins & SupplementsCalcium Citrate, Magnesium Citrate2024-11-29 10:47:42
Solaray Calcium Magnesium Zinc -- 250 VegCapsSolarayVitamins & Supplements Calcium Citrate, Calcium Carbonate, Magnesium Citrate2024-11-29 10:47:42
Solaray Magnesium and Potassium Asporotates™ with Bromelain -- 120 Vegetarian CapsulesSolarayVitamins & Supplementscellulose, Magnesium Citrate, maltodextrin, Potassium Citrate2024-11-29 10:47:42
Solaray Magnesium Asporotate -- 180 CapsulesSolarayVitamins & Supplements Magnesium Citrate2024-11-29 10:47:42
SOS Hydration Daily Hydration Electrolytes Mixed Berry -- 31 ServingsSOS HydrationActive Lifestyle & Fitnesscitric acid, Vitamin C, Chloride, vitamin D3, citric acid, Folate, magnesium citrate, potassium chloride, Vitamin B6, rebaudioside A, sodium citrate, Sugar, cyanocobalamin, vitamin B6, zinc sulfate2024-11-29 10:47:42
SOS Hydration Daily Hydration Electrolytes Mixed Berry -- 8 SticksSOS HydrationActive Lifestyle & Fitnesscitric acid, Vitamin C, Chloride, vitamin D3, citric acid, Folate, magnesium citrate, potassium chloride, Vitamin B6, rebaudioside A, sodium citrate, Sugar, cyanocobalamin, vitamin B6, zinc sulfate2024-11-29 10:47:42
Source Naturals Ultra-Mag™ -- 120 TabletsSource NaturalsVitamins & Supplementsmagnesium citrate, Vitamin B6, Stearic acid, Vitamin B62024-11-29 10:47:42
Source Naturals Ultra-Mag™ -- 240 TabletsSource NaturalsVitamins & Supplementsmagnesium citrate, Vitamin B6, Stearic acid, Vitamin B62024-11-29 10:47:42
Sunshine Beverages Sparkling Energy Drink Blueberry Lemonade -- 4 CansSunshine BeveragesFood & Beveragescitric acid, calcium lactate, calcium pantothenate, citric acid, magnesium citrate, malic acid, maltodextrin, niacinamide, Pantothenic Acid, potassium citrate, pyridoxine hydrochloride, Vitamin B6, cane sugar, Vitamin B12, Vitamin B62024-11-29 10:47:42
Sunshine Beverages Sparkling Energy Drink Ginger Berry -- 4 CansSunshine BeveragesFood & Beveragescitric acid, calcium lactate, citric acid, magnesium citrate, malic acid, cane sugar, Vitamin B122024-11-29 10:47:42
Thin Energy Hydration Plant-Based Drink Packets Mango Ginger -- 30 PacketsThin EnergyActive Lifestyle & Fitnesscitric acid, citric acid, magnesium citrate2024-11-29 10:47:42
Thin Energy Hydration Plant-Based Drink Packets Passion Fruit Elderberry -- 30 PacketsThin EnergyActive Lifestyle & Fitnesscitric acid, citric acid, magnesium citrate2024-11-29 10:47:42
Thorne Research Basic B Complex -- 60 CapsulesThorne ResearchProfessional SupplementsBiotin, Choline, Folate, microcrystalline cellulose, leucine, magnesium citrate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Thorne Research PharmaGABA-100 -- 60 CapsulesThorne ResearchProfessional SupplementsGamma-Aminobutyric Acid, Microcrystalline cellulose, magnesium citrate2024-11-29 10:47:42
Thorne Research PharmaGABA-250 -- 60 CapsulesThorne ResearchProfessional SupplementsGamma-Aminobutyric Acid, Microcrystalline cellulose, magnesium citrate2024-11-29 10:47:42
Trace Minerals Research Liquid Cal/Mag/Zinc Natural Strawberry -- 32 fl ozTrace Minerals ResearchVitamins & Supplementscitric acid, Boron, Calcium Citrate, Chloride, Vitamin D3, citric acid, Glycerol, Magnesium Citrate, phosphoric acid, Phosphorus, Tri-Calcium phosphate2024-11-29 10:47:42
TransformHQ Perform BCAAs - 28 Servings Raspberry Lemonade -- 13.7 ozTransformHQActive Lifestyle & Fitnessisoleucine, Calcium Carbonate, Magnesium Citrate2024-11-29 10:47:42
TransformHQ Perform Pre-Workout - 28 Servings Blue Raspberry -- 13.3 ozTransformHQActive Lifestyle & FitnessBeta-Alanine, Chloride, Calcium Carbonate, Magnesium Citrate, Phosphorus, Taurine2024-11-29 10:47:42
Type Zero Clean Amino Burn Pina Colada -- 30 ServingsType ZeroActive Lifestyle & Fitnesscitric acid, citric acid, Erythritol, L-Glutamine, L-Isoleucine, magnesium citrate, malic acid, potassium chloride, sodium citrate, Sugar, L-Valine2024-11-29 10:47:42
Type Zero Clean Amino Burn Watermelon Rush -- 30 ServingsType ZeroActive Lifestyle & Fitnesscitric acid, citric acid, Erythritol, L-Glutamine, L-Isoleucine, magnesium citrate, malic acid, potassium chloride, sodium citrate, Sugar, L-Valine2024-11-29 10:47:42
Ultima Replenisher Electrolyte Powder Grape -- 90 ServingsUltima ReplenisherActive Lifestyle & Fitnesscitric acid, Vitamin C, calcium ascorbate, Chloride, citric acid, Magnesium citrate, Phosphorus, potassium phosphate, rebaudioside-A, tartaric acid2024-11-29 10:47:42
Ultima Replenisher Electrolyte Powder Orange -- 20 PacketsUltima ReplenisherActive Lifestyle & Fitness Citric acid, Vitamin C, beta-carotene, calcium ascorbate, calcium citrate, Chloride, Citric acid, magnesium citrate, Manganese, Phosphorus, potassium phosphate, rebaudioside-A2024-11-29 10:47:42
Ultima Replenisher Electrolyte Powder Orange -- 30 ServingsUltima ReplenisherActive Lifestyle & Fitness Citric acid, Vitamin C, beta-carotene, calcium ascorbate, calcium citrate, Chloride, Citric acid, magnesium citrate, Manganese, Phosphorus, potassium phosphate, rebaudioside-A2024-11-29 10:47:42
Ultima Replenisher Electrolyte Powder Orange -- 90 ServingsUltima ReplenisherActive Lifestyle & Fitness Citric acid, Vitamin C, beta-carotene, calcium ascorbate, calcium citrate, Chloride, Citric acid, magnesium citrate, Phosphorus, potassium phosphate, rebaudioside-A2024-11-29 10:47:42
Ultima Replenisher Electrolyte Powder Raspberry -- 30 ServingsUltima ReplenisherActive Lifestyle & Fitnesscitric acid, Vitamin C, calcium ascorbate, calcium citrate, Chloride, citric acid, Magnesium citrate, malic acid, Manganese, Phosphorus, potassium phosphate, rebaudioside-A2024-11-29 10:47:42
Ultima Replenisher Hydration Electrolyte Raspberry -- 90 ServingsUltima ReplenisherActive Lifestyle & Fitnesscitric acid, Vitamin C, calcium ascorbate, calcium citrate, calcium lactate, Chloride, citric acid, Magnesium citrate, malic acid, Manganese, Phosphorus, potassium phosphate, rebaudioside A2024-11-29 10:47:42
Ultima Replenisher Hydration Electrolyte Canister Drink Mix Blue Raspberry -- 90 ServingsUltima ReplenisherActive Lifestyle & Fitnesscitric acid, Vitamin C, calcium ascorbate, calcium citrate, Chloride, citric acid, Magnesium citrate, malic acid, Manganese, Phosphorus, potassium phosphate, rebaudioside A2024-11-29 10:47:42
Ultima Replenisher Hydration Electrolyte Canister Drink Mix Passionfruit -- 90 ServingsUltima ReplenisherActive Lifestyle & Fitnesscitric acid, Vitamin C, calcium ascorbate, calcium citrate, Chloride, citric acid, Magnesium citrate, malic acid, Manganese, Phosphorus, potassium phosphate, rebaudioside A2024-11-29 10:47:42
Ultima Replenisher Hydration Electrolyte Canister Drink Mix Pink Lemonade -- 90 ServingsUltima ReplenisherActive Lifestyle & Fitness Citric acid, Vitamin C, calcium ascorbate, calcium citrate, Chloride, Citric acid, magnesium citrate, Manganese, Phosphorus, potassium phosphate, rebaudioside A2024-11-29 10:47:42
Ultima Replenisher Hydration Electrolyte Canister Drink Mix Watermelon -- 90 ServingsUltima ReplenisherActive Lifestyle & Fitnesscitric acid, Vitamin C, calcium ascorbate, calcium citrate, Chloride, citric acid, Magnesium citrate, malic acid, Manganese, Phosphorus, potassium phosphate, rebaudioside A2024-11-29 10:47:42
Ultima Replenisher Hydration Electrolyte Mocktini Variety Pack -- 20 PacksUltima ReplenisherActive Lifestyle & Fitnesscitric acid, Vitamin C, beta carotene, calcium ascorbate, calcium citrate, Chloride, citric acid, magnesium citrate, malic acid, Manganese, Phosphorus, potassium phosphate2024-11-29 10:47:42
Vital Nutrients NAC N-Acetyl Cysteine - Antioxidant Support -- 600 mg - 200 Vegan CapsulesVital NutrientsProfessional SupplementsN-Acetyl-L-Cysteine, leucine, magnesium citrate2024-11-29 10:47:42
Zesty Paws Advanced Calming Bites Behavior Supplement Dogs Turkey -- 90 Soft ChewsZesty PawsPet SuppliesCitric acid, Citric acid, powdered cellulose, Magnesium Citrate, Melatonin, Thiamine2024-11-29 10:47:42
Zesty Paws Hemp Calming Composure Supplement for Dogs Peanut Butter -- 90 Soft ChewsZesty PawsPet Suppliescitric acid, citric acid, powdered cellulose, Magnesium Citrate, ashwagandha2024-11-29 10:47:42
Zesty Paws Hemp Calming Composure Supplement for Dogs Turkey -- 90 Soft ChewsZesty PawsPet SuppliesCitric acid, Citric acid, powdered cellulose, Magnesium Citrate, Thiamine2024-11-29 10:47:42
Zesty Paws Hemp Elements Calming Orastix Dental Chews for Dogs Peppermint -- 12 ozZesty PawsPet Suppliescitric acid, Chamomile, Kelp, citric acid, lactic acid, Magnesium Citrate, Melatonin, sorbic acid, Taurine2024-11-29 10:47:42
Zesty Paws Hemp Elements Calming Orastix Dental Chews for Dogs Peppermint -- 25 ozZesty PawsPet Suppliescitric acid, Chamomile, Kelp, citric acid, lactic acid, Magnesium Citrate, Melatonin, sorbic acid, Taurine2024-11-29 10:47:42

Roles (1)

RoleDescription
laxativeAn agent that produces a soft formed stool, and relaxes and loosens the bowels, typically used over a protracted period, to relieve constipation. Compare with cathartic, which is a substance that accelerates defecation. A substances can be both a laxative and a cathartic.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (1)

ClassDescription
magnesium salt
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Research

Studies (177)

TimeframeStudies, This Drug (%)All Drugs %
pre-19903 (1.69)18.7374
1990's16 (9.04)18.2507
2000's50 (28.25)29.6817
2010's91 (51.41)24.3611
2020's17 (9.60)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials88 (44.90%)5.53%
Reviews16 (8.16%)6.00%
Case Studies26 (13.27%)4.05%
Observational4 (2.04%)0.25%
Other62 (31.63%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (43)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
The Effects of Magnesium Salts on Vascular Stiffness: A Randomized Controlled Trial in Healthy Overweight and Slightly Obese Men and Women [NCT03632590]162 participants (Anticipated)Interventional2018-03-27Recruiting
Magnesium Deficiency In Patients Hospitalized in Internal Medicine Wards [NCT03088852]Phase 4330 participants (Anticipated)Interventional2017-05-10Recruiting
Comparison of Efficiency and Tolerance of Sodium Picosulphate/ Magnesium Citrate, Polyethylene Glycol/Ascorbate and Oral Sulfate Solution Before Colonoscopy [NCT03698474]Phase 4612 participants (Actual)Interventional2018-10-25Completed
A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of RMJH-111b in Adult Subjects With Essential Hypertension [NCT02822222]Phase 1/Phase 222 participants (Actual)Interventional2016-06-10Completed
PRECOL2011-1: Sodium Picophosphate and Magnesium Citrate Versus Polyethylene Glycol as Evacuating Treatment Prior to Colonoscopy: Phase IV Randomized Trial. [NCT01649674]Phase 4525 participants (Anticipated)Interventional2011-11-30Active, not recruiting
Effects of Magnesium Supplementation on Hemodynamic Parameters and Cognitive Function [NCT03716609]50 participants (Actual)Interventional2018-10-23Completed
Effervescent Calcium Magnesium Citrate to Prevent Mineral Metabolism and Renal Complications of Chronic Proton Pump Inhibitor Therapy [NCT05998863]Phase 356 participants (Anticipated)Interventional2024-01-01Not yet recruiting
A Head-to-head Comparison of Efficiency and Tolerance of 4-L Polyethylene Glycol and Sodium Picosulphate/ Magnesium Citrate, Polyethylene Glycol/Ascorbate Before Colonoscopy [NCT02956057]Phase 41,044 participants (Actual)Interventional2016-11-12Completed
Magnesium Supplements, Plasma Inflammatory Markers, and Gene Expression in Overweight Individuals With Metabolic Syndrome: a Randomized , Controlled Crossover Trial [NCT00737815]14 participants (Actual)Interventional2007-06-30Completed
The Effects of Magnesium on Vascular Stiffness: A Long-term Study in Healthy Overweight and Slightly Obese Men and Women [NCT02235805]52 participants (Actual)Interventional2014-09-30Completed
Investigation of Choice Alteration of the Gut Metagenome on COVID-19 Severity [NCT04941703]Phase 1/Phase 223 participants (Actual)Interventional2021-11-04Terminated(stopped due to Recruitment issues after COVID-19 abated; not enough hypoxic patients to meet criteria.)
Preventing Metabolic Side Effects of Thiazide Diuretics With KMgCitrate [NCT02665117]61 participants (Actual)Interventional2015-01-31Completed
Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for the Management of Hypomagnesemia From Anti-Cancer Therapies [NCT02690012]15 participants (Actual)Interventional2016-07-31Completed
Bioavailability of Single-dose Magnesium Salts [NCT04139928]42 participants (Anticipated)Interventional2018-08-01Recruiting
Potential Therapeutic Role of Effervescent Calcium-Magnesium Citrate in Chronic Kidney Disease Stage V [NCT03565913]Phase 2/Phase 3245 participants (Anticipated)Interventional2017-01-22Recruiting
The Effect of Magnesium Citrate Supplementation in Patients With Restless Legs Syndrome (RLS) - An Open Label, Prospective, Non Placebo Controlled Pilot Study [NCT04462796]15 participants (Anticipated)Interventional2020-07-10Recruiting
Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing [NCT04598880]Phase 41,104 participants (Anticipated)Interventional2020-11-06Recruiting
The Absorption of Supplemental Magnesium Oxide Compared to Magnesium Citrate in Healthy Subjects With no Apparent Heart Disease [NCT00994006]Phase 441 participants (Actual)Interventional2010-01-31Completed
Averting Complications of Proton Pump Inhibitor Therapy by Effervescent Calcium Magnesium Citrate [NCT03812380]Phase 362 participants (Actual)Interventional2019-01-01Terminated(stopped due to The study was terminated due to a severe decrease in enrollment over the years 2020 and 2021. The major obstacle which hindered participation of subjects was the COVID-19 pandemic. Research was halted. Remaining study patients were withdrawn.)
A Randomized Controlled Trial Comparing Efficacy and Acceptability of Split and Standard Dose Sodium Picosulphate/Magnesium Citrate for Bowel Cleansing Prior to Colonoscopy: the MAGIC-P Multicenter Study [NCT01909219]Phase 4862 participants (Actual)Interventional2012-01-31Completed
A Comparison of Bowel Prep Quality and Patient Satisfaction in Outpatients Undergoing Colonoscopy Preparation With Either a Standard Bowel Preparation or an Individualized Approach Using Sodium Picosulphatge/Magnesium Citrate or 4L Polyethylene Glycol Pre [NCT02024022]Phase 4185 participants (Actual)Interventional2014-02-28Completed
A Randomized Clinical Trial of Oral Magnesium Supplementation In Pregnancy for the Prevention of Preterm Birth and Perinatal and Maternal Morbidity [NCT02032186]Phase 33,000 participants (Actual)Interventional2014-03-31Completed
RELISTOR's Effects on Opioid-Induced Constipation in Postoperative 1-2 Level Anterior Lumbar Interbody Fusion Patients: A Case-Control Study [NCT04930237]0 participants (Actual)Observational2021-07-01Withdrawn(stopped due to PI request to close study)
Better Evidence and Translation for Calciphylaxis [NCT05018221]Phase 3350 participants (Anticipated)Interventional2021-08-26Recruiting
A Randomized Prospective Trial Comparing Pico-Salax (Magnesium Citrate) Plus Bisacodyl Versus Split Dose Polyethylene Glycol-Based Lavage In Preparation Of Patients For Colonoscopy [NCT01415687]Phase 3171 participants (Actual)Interventional2011-05-31Completed
A Randomised, Single-Centre, Parallel-Group, Pilot Study to Assess the Efficacy, Safety and Patient Acceptability of a New 2-Litre Bowel Preparation Agent (MOVIPREP®) Compared With a Standard Bowel Preparation Agent (PICOLAX®) [NCT00312481]Phase 265 participants (Actual)Interventional2005-07-31Completed
Value of Potassium Magnesium Citrate in Preventing and Treating Hypertension in African Americans [NCT05145309]Phase 245 participants (Anticipated)Interventional2024-03-15Not yet recruiting
Diuresis Efficacy in Ambulatory Chronic Heart Failure Patients With Volume Overload- Intra -Patient Comparison of Three Diuretics Regimens [NCT05904808]Phase 442 participants (Actual)Interventional2023-04-19Active, not recruiting
Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension [NCT02653560]Phase 430 participants (Actual)Interventional2012-09-30Completed
A Randomized Controlled Trial Comparing the Efficacy and Acceptability of Sodium Picosulphate/Magnesium Citrate With Low-volume PEG -Ascorbic Acid as Preparation for Colonoscopy. [NCT01603654]Phase 4300 participants (Actual)Interventional2011-01-31Completed
Magnesium Supplementation in the Second Trimester of Pregnancy for Overweight Individuals [NCT01510665]28 participants (Actual)Interventional2012-01-31Completed
A Randomized Prospective Trial Comparing Different Regimens of Polyethylene Glycol-based Lavage and Sodium Picosulphate With Magnesium Citrate in the Preparation of Patients for Colonoscopy [NCT01778192]Phase 3200 participants (Actual)Interventional2012-07-31Completed
Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy [NCT01805310]Phase 495 participants (Actual)Interventional2013-02-28Completed
Effects of a 12-week Supplementation With 400 mg Magnesium From Magnesium Citrate on Blood Sugar, Blood Pressure and Expression of Magnesium-sensitive Genes in Patients With Type II Diabetes [NCT03002545]50 participants (Actual)Interventional2016-12-31Completed
Comparison the Efficacy Depending on the Order of the Sequential Combination Method Using Sodium Picosulfate and Magnesium Citrate (PMC) and PEG With Ascorbic Acid for Bowel Preparation (The Phase II Prospective Randomized Clinical Trial) [NCT02979223]Phase 2142 participants (Actual)Interventional2016-11-30Completed
Impact of Naloxegol on Prevention of Lower GI Tract Paralysis in Critically Ill Adults Initiated on Scheduled Intravenous Opioid Therapy: A Randomized, Double-Blind, Placebo-Controlled, Phase II, Single-Center, Proof of Concept Study [NCT02977286]Phase 412 participants (Actual)Interventional2017-01-01Terminated(stopped due to Poor enrollment)
Efficacy of Magnesium Citrate Capsules in Colonoscopy Preparation: A Randomized, Investigator-blinded Non-inferiority Trial Using Polyethylene Glycol as the Active Control. [NCT03247595]62 participants (Actual)Interventional2017-09-26Completed
Microbiota Transfer Therapy for Children With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders [NCT04132427]Phase 27 participants (Actual)Interventional2019-09-30Completed
Citrate Salts for Stone-free Result After Flexible Ureterorenoscopy for Inferior Calyx Calculi: a Randomized Placebo Controlled Trial [NCT04021381]Phase 3262 participants (Anticipated)Interventional2020-09-25Recruiting
To Explore the Regulatory Effect of Magnesium on Intestinal Flora in Healthy Adults # A Single-center, Prospective, Self-controlled Trial [NCT05597150]41 participants (Actual)Interventional2022-10-15Completed
The Impact of Magnesium Supplementation on the Clinical Outcome of Patients of Diabetic Nephropathy [NCT03824379]Phase 260 participants (Actual)Interventional2019-06-01Completed
Tolerability and Efficacy of Low-Volume Sodium Picosulfate/Magnesium Citrate Versus 2L Polyethylene Glycol/Ascorbic Acid in Patients With Ulcerative Colitis Undergoing Colonoscopy: A Randomized Controlled Trial [NCT03581149]Phase 468 participants (Anticipated)Interventional2018-03-26Recruiting
Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension [NCT01682837]Phase 235 participants (Actual)Interventional2012-10-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT01682837 (9) [back to overview]Central Aortic Diastolic Blood Pressure
NCT01682837 (9) [back to overview]Carotid to Femoral Pulse Wave Velocity
NCT01682837 (9) [back to overview]24-hour Urinary Calcium
NCT01682837 (9) [back to overview]24-hour Average Systolic Blood Pressure
NCT01682837 (9) [back to overview]Serum C-terminal Telopeptide (CTX)
NCT01682837 (9) [back to overview]24-hour Average Diastolic Blood Pressure
NCT01682837 (9) [back to overview]Central Aortic Systolic Blood Pressure
NCT01682837 (9) [back to overview]Office Diastolic Blood Pressure
NCT01682837 (9) [back to overview]Office Systolic Blood Pressure
NCT02653560 (1) [back to overview]24-hour Average Systolic Blood Pressure
NCT02665117 (4) [back to overview]Chang in Hepatic Fat Measured at Baseline and Week 16
NCT02665117 (4) [back to overview]Change in Fasting Plasma Glucose From Week 4 to Week 16
NCT02665117 (4) [back to overview]Change in FGF23 From Week 4 to Week 16
NCT02665117 (4) [back to overview]Change in Muscle Magnesium Content Measured at Baseline and Week 16
NCT02822222 (22) [back to overview]Efficacy of RMJH-111b Compared to Placebo Based on Change From Baseline in DBPnight After 7 Days of Treatment
NCT02822222 (22) [back to overview]Efficacy of RMJH-111b Compared to Placebo Based on Change From Baseline in SBP24hr After 7 Days of Treatment
NCT02822222 (22) [back to overview]Efficacy of RMJH-111b Compared to Placebo Based on Change From Baseline in SBPday After 7 Days of Treatment
NCT02822222 (22) [back to overview]Efficacy of RMJH-111b Compared to Placebo Based on Change From Baseline in SBPnight After 7 Days of Treatment
NCT02822222 (22) [back to overview]Efficacy of RMJH-111b Compared to Placebo Based on Change From Baseline in Seated DBP After 7 Days of Treatment
NCT02822222 (22) [back to overview]Efficacy of RMJH-111b Compared to Placebo Based on Change From Baseline in Seated SBP After 7 Days of Treatment
NCT02822222 (22) [back to overview]Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in 12-lead ECG Ventricular Rate (After Last Dose)
NCT02822222 (22) [back to overview]Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in 24-hour Urinary Magnesium Excretion
NCT02822222 (22) [back to overview]Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in Body Weight
NCT02822222 (22) [back to overview]Pharmacokinetics of Total Serum Magnesium After Single and Repeated Oral Administrations of RMJH-111b Compared to Placebo Based on AUC
NCT02822222 (22) [back to overview]Pharmacokinetics of Total Serum Magnesium After Single and Repeated Oral Administrations of RMJH-111b Compared to Placebo Based on Trough Concentration Ratio
NCT02822222 (22) [back to overview]Pharmacokinetics of Urine Magnesium After Single and Repeated Oral Administrations of RMJH-111b Compared to Placebo Based on 24-hour Urinary Excretion
NCT02822222 (22) [back to overview]Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in 12-lead ECG Diagnosis (3 Hours After 1st Dose)
NCT02822222 (22) [back to overview]Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in 12-lead ECG Diagnosis (After Last Dose)
NCT02822222 (22) [back to overview]Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in 12-lead ECG Intervals (3 Hours After 1st Dose)
NCT02822222 (22) [back to overview]Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in 12-lead ECG Intervals (After Last Dose)
NCT02822222 (22) [back to overview]Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in Patellar Reflex Score
NCT02822222 (22) [back to overview]Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in Seated SBP and DBP
NCT02822222 (22) [back to overview]Safety and Tolerability of RMJH-111b Compared to Placebo Based on Treatment Emergent Adverse Events (TEAEs)
NCT02822222 (22) [back to overview]Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in 12-lead ECG Ventricular Rate (3 Hours After 1st Dose)
NCT02822222 (22) [back to overview]Efficacy of RMJH-111b Compared to Placebo Based on Change From Baseline in DBP24hr After 7 Days of Treatment
NCT02822222 (22) [back to overview]Efficacy of RMJH-111b Compared to Placebo Based on Change From Baseline in DBPday After 7 Days of Treatment
NCT02956057 (2) [back to overview]Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2)
NCT02956057 (2) [back to overview]Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2)
NCT02977286 (17) [back to overview]Average Daily Opioid Requirement [in IV Fentanyl Equivalents (mcg Per Day)]
NCT02977286 (17) [back to overview]Daily Difference in the Pre-dose and Post-dose Clinical Opioid Withdrawal Scale (COWS) Score
NCT02977286 (17) [back to overview]Daily Fluid Balance
NCT02977286 (17) [back to overview]Daily Maximal Pain Scale Score
NCT02977286 (17) [back to overview]Daily Maximal Sedation Assessment Scale (SAS) Score
NCT02977286 (17) [back to overview]Daily Presence of Delirium Using the Intensive Care Delirium Screening Checklist (ICDSC)
NCT02977286 (17) [back to overview]Days Without Mechanical Ventilation Support for Duration of ICU Stay
NCT02977286 (17) [back to overview]ICU Days Without a SBM
NCT02977286 (17) [back to overview]Number of Patients With Loose and Unformed or Liquid SBM
NCT02977286 (17) [back to overview]Occurrence of Lower GI Tract Paralysis (≥3 Days Without a SBM)
NCT02977286 (17) [back to overview]Occurrence of Lower GI Tract Paralysis Requiring GI/Surgical Consultation
NCT02977286 (17) [back to overview]Percentage of Daily Goal Reached for Enteral Nutrition Administration
NCT02977286 (17) [back to overview]Time to First Episode of Diarrhea
NCT02977286 (17) [back to overview]Time to First Spontaneous Bowel Movement (SBM)
NCT02977286 (17) [back to overview]Time to First Spontaneous Bowel Movement (SBM) Administration
NCT02977286 (17) [back to overview]Abdominal Pressure Measurement
NCT02977286 (17) [back to overview]Number of Patients That Required Use of the Study Laxative Protocol
NCT03812380 (10) [back to overview]Change From Baseline in the Fractional Excretion of Magnesium (FEMg) at 2 Years
NCT03812380 (10) [back to overview]Change From Baseline in Urine Magnesium at 2 Years
NCT03812380 (10) [back to overview]Change From Baseline in Bone Mineral Density (BMD) T-Score at 2 Years
NCT03812380 (10) [back to overview]Change From Baseline in Bone Mineral Density (BMD) Z-Score at 2 Years
NCT03812380 (10) [back to overview]Change From Baseline in Serum Bicarbonate at 2 Years
NCT03812380 (10) [back to overview]Change From Baseline in Free Muscle Magnesium at 2 Years
NCT03812380 (10) [back to overview]Change From Baseline in Serum Bone Resorption Marker C-terminal Telopeptide (CTX) at 2 Years
NCT03812380 (10) [back to overview]Change From Baseline in Endogenous Creatinine Clearance at 2 Years
NCT03812380 (10) [back to overview]Change From Baseline in Serum Magnesium at 2 Years
NCT03812380 (10) [back to overview]Change From Baseline in Serum Parathyroid Function (PTH) at 2 Years
NCT04941703 (2) [back to overview]COVID Ordinal Outcome Scale
NCT04941703 (2) [back to overview]Change in Oxygen Requirements From Baseline to Day 7 by Treatment Group

Central Aortic Diastolic Blood Pressure

(NCT01682837)
Timeframe: 4 weeks

InterventionmmHg (Mean)
Potassium Magnesium Citrate Powder Phase77
Potassium Citrate Powder Phase76
Potassium Chloride Powder Phase77
Placebo Phase79

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Carotid to Femoral Pulse Wave Velocity

(NCT01682837)
Timeframe: 4 weeks

Interventionm/s (Mean)
Potassium Magnesium Citrate Powder Phase8.7
Potassium Citrate Powder Phase8.8
Potassium Chloride Powder Phase8.7
Placebo Phase8.9

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24-hour Urinary Calcium

(NCT01682837)
Timeframe: 4 weeks of treatment

Interventionmg/day (Mean)
Potassium Magnesium Citrate Powder Phase158
Potassium Citrate Powder Phase148
Potassium Chloride Powder Phase160
Placebo Phase181

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24-hour Average Systolic Blood Pressure

This is the average systolic blood pressure over a 24 hour period. (NCT01682837)
Timeframe: 4 weeks

InterventionmmHg (Mean)
Potassium Magnesium Citrate Powder Phase127
Potassium Citrate Powder Phase127
Potassium Chloride Powder Phase126
Placebo Phase129

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Serum C-terminal Telopeptide (CTX)

(NCT01682837)
Timeframe: 4 weeks

Interventionng/ml (Mean)
Potassium Magnesium Citrate Powder Phase0.46
Potassium Citrate Powder Phase0.46
Potassium Chloride Powder Phase0.45
Placebo Phase0.49

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24-hour Average Diastolic Blood Pressure

The average diastolic blood pressure over a 24 hour period. (NCT01682837)
Timeframe: 4 weeks

InterventionmmHg (Mean)
Potassium Magnesium Citrate Powder Phase79
Potassium Citrate Powder Phase78
Potassium Chloride Powder Phase78
Placebo Phase80

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Central Aortic Systolic Blood Pressure

(NCT01682837)
Timeframe: 4 weeks

InterventionmmHg (Mean)
Potassium Magnesium Citrate Powder Phase121
Potassium Citrate Powder Phase125
Potassium Chloride Powder Phase123
Placebo Phase126

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Office Diastolic Blood Pressure

(NCT01682837)
Timeframe: 4 weeks

InterventionmmHg (Mean)
Potassium Magnesium Citrate Powder Phase81
Potassium Citrate Powder Phase81
Potassium Chloride Powder Phase80
Placebo Phase81

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Office Systolic Blood Pressure

(NCT01682837)
Timeframe: 4 weeks

InterventionmmHg (Mean)
Potassium Magnesium Citrate Powder Phase124
Potassium Citrate Powder Phase125
Potassium Chloride Powder Phase127
Placebo Phase129

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24-hour Average Systolic Blood Pressure

Systolic blood pressure was measured through an ambulatory blood pressure monitoring device worn by each participant for 24 hours after completing each treatment phase. This devise measures blood pressure intermittently throughout the day and night and provides the average of all readings. (NCT02653560)
Timeframe: 4 weeks

InterventionmmHg (Mean)
Potassium Magnesium Citrate (KMgCit) Arm127
Potassium Citrate Arm127
Potassium Chloride Arm126
Placebo129

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Chang in Hepatic Fat Measured at Baseline and Week 16

Will be measured using hepatic magnetic resonance imaging at baseline and at week 16 (NCT02665117)
Timeframe: baseline to week 16

Interventionpercent (Mean)
KMgCit + Chlorthalidone0.31
KCl + Chlorthalidone1.59

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Change in Fasting Plasma Glucose From Week 4 to Week 16

Fasting plasma glucose was measured from venous blood sample at week 4 and week 16 (NCT02665117)
Timeframe: week 4 and week 16

Interventionmg/dL (Mean)
KMgCit + Chlorthalidone-5.6
KCl + Chlorthalidone2.3

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Change in FGF23 From Week 4 to Week 16

Will be measured from venous blood sample from week 4 to week 16 (NCT02665117)
Timeframe: week 4 to week 16

Interventionpg/ml (Mean)
KMgCit + Chlorthalidone38.1
KCl + Chlorthalidone13.6

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Change in Muscle Magnesium Content Measured at Baseline and Week 16

Will be measured using magnetic resonance imaging at baseline and at week 16 (NCT02665117)
Timeframe: baseline to week 16

InterventionmM (Mean)
KMgCit + Chlorthalidone-0.01
KCl + Chlorthalidone0.02

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Efficacy of RMJH-111b Compared to Placebo Based on Change From Baseline in DBPnight After 7 Days of Treatment

"DBPnight = mean nighttime (10 PM to 6 AM) ABPM DBP. Note, mean values of change that are negative represent a decrease in that value from baseline, whereas values that are positive represent an increase.~DBPnight was measured twice during the subject's stay at the CRU: baseline measurements were collected from Day 3 to pre-dose Day 4 & post-dose measurements were collected from Day 10 to Day 11. An Investigational Site staff member placed the cuff on the subject's non-dominant arm & connected the ABPM at approximately 7 AM (± 60 minutes) on Days 3 & 10. A pre-dose ABPM reading was recorded immediately prior to the morning dose of run-in period placebo on Day 3 & the morning dose of treatment period Study Drug (active or placebo) on Day 10. The ABPM was started again immediately after dosing. The ABPM was removed at approximately 8 AM (± 60 minutes) on Days 4 and 11, respectively, but no sooner than 24 hours after the continuous monitoring was initiated." (NCT02822222)
Timeframe: 8 days

InterventionmmHg (Mean)
RMJH-111b-1.9
Placebo-0.6

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Efficacy of RMJH-111b Compared to Placebo Based on Change From Baseline in SBP24hr After 7 Days of Treatment

"SBP24hr = mean 24-hour ABPM SBP. Note, mean values of change that are negative represent a decrease in that value from baseline, whereas values that are positive represent an increase.~SBP24hr was measured twice during the subject's stay at the CRU: baseline measurements were collected from Day 3 to pre-dose Day 4 & post-dose measurements were collected from Day 10 to Day 11. An Investigational Site staff member placed the cuff on the subject's non-dominant arm & connected the ABPM at approximately 7 AM (± 60 minutes) on Days 3 & 10. A pre-dose ABPM reading was recorded immediately prior to the morning dose of run-in period placebo on Day 3 & the morning dose of treatment period Study Drug (active or placebo) on Day 10. The ABPM was started again immediately after dosing. The ABPM was removed at approximately 8 AM (± 60 minutes) on Days 4 and 11, respectively, but no sooner than 24 hours after the continuous monitoring was initiated." (NCT02822222)
Timeframe: 8 days

InterventionmmHg (Mean)
RMJH-111b-3.8
Placebo2.3

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Efficacy of RMJH-111b Compared to Placebo Based on Change From Baseline in SBPday After 7 Days of Treatment

"SBPday = mean daytime (8 AM to 4 PM) ABPM SBP. Note, mean values of change that are negative represent a decrease in that value from baseline, whereas values that are positive represent an increase.~SBPday was measured twice during the subject's stay at the CRU: baseline measurements were collected from Day 3 to pre-dose Day 4 & post-dose measurements were collected from Day 10 to Day 11. An Investigational Site staff member placed the cuff on the subject's non-dominant arm & connected the ABPM at approximately 7 AM (± 60 minutes) on Days 3 & 10. A pre-dose ABPM reading was recorded immediately prior to the morning dose of run-in period placebo on Day 3 & the morning dose of treatment period Study Drug (active or placebo) on Day 10. The ABPM was started again immediately after dosing. The ABPM was removed at approximately 8 AM (± 60 minutes) on Days 4 and 11, respectively, but no sooner than 24 hours after the continuous monitoring was initiated." (NCT02822222)
Timeframe: 8 days

InterventionmmHg (Mean)
RMJH-111b-4.6
Placebo1.6

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Efficacy of RMJH-111b Compared to Placebo Based on Change From Baseline in SBPnight After 7 Days of Treatment

"SBPnight = mean daytime (10 PM to 6 AM) ABPM SBP. Note, mean values of change that are negative represent a decrease in that value from baseline, whereas values that are positive represent an increase.~SBPnight was measured twice during the subject's stay at the CRU: baseline measurements were collected from Day 3 to pre-dose Day 4 & post-dose measurements were collected from Day 10 to Day 11. An Investigational Site staff member placed the cuff on the subject's non-dominant arm & connected the ABPM at approximately 7 AM (± 60 minutes) on Days 3 & 10. A pre-dose ABPM reading was recorded immediately prior to the morning dose of run-in period placebo on Day 3 & the morning dose of treatment period Study Drug (active or placebo) on Day 10. The ABPM was started again immediately after dosing. The ABPM was removed at approximately 8 AM (± 60 minutes) on Days 4 and 11, respectively, but no sooner than 24 hours after the continuous monitoring was initiated." (NCT02822222)
Timeframe: 8 days

InterventionmmHg (Mean)
RMJH-111b-4.2
Placebo0.7

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Efficacy of RMJH-111b Compared to Placebo Based on Change From Baseline in Seated DBP After 7 Days of Treatment

Change from baseline (pre-dose Day 4) in seated DBP after 7 days of treatment (Day 11) with RMJH-111b compared to placebo was a secondary efficacy variable (i.e., seated DBP served dual functions as safety and efficacy variables, with the safety population used for the safety analyses described in outcome 3 and the efficacy population used for the efficacy analyses described here). Note, mean values that are negative represent a decrease in that value from baseline, whereas values that are positive represent an increase. (NCT02822222)
Timeframe: 7 days

InterventionmmHg (Mean)
RMJH-111b-6.4
Placebo-2.3

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Efficacy of RMJH-111b Compared to Placebo Based on Change From Baseline in Seated SBP After 7 Days of Treatment

Change from baseline (pre-dose Day 4) in seated SBP after 7 days of treatment (Day 11) with RMJH-111b compared to placebo was a secondary efficacy variable (i.e., seated SBP served dual functions as safety and efficacy variables, with the safety population used for the safety analyses described in outcome 3 and the efficacy population used for the efficacy analyses described here). Note, mean values that are negative represent a decrease in that value from baseline, whereas values that are positive represent an increase. (NCT02822222)
Timeframe: 7 days

InterventionmmHg (Mean)
RMJH-111b-14.6
Placebo-7.2

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Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in 12-lead ECG Ventricular Rate (After Last Dose)

Change in mean 12-lead ECG ventricular rate from baseline (Screening or Day 1) to after the last randomized dose (Day 11). Mean values that are negative represent a decrease in that value from baseline, whereas values that are positive represent an increase. The ECG assessments were recorded after the subject was resting at least 5 minutes in the supine position in a quiet environment. (NCT02822222)
Timeframe: Up to 13 days

Interventionbpm (Mean)
RMJH-111b4.73
Placebo-3.83

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Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in 24-hour Urinary Magnesium Excretion

Change in the mean value of 24-hour urinary magnesium excretion from baseline (Day 3 to pre-dose Day 4) to end of treatment (Day 10 to Day 11). Mean values that are negative represent a decrease in that value from baseline, whereas values that are positive represent an increase. (NCT02822222)
Timeframe: 8 days

InterventionmEq/24 hours (Mean)
RMJH-111b9.1
Placebo-1.3

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Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in Body Weight

Change in mean body weight from baseline (Day 1) to end of treatment (Day 11). The weight measurements were made using a calibrated scale with the subject wearing light clothes and no shoes. Mean values that are negative represent a decrease in that value from baseline, whereas values that are positive represent an increase. (NCT02822222)
Timeframe: 10 days

Interventionkg (Mean)
RMJH-111b-1.09
Placebo-0.79

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Pharmacokinetics of Total Serum Magnesium After Single and Repeated Oral Administrations of RMJH-111b Compared to Placebo Based on AUC

"Venous blood samples were collected within 1 hour prior to & 0.5, 1, 2, 3, 6, & 12 hours following the morning dose of Study Drug on Days 3 (run-in placebo) and 4, & within 1 hour prior to & 0.5, 1, 2, 3, 6, 12, & 24 hours following the morning dose of Study Drug on Day 10. Blood samples were processed to serum & assayed for total serum magnesium by a central laboratory. The LLOQ was 0.06 mEq/L.~Individual PK parameters for Days 4 & 10 were to be calculated using corrected concentration-time curves (with individual's baseline assessments of endogenous total serum magnesium at Day 3 subtracted); however, due to small numerical values after correction, the planned PK parameters could not be derived. The analyses were reattempted using the observed values (that include the endogenous levels of magnesium), which allowed AUC0-24 to be derived." (NCT02822222)
Timeframe: 8 days

,
InterventionmEq*24hr/L (Mean)
Day 3 (pre-dose)Day 4 (1st day of dosing)Day 10 (7th day of dosing)
Placebo42.842.441.7
RMJH-111b41.443.943.9

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Pharmacokinetics of Total Serum Magnesium After Single and Repeated Oral Administrations of RMJH-111b Compared to Placebo Based on Trough Concentration Ratio

"Venous blood samples were collected within 1 hour prior to the morning dose of Study Drug (active or placebo) on Days 4, 5, 6, 7, 8, 9, and 10. Blood samples were processed to serum & assayed for total serum magnesium by a central laboratory (LLOQ = 0.06 mEq/L).~Ratios of the individual total serum magnesium trough concentrations at Days 5, 6, 7, 8, 9, and 10 relative to baseline (pre-dose Day 4) were calculated. Observed concentrations (including the endogenous levels of magnesium) were used for this purpose." (NCT02822222)
Timeframe: 6 days

,
Interventionunitless (i.e., ratio of mEq/L to mEq/L) (Mean)
Day 5/Day 4 trough concentrationsDay 6/Day 4 trough concentrationsDay 7/Day 4 trough concentrationsDay 8/Day 4 trough concentrationsDay 9/Day 4 trough concentrationsDay 10/Day 4 trough concentrations
Placebo1.000.990.981.011.020.96
RMJH-111b1.091.101.081.091.061.02

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Pharmacokinetics of Urine Magnesium After Single and Repeated Oral Administrations of RMJH-111b Compared to Placebo Based on 24-hour Urinary Excretion

"Urinary excretion of magnesium was assessed over three 24-hour periods. The first urine collection started immediately after the morning dose of run-in placebo on Day 3, and the second and third collections started immediately after the morning dose of Study Drug on Days 4 and 10, respectively.~Observed 24-hour urinary magnesium excretion values at Days 3, 4, and 10 (i.e., without subtraction of the Day 3 values to correct for the individual's baseline assessment of endogenous urinary magnesium excretion) were used for comparisons with the total serum magnesium data (as only the observed serum values allowed for PK parameter derivation)." (NCT02822222)
Timeframe: 8 days

,
InterventionmEq/24 hrs (Mean)
Day 3 (pre-dose)Day 4 (1st day of dosing)Day 10 (7th day of dosing)
Placebo7.05.75.7
RMJH-111b7.39.816.5

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Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in 12-lead ECG Diagnosis (3 Hours After 1st Dose)

Change in 12-lead ECG diagnosis [i.e., normal to abnormal not clinically significant (NCS); normal to abnormal clinically significant (CS); abnormal NCS to abnormal CS; remained abnormal NCS; remained normal] from baseline (Screening or Day 1) to 3 hours after the first randomized dose (Day 4). The ECG was recorded after the subject was resting at least 5 minutes in the supine position in a quiet environment. (NCT02822222)
Timeframe: Up to 6 days

,
InterventionParticipants (Count of Participants)
Changed from Normal to Abnormal NCSChanged from Normal to Abnormal CSChanged from Abnormal NCS to Abnormal CSRemained Abnormal NCSRemained Normal
Placebo10032
RMJH-111b10078

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Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in 12-lead ECG Diagnosis (After Last Dose)

Change in 12-lead ECG diagnosis [i.e., normal to abnormal not clinically significant (NCS); normal to abnormal clinically significant (CS); abnormal NCS to abnormal CS; remained abnormal NCS; remained normal] from baseline (Screening or Day 1) to after the last randomized dose (Day 11). The ECG was recorded after the subject was resting at least 5 minutes in the supine position in a quiet environment. (NCT02822222)
Timeframe: Up to 13 days

,
InterventionParticipants (Count of Participants)
Changed from Normal to Abnormal NCSChanged from Normal to Abnormal CSChanged from Abnormal NCS to Abnormal CSRemained Abnormal NCSRemained NormalChanged from Abnormal NCS to Normal
Placebo000231
RMJH-111b100671

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Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in 12-lead ECG Intervals (3 Hours After 1st Dose)

Change in mean 12-lead ECG intervals (RR interval, PR interval, QRS interval, QT interval, corrected QT interval based on Fridericia formula) from baseline (Screening or Day 1) to 3 hours after the first randomized dose (Day 4). Mean values that are negative represent a decrease in that value from baseline, whereas values that are positive represent an increase. The ECG assessments were recorded after the subject was resting at least 5 minutes in the supine position in a quiet environment. (NCT02822222)
Timeframe: Up to 6 days

,
Interventionmsec (Mean)
Change in RR IntervalChange in PR IntervalChange in QRS IntervalChange in QT IntervalChange in Corrected QT Interval
Placebo55.338.672.33-0.33-9.17
RMJH-111b8.060.75-2.63-5.06-5.06

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Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in 12-lead ECG Intervals (After Last Dose)

Change in mean 12-lead ECG intervals (RR interval, PR interval, QRS interval, QT interval, corrected QT interval based on Fridericia formula) from baseline (Screening or Day 1) to after the last randomized dose (Day 11). Mean values that are negative represent a decrease in that value from baseline, whereas values that are positive represent an increase. The ECG assessments were recorded after the subject was resting at least 5 minutes in the supine position in a quiet environment. (NCT02822222)
Timeframe: Up to 13 days

,
Interventionmsec (Mean)
Change in RR IntervalChange in PR IntervalChange in QRS IntervalChange in QT IntervalChange in Corrected QT Interval
Placebo29.678.33-0.675.67-0.33
RMJH-111b-57.00-4.00-1.33-11.67-1.47

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Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in Patellar Reflex Score

"Changes in patellar reflex score from baseline (pre-dose Day 4) to interim time points during the randomized treatment period (prior to each morning dose on Days 5 through 10) and to post-dose time points (Day 11 & Day 18 ± 3 days). The scoring values included 0, 1+, 2+, 3+, and 4+, where 2+ means normal patellar reflex and lower scores indicate a worsened outcome (1+ means reflex present only with reinforcement and 0 means loss of reflex). The patellar reflex assessment was made with the subject in the seated position, with legs hanging freely from the exam table.~Loss of patellar reflex is an early sign of magnesium toxicity, and thus the test serves as an assessment for functional magnesium status. A clinical indication of a safe magnesium dosage regimen included the presence of the patellar reflex (knee jerk)." (NCT02822222)
Timeframe: 14 days +/- 3 days

,
InterventionParticipants (Count of Participants)
Remained at 2+Remained at 1+Remained at 2+ except Day 9 (1+)Remained at 1+ except Day 5 & 8 (2+)Remained at 1+ except Day 18 (2+)Remained 1+ except Days 6, 10, & 11 (2+)
Placebo600000
RMJH-111b921111

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Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in Seated SBP and DBP

Changes in the mean values for seated SBP & DBP from baseline (pre-dose Day 4) to end of treatment (Day 11). Mean values that are negative represent a decrease in that value from baseline, whereas values that are positive represent an increase. (NCT02822222)
Timeframe: 7 days

,
InterventionmmHg (Mean)
Change in seated SBPChange in seated DBP
Placebo-7.2-2.3
RMJH-111b-14.6-6.4

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Safety and Tolerability of RMJH-111b Compared to Placebo Based on Treatment Emergent Adverse Events (TEAEs)

"Safety & tolerability were primarily assessed based on the incidence of reported TEAEs by system organ class & preferred term, as well as by categories: TEAE, severe TEAE, serious TEAE, drug-related TEAE, drug-related severe TEAE, drug-related serious TEAE, TEAE leading to discontinuation, & TEAE with outcome of death. Drug-related TEAEs were defined as TEAEs assigned a Study Drug (active or placebo) relationship of adverse reaction or suspected adverse reaction.~TEAEs were coded using the Medical Dictionary for Regulatory Activities, version 19.0. The severity of TEAEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. TEAEs were defined as any adverse event that started or increased in severity after the first randomized dose of Study Drug on Day 4 through the Final Study Visit (8 +/-3 days after last randomized dose)." (NCT02822222)
Timeframe: 14 days +/- 3 days

,
InterventionParticipants (Count of Participants)
TEAESevere TEAESerious TEAEDrug-related TEAEDrug-related severe TEAEDrug-related serious TEAETEAE leading to discontinuation from studyTEAE with outcome of deathMild abdominal pain upperModerate constipationMild diarrhoeaMild flatulenceMild headacheMild cough
Placebo10000000000010
RMJH-111b50020000112112

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Safety and Tolerability of RMJH-111b Compared to Placebo Based on Change in 12-lead ECG Ventricular Rate (3 Hours After 1st Dose)

Change in mean 12-lead ECG ventricular rate from baseline (Screening or Day 1) to 3 hours after the first randomized dose (Day 4). Mean values that are negative represent a decrease in that value from baseline, whereas values that are positive represent an increase. The ECG assessments were recorded after the subject was resting at least 5 minutes in the supine position in a quiet environment. (NCT02822222)
Timeframe: Up to 6 days

Interventionbpm (Mean)
RMJH-111b-0.31
Placebo-5.17

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Efficacy of RMJH-111b Compared to Placebo Based on Change From Baseline in DBP24hr After 7 Days of Treatment

"DBP24hr = mean 24-hour ABPM DBP. Note, mean values of change that are negative represent a decrease in that value from baseline, whereas values that are positive represent an increase.~DBP24hr was measured twice during the subject's stay at the CRU: baseline measurements were collected from Day 3 to pre-dose Day 4 & post-dose measurements were collected from Day 10 to Day 11. An Investigational Site staff member placed the cuff on the subject's non-dominant arm & connected the ABPM at approximately 7 AM (± 60 minutes) on Days 3 & 10. A pre-dose ABPM reading was recorded immediately prior to the morning dose of run-in period placebo on Day 3 & the morning dose of treatment period Study Drug (active or placebo) on Day 10. The ABPM was started again immediately after dosing. The ABPM was removed at approximately 8 AM (± 60 minutes) on Days 4 and 11, respectively, but no sooner than 24 hours after the continuous monitoring was initiated." (NCT02822222)
Timeframe: 8 days

InterventionmmHg (Mean)
RMJH-111b-2.3
Placebo0.3

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Efficacy of RMJH-111b Compared to Placebo Based on Change From Baseline in DBPday After 7 Days of Treatment

"DBPday = mean daytime (8 AM to 4 PM) ABPM DBP. Note, mean values of change that are negative represent a decrease in that value from baseline, whereas values that are positive represent an increase.~DBPday was measured twice during the subject's stay at the CRU: baseline measurements were collected from Day 3 to pre-dose Day 4 & post-dose measurements were collected from Day 10 to Day 11. An Investigational Site staff member placed the cuff on the subject's non-dominant arm & connected the ABPM at approximately 7 AM (± 60 minutes) on Days 3 & 10. A pre-dose ABPM reading was recorded immediately prior to the morning dose of run-in period placebo on Day 3 & the morning dose of treatment period Study Drug (active or placebo) on Day 10. The ABPM was started again immediately after dosing. The ABPM was removed at approximately 8 AM (± 60 minutes) on Days 4 and 11, respectively, but no sooner than 24 hours after the continuous monitoring was initiated." (NCT02822222)
Timeframe: 8 days

InterventionmmHg (Mean)
RMJH-111b-3.5
Placebo-1.2

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Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2)

Tolerance of Bowel Preparation Assessed by VAS score 1+2 ( 1-excellent, 5-very poor) (NCT02956057)
Timeframe: One day

InterventionParticipants (Count of Participants)
PEG1D56
PEG2D72
SPMC1D134
SPMC2D139
PEGA1D85
PEGA2D80

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Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2)

Bowel preparation score 1+2 expressed on Aronchick scale (1 the best, 5 the worst) (NCT02956057)
Timeframe: One day

InterventionParticipants (Count of Participants)
PEG1D110
PEG2D145
SPMC1D100
SPMC2D134
PEGA1D121
PEGA2D55

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Average Daily Opioid Requirement [in IV Fentanyl Equivalents (mcg Per Day)]

Average daily opioid requirement is converted to IV fentanyl equivalent listed in mcg per day (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

Interventionmcg per day (Mean)
Naloxegol Oral Tablet1420
Placebo Oral Tablet1600

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Daily Difference in the Pre-dose and Post-dose Clinical Opioid Withdrawal Scale (COWS) Score

Patients were evaluated 1 hour before and 2 hours after the administration of each dose of study medication using the Clinical Opioid Withdrawal Scale (COWS). COWS is used to help determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids. The COWS score ranges from 0-36+. A score of 0 is no active opioid withdrawal. A score of 5-12 is mild; 13-24 is moderate; 25-36 is moderately severe and more than 36 is severe opioid withdrawal. (NCT02977286)
Timeframe: One hour before the daily study drug administration and 2 hours after the daily study drug administration

InterventionDifference of COWS score (Mean)
Naloxegol Oral Tablet-0.1
Placebo Oral Tablet0.2

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Daily Fluid Balance

Daily fluid balance measured in mL is the 24 hours ins and outs (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

InterventionmL (Mean)
Naloxegol Oral Tablet-338
Placebo Oral Tablet-210

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Daily Maximal Pain Scale Score

"Based on the highest daily Visual Analogue Scale-10 or Clinical Pain Observation tool assessment.~VAS-10 is Visual Analogue Scale which uses a nurse-administered 10 point rating scale. A measurement of 0-1 is minimal pain. A measurement of 10 is severe pain." (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

Interventionscore on a scale (Mean)
Naloxegol Oral Tablet0
Placebo Oral Tablet0

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Daily Maximal Sedation Assessment Scale (SAS) Score

"The Sedation Assessment Scale is rated 1 to 7. Score of 7 is dangerous agitation. Score of 1 is unarousable. Score of 2 is very sedated. The presence of coma is based on the every 4 hour sedation agitation score scale (SAS) assessment. A score of 1 or 2 any time during the day represents that a coma is present. A score of 3-7 represents a subject with no coma present.~Results listed here is days without coma (SAS score of 3-7)" (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

Interventiondays (Median)
Naloxegol Oral Tablet3
Placebo Oral Tablet7

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Daily Presence of Delirium Using the Intensive Care Delirium Screening Checklist (ICDSC)

Measures as days without delirium with daily presence of delirium assessed using the Intensive Care Delirium Screening Checklist (ICDSC) (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

Interventiondays without delirium (Median)
Naloxegol Oral Tablet5
Placebo Oral Tablet6

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Days Without Mechanical Ventilation Support for Duration of ICU Stay

Measure is days without mechanical ventilation for duration of ICU stay as expressed as median and inter-Quartile Range (NCT02977286)
Timeframe: From ICU admission to ICU discharge or a maximum of 10 ICU days

Interventiondays (Median)
Naloxegol Oral Tablet0.5
Placebo Oral Tablet1

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ICU Days Without a SBM

Measured ICU days that subjects did not have a SBM (NCT02977286)
Timeframe: During period of ICU admission or a maximum of 10 ICU days

InterventionDays (Mean)
Naloxegol Oral Tablet2
Placebo Oral Tablet2

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Number of Patients With Loose and Unformed or Liquid SBM

Consistency of SBM is characterized in one of 4 categories: hard and formed, soft but formed, loose and unformed, and liquid. The number listed in the results section is the number of patients who had either loose or liquid SBM (as opposed to hard or soft formed). (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

InterventionParticipants (Count of Participants)
Naloxegol Oral Tablet5
Placebo Oral Tablet6

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Occurrence of Lower GI Tract Paralysis (≥3 Days Without a SBM)

Measurement is the number of subjects in each group having this occurrence of lower GI tract paralysis during time frame (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

InterventionParticipants (Count of Participants)
Naloxegol Oral Tablet2
Placebo Oral Tablet3

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Occurrence of Lower GI Tract Paralysis Requiring GI/Surgical Consultation

Number of patients with GI tract paralysis requiring Gastroenterology service or Surgical service consultation (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

InterventionParticipants (Count of Participants)
Naloxegol Oral Tablet0
Placebo Oral Tablet0

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Percentage of Daily Goal Reached for Enteral Nutrition Administration

Enteral nutrition is assessed as daily volume in mL and the reported measure is the percentage of daily goal of enteral nutrition met. (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

Interventionpercentage of daily goals met (Mean)
Naloxegol Oral Tablet54
Placebo Oral Tablet51

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Time to First Episode of Diarrhea

The number of patients in each group with > or equal to 1 episode of diarrhea after initiation of study drug. The time to first episode of diarrhea was measured in hours. (NCT02977286)
Timeframe: Study drug initiation to first episode of diarrhea in hours.

Interventionhours (Median)
Naloxegol Oral Tablet40
Placebo Oral Tablet109

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Time to First Spontaneous Bowel Movement (SBM)

Time to first spontaneous bowel movement during the ICU admission after opioid initiation (NCT02977286)
Timeframe: First occurrence after initiation of IV opioid therapy during period of ICU admission or a maximum of 10 ICU days

Interventionhours (Mean)
Naloxegol Oral Tablet52
Placebo Oral Tablet49

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Time to First Spontaneous Bowel Movement (SBM) Administration

Time to first spontaneous bowel movement during ICU admission after randomization (NCT02977286)
Timeframe: First occurrence after study randomization during period of ICU admission or a maximum of 10 ICU days

Interventionhours (Mean)
Naloxegol Oral Tablet41
Placebo Oral Tablet33

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Abdominal Pressure Measurement

On days when the patient had a urinary catheter in place for clinical reasons, a bladder pressure transducer was inserted and abdominal pressure was measured. The average daily maximum pressure score for each group is reported. (NCT02977286)
Timeframe: From randomization to ICU discharge (or removal of foley catheter) or a maximum of 10 ICU days

InterventionmmHg (Mean)
Naloxegol Oral Tablet10
Placebo Oral Tablet13

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Number of Patients That Required Use of the Study Laxative Protocol

A 4-step laxative protocol was initiated when there was no spontaneous bowel movement greater than or equal to 3 days time. Data collected on study laxative protocol included any use as well as the highest level needed. (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

Interventionparticipants (Number)
Naloxegol Oral Tablet5
Placebo Oral Tablet4

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Change From Baseline in the Fractional Excretion of Magnesium (FEMg) at 2 Years

Change from baseline in the fractional excretion of magnesium (FEMg) at 2 years as measured by the ratio of magnesium clearance and creatinine clearance, using 24-h urinary magnesium and creatinine and corresponding serum magnesium and creatinine obtained post meal/load. (NCT03812380)
Timeframe: Baseline and 2 years

Interventionpercentage (Number)
Placebo-1.0

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Change From Baseline in Urine Magnesium at 2 Years

Change from baseline in urine magnesium at 2 years was measured by by atomic absorption. (NCT03812380)
Timeframe: Baseline and 2 years

Interventionmg/day (Number)
Placebo-8

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Change From Baseline in Bone Mineral Density (BMD) T-Score at 2 Years

Change from baseline in bone mineral density (BMD) T-Score at 2 years as measured by dual photon absorptiometry. The range, as defined by the World Health Organization (WHO), for T-Score is: -1 and above = Normal, Between -1 and -2.5 = Osteopenia, -2.5 and below = osteoporosis. (NCT03812380)
Timeframe: Baseline and 2 years

InterventionT-Score (Number)
L2-L4 T-ScoreFemoral Neck T-ScoreTotal Hip T-ScoreRadial 1/3rd T-Score
Placebo-0.4-1.0-0.7-0.3

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Change From Baseline in Bone Mineral Density (BMD) Z-Score at 2 Years

Change from baseline in bone mineral density (BMD) Z-score at 2 years as measured by dual photon absorptiometry. Outcome is considered positive if the Z Score after two years of treatment becomes less negative (less than -2). There is no specific score range for the Z Score. (NCT03812380)
Timeframe: Baseline and 2 years

InterventionZ-Score (Number)
L2L4 Z-ScoreFemoral Neck Z-ScoreTotal Hip Z-ScoreRadial 1/3rd Z-Score
Placebo-0.1-0.8-0.7-0.1

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Change From Baseline in Serum Bicarbonate at 2 Years

Change from baseline in serum bicarbonate at 2 years will be measured to see improvement in acid based status in lowering kidney function impairment. (NCT03812380)
Timeframe: Baseline and 2 years

Interventionmmol/L (Number)
Placebo-2

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Change From Baseline in Free Muscle Magnesium at 2 Years

Change From baseline in free muscle magnesium at 2 years as assessed by measuring intracellular Mg in a calf muscle, by using 31P (Phosphorous) magnetic resonance spectroscopy (MRS). (NCT03812380)
Timeframe: Baseline and 2 years

Interventionmmol/L (Number)
Placebo-0.044

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Change From Baseline in Serum Bone Resorption Marker C-terminal Telopeptide (CTX) at 2 Years

Change from baseline in serum bone resorption marker C-terminal telopeptide (CTX) at 2 years will be measured by lab finding utilizing ELISA CTX-I (CrossLaps). (NCT03812380)
Timeframe: Baseline and 2 years

Interventionng/ml (Number)
Placebo0.15

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Change From Baseline in Endogenous Creatinine Clearance at 2 Years

Change from baseline in endogenous creatinine clearance at 2 years will be measured. Endogenous creatinine clearance will be obtained by using 24-h urinary creatinine and post-meal/load venous blood sample ((uCr, mg/24hr) / (sCr,mg/dL * 14.4)) (NCT03812380)
Timeframe: Baseline and 2 years

Interventionml/min (Number)
Placebo13

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Change From Baseline in Serum Magnesium at 2 Years

Change from baseline in serum magnesium at 2 years will be measured by ion selective electrode. (NCT03812380)
Timeframe: Baseline and 2 years

Interventionmg/dL (Number)
Placebo0.2

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Change From Baseline in Serum Parathyroid Function (PTH) at 2 Years

Change from baseline in serum parathyroid function (PTH) at 2 years will be measured by Biomerica Intact-PTH ELISA. (NCT03812380)
Timeframe: Baseline and 2 years

Interventionpg/ml (Number)
Placebo75

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COVID Ordinal Outcome Scale

"Outcome measured clinical status of the participant defined by the COVID Ordinal Outcome Scale on Day 7:~0 = Uninfected, no viral RNA detected~= Asymptomatic, viral RNA detected~= Symptomatic, independent~= Symptomatic, assistance needed~= Hospitalized, no oxygen needed~= Hospitalized, oxygen by mask or nasal prongs~= Hospitalized, oxygen by NIV or high flow~= Intubation and mechanical ventilation, pO2/FiO2 ≥150 or SpO2/FiO2 ≥200~= Mechanical ventilation, pO2/FiO2 <150 (SpO2/FiO2 <200) or vasopressors~= Mechanical ventilation, pO2/FiO2 <150 and vasopressors, dialysis or ECMO~= Dead" (NCT04941703)
Timeframe: Baseline through Day 7 after completion of therapy

,
InterventionParticipants (Count of Participants)
Outcome Score = 0Outcome Score = 1Outcome Score = 2Outcome Score = 3Outcome Score = 4Outcome Score = 5Outcome Score = 6Outcome Score = 7Outcome Score = 8Outcome Score = 9Outcome Score = 10
Magnesium Citrate Plus a Probiotic Arm:00120120000
Placebo00110140000

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Change in Oxygen Requirements From Baseline to Day 7 by Treatment Group

Measured by liters of oxygen per minute to maintain saturation above 90% (NCT04941703)
Timeframe: baseline and 7 days

Interventionliters per minute (Median)
Magnesium Citrate Plus a Probiotic Arm:2.00
Placebo9.00

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