Page last updated: 2024-12-11

simethicone

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

Description

Simethicone: A poly(dimethylsiloxane) which is a polymer of 200-350 units of dimethylsiloxane, along with added silica gel. It is used as an antiflatulent, surfactant, and ointment base. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID6433516
SCHEMBL ID339371
MeSH IDM0019885

Synonyms (8)

Synonym
simethicone
8050-81-5
simeticone
FT-0674588
SCHEMBL339371
dioxosilane;methoxy-dimethyl-trimethylsilyloxysilane
Q419415
DB09512

Research Excerpts

Overview

Simethicone is a common antifoaming agent that is added to endoscopic rinse solutions, but data regarding its effect on polyp detection rates is lacking. Simethicone has been implicated as a risk factor for transmission of infections due to the formation of simethicone deposits within scope channels.

ExcerptReferenceRelevance
"Simethicone is an adjunct frequently used during bowel preparation before colonoscopy and currently there is no consensus on whether it should be recommended in standard bowel preparation. "( Simethicone decreases bloating and improves bowel preparation effectiveness: a systematic review and meta-analysis.
Dang, JT; Dang, TNT; Karmali, S; Moolla, M; Shaw, A; Sultanian, R; Tian, C, 2019
)
3.4
"Simethicone (SIM) is a commonly used antifoaming agent in the clinic. "( The Efficacy of Simethicone With Polyethylene Glycol for Bowel Preparation: A Systematic Review and Meta-Analysis.
Fei, S; Li, Z; Liu, X; Yuan, M; Zhao, G, 2021
)
2.41
"Simethicone is a common antifoaming agent that is added to endoscopic rinse solutions, but data regarding its effect on polyp detection rates is lacking. "( Influence of Simethicone Added to the Rinse Water during Colonoscopies on Polyp Detection Rates: Results of an Unintended Cohort Study.
Gould, K; Gururatsakul, M; Gurusamy, SR; Holtmann, GJ; Hourigan, L; Kendall, BJ; Kutyla, M; O'Connor, S; Whaley, A, 2018
)
2.29
"Simethicone is an anti-foaming agent commonly used during colonoscopy. "( The benefit of adding oral simethicone in bowel preparation regimen for the detection of colon adenoma: A systematic review and meta-analysis.
Chen, TH; Hsu, MH; Huang, RY; Lee, CT; Lin, CW; Tseng, CM; Wang, WL; Yeh, JH, 2019
)
2.25
"Simethicone is an antifoaming agent frequently added to endoscopic rinse solutions but has recently been implicated as a risk factor for transmission of infections due to the formation of simethicone deposits within scope channels. "( An in vitro and clinical dose-finding study of antifoaming effects of simethicone during colonoscopy.
Elson, J; Holtmann, GJ; Hourigan, LF; Kutyla, MJ; Meeusen, V; O'Connor, S; Shah, A, 2019
)
2.19
"Simethicone is an inert antifoaming able to reduce bloating, abdominal discomfort. "( A randomized double-blind placebo-controlled clinical trial on efficacy and safety of association of simethicone and Bacillus coagulans (Colinox®) in patients with irritable bowel syndrome.
Casale, C; de Vitis, I; Pistelli, R; Rapaccini, GL; Urgesi, R, 2014
)
2.06
"Simethicone is a well-known emulsifying agent that has been used to improve ultrasonographic visualization."( Factors Predictive of Improved Abdominal Ultrasound Visualization after Oral Administration of Simethicone.
Biagini, MR; Casseri, T; Gabbani, T; Marsico, M, 2016
)
1.37
"Simethicone is an inert, hydrophobic substance that may reduce reprocessing effectiveness."( Simethicone residue remains inside gastrointestinal endoscopes despite reprocessing.
Heymann, OL; Johnson, EA; Maust, TJ; Ofstead, CL; Shaw, MJ; Wetzler, HP, 2016
)
2.6
"Simethicone is a safe and inexpensive medication that may provide anesthesiologists with an effective treatment choice for suspected postoperative abdominal discomfort in infants."( Evaluation of simethicone for the treatment of postoperative abdominal discomfort in infants.
Burke, C; D'Agostino, R; Hadden, SM; Malviya, S; Siewert, M; Tait, AR; Voepel-Lewis, TD, 1998
)
2.1
"Simethicone, which is a principal ingredient in the defoaming agent used during gastroscopy, can inhibit the growth of Helicobacter pylori (MIC, 64-128 mg/l). "( Effect of simethicone on the accuracy of the rapid urease test.
Chow, SL; Kng, C; Lai, KC; Ng, FH; Ng, WF; Wong, SY, 1998
)
2.15

Actions

ExcerptReferenceRelevance
"Simethicone is used to enhance visualization during colonoscopy."( Optimal Timing of Simethicone Addition for Bowel Preparation Using Polyethylene Glycol Plus Ascorbic Acid.
Goong, HJ; Jeon, SR; Jung, YH; Kim, H; Kim, HG; Ko, BM; Lee, MS, 2019
)
1.57

Treatment

ExcerptReferenceRelevance
"Treatment with simethicone and placebo in double blind crossover fashion."( Simethicone in the treatment of infant colic: a randomized, placebo-controlled, multicenter trial.
Irons, TG; Metcalf, TJ; Sher, LD; Young, PC, 1994
)
2.08

Toxicity

ExcerptReferenceRelevance
" In acute and chronic experiments on 5 species of laboratory animals it was shown that polymethylsiloxane had no general toxic action on the animals, no damaging action on their internal organs, did not affect their functions and the state of the biological fluids, had no pyrogenic or allergenic effect."( [Study of general toxic properties and side effects of polymethylsiloxane and gentamicin immobilized on it].
Cherviak, PI; Kaban, AP; Keĭsevich, LV; Samodumova, IM; Znamenskiĭ, VA, 1988
)
0.27
"Of the 14 adverse events in 11 patients, only five, which included mild diarrhea and nausea, were considered related to the contrast agent."( Safety and efficacy of a new oral contrast agent for sonography: a phase II trial.
Barone, AE; Chong, WK; Goldberg, BB; Langer, JE; Lev-Toaff, AS; Rubin, DL; Zelch, JV, 1999
)
0.3
"SonoRx is a safe and well-tolerated contrast agent that improves the sonographic evaluation of the upper abdomen, with significant improvement in imaging the stomach, duodenum, and pancreas."( Safety and efficacy of a new oral contrast agent for sonography: a phase II trial.
Barone, AE; Chong, WK; Goldberg, BB; Langer, JE; Lev-Toaff, AS; Rubin, DL; Zelch, JV, 1999
)
0.3
" Dimethicone, Methicone, and Vinyldimethicone were not acutely toxic following oral exposure."( Final report on the safety assessment of stearoxy dimethicone, dimethicone, methicone, amino bispropyl dimethicone, aminopropyl dimethicone, amodimethicone, amodimethicone hydroxystearate, behenoxy dimethicone, C24-28 alkyl methicone, C30-45 alkyl methico
Nair, B, 2003
)
0.32

Pharmacokinetics

ExcerptReferenceRelevance
" Pharmacodynamic parameters were measured for 96 hours."( [Effect of dimethicone on pharmacokinetics and pharmacodynamics of ethyl biscoumacetate].
Chanteclair, G; Copie, X; de Lauture, D; Letrait, M; Olive, G; Paltiat, MH; Pello, JY; Pinquier, JL; Rey, E; Strauch, G,
)
0.13
" The kinetic parameters measured were area under the concentration (AUC), maximum peak plasma concentration (Cmax), time to reach peak concentration (tmax), elimination half-life (t1/2), mean residence time (MRT) and urinary excretion for R and S enantiomers."( Effect of dimethicone (polysilane gel) on the stereoselective pharmacokinetics of ketoprofen.
Bannwarth, B; Gillet, P; Herrmann, MA; Lapicque, F; Netter, P; Presle, N, 1998
)
0.3
"Dimethicone reduced the peak concentration of both R and S ketoprofen by about 10% (P<0."( Effect of dimethicone (polysilane gel) on the stereoselective pharmacokinetics of ketoprofen.
Bannwarth, B; Gillet, P; Herrmann, MA; Lapicque, F; Netter, P; Presle, N, 1998
)
0.3
" As a part of the fixed-dose combination registration process in Mexico, a pharmacokinetic and relative bioavailability study was carried out to demonstrate nonexistence of pharmacokinetic interaction when mosapride is administered alone or in combination with pancreatin and simethicone using DOSIER® (mosapride) 5-mg tablets as a reference product."( Relative bioavailability and pharmacokinetic comparison of a fixed-dose combination tablet of mosapride, pancreatin, and simethicone relative to single-component mosapride tablets in healthy Mexican subjects.
Argüelles Tello, FA; Camarillo Cárdenas, KP; García González, J; Moreno Hernández, JB; Ocampo Ramírez, JA; Pendela, MM, 2022
)
1.11

Compound-Compound Interactions

Purgative bowel cleansing combined with simethicone before CE improved the quality of imaging of the entire small bowel as well as the visualization of the mucosa in the proximal and distal small intestine. Three days fasting and oral senna, combined with 20% mannitol and simeth silicone, can reduce the effects of bile on the small bowel.

ExcerptReferenceRelevance
" These parameters were somewhat higher when ceftibuten was administered with ranitidine, but they were still within the ranges seen in normal healthy volunteers."( Pharmacokinetic drug interaction study: administration of ceftibuten concurrently with the antacid mylanta double- strength liquid or with ranitidine.
Affrime, M; Cutler, D; Lin, CC; Nomeir, A; Radwanski, E, 1998
)
0.3
"Ninety patients referred for CE were prospectively randomized to three equal groups according to the preparation used: (a) a control group, in which patients were requested to drink 1 L of clear liquids only, 12 h before the examination; (b) a purgative group, in which patients were requested to ingest 1 L of a polyethylene glycol (PEG)/electrolyte solution only, 12 h before the examination; or (c) a purgative combined with simethicone group (P-S group), in which patients were requested to ingest 1 L of PEG, 12 h before the examination, and 300 mg of simethicone, 20 min before the examination."( Purgative bowel cleansing combined with simethicone improves capsule endoscopy imaging.
Gao, YJ; Ge, ZZ; Hu, YB; Lu, H; Wei, W; Xiao, SD, 2008
)
0.78
"Purgative bowel cleansing combined with simethicone before CE improved the quality of imaging of the entire small bowel as well as the visualization of the mucosa in the proximal and distal small intestine."( Purgative bowel cleansing combined with simethicone improves capsule endoscopy imaging.
Gao, YJ; Ge, ZZ; Hu, YB; Lu, H; Wei, W; Xiao, SD, 2008
)
0.88
"Three days fasting and oral senna, combined with 20% mannitol and simethicone, before CE, can reduce the effects of bile on the small bowel and improve small bowel cleansing, especially in the distal small intestine."( Randomized controlled trial of 3 days fasting and oral senna, combined with mannitol and simethicone, before capsule endoscopy.
Chen, HB; Chun, H; Lian-Xiang, P; Rong-Pang, L; Shu-Ping, X; Xiao-Lin, L; Xiao-Zong, W; Yue, H, 2017
)
0.91

Bioavailability

ExcerptReferenceRelevance
"The aim of the study was to compare the bioavailability of progesterone dissolved in almond oil or dimethicone, and administered by nasal spray."( Progesterone administration by nasal spray in menopausal women: comparison between two different spray formulations.
Cagnazzo, I; Cicinelli, E; Galantino, P; Savino, F; Scorcia, P, 1992
)
0.28
" The bioavailability of cimetidine was not significantly affected by metoclopramide and it was marginally reduced by the antacid."( Effects on cimetidine bioavailability of metoclopramide and antacids given two hours apart.
Barzaghi, N; Crema, F; Mescoli, G; Perucca, E, 1989
)
0.28
"The effect of two antacids on the bioavailability of paracetamol has been investigated in 12 young healthy volunteers."( Effect of two antacids on the bioavailability of paracetamol.
Albin, H; Bedjaoui, A; Begaud, B; Demotes-Mainard, F; Vinçon, G, 1985
)
0.27
"To investigate the effect of antacid on the bioavailability and disposition of ranitidine six healthy volunteers were studied on two occasions one week apart."( High dose of antacid (Mylanta II) reduces bioavailability of ranitidine.
Jones, DB; Louis, WJ; Marino, AT; Mihaly, GW; Smallwood, RA; Webster, LK, 1982
)
0.26
" 2 The bioavailability of phenytoin when given concomitantly with Asilone was decreased in five of six volunteer subjects (by greater than 30% in three subjects) although this decrease was not shown to be statistically significant."( The effect of activated dimethicone and a proprietary antacid preparation containing this agent on the absorption of phenytoin.
Collier, PS; McElnay, JC; Uprichard, G, 1982
)
0.26
"The effect of Mylanta on naproxen bioavailability was studied in 11 healthy volunteers."( Effect of Mylanta on naproxen bioavailability.
Bankhurst, AD; Ding, TL; Mroszczak, E; Weber, SS, 1981
)
0.26
" The slight increase of the ethyl biscoumacetate bioavailability with dimeticone in repeated dosing might have pharmacodynamic consequence; a clinical trial should address this question."( [Effect of dimethicone on pharmacokinetics and pharmacodynamics of ethyl biscoumacetate].
Chanteclair, G; Copie, X; de Lauture, D; Letrait, M; Olive, G; Paltiat, MH; Pello, JY; Pinquier, JL; Rey, E; Strauch, G,
)
0.13
" However, this treatment had no significant effect on the bioavailability and the elimination of R and S enantiomers, as shown by AUC, t1/2 and MRT values."( Effect of dimethicone (polysilane gel) on the stereoselective pharmacokinetics of ketoprofen.
Bannwarth, B; Gillet, P; Herrmann, MA; Lapicque, F; Netter, P; Presle, N, 1998
)
0.3
" Dimethicone did not significantly alter the bioavailability of ketoprofen, chosen as an example of an NSAID, especially that of the pharmacologically active S enantiomer."( Effect of dimethicone (polysilane gel) on the stereoselective pharmacokinetics of ketoprofen.
Bannwarth, B; Gillet, P; Herrmann, MA; Lapicque, F; Netter, P; Presle, N, 1998
)
0.3
" Bioavailability parameters, maximum plasma concentration and area under the plasma concentration-time curve to infinity of ceftibuten were unaffected by treatment with antacid."( Pharmacokinetic drug interaction study: administration of ceftibuten concurrently with the antacid mylanta double- strength liquid or with ranitidine.
Affrime, M; Cutler, D; Lin, CC; Nomeir, A; Radwanski, E, 1998
)
0.3
" As a part of the fixed-dose combination registration process in Mexico, a pharmacokinetic and relative bioavailability study was carried out to demonstrate nonexistence of pharmacokinetic interaction when mosapride is administered alone or in combination with pancreatin and simethicone using DOSIER® (mosapride) 5-mg tablets as a reference product."( Relative bioavailability and pharmacokinetic comparison of a fixed-dose combination tablet of mosapride, pancreatin, and simethicone relative to single-component mosapride tablets in healthy Mexican subjects.
Argüelles Tello, FA; Camarillo Cárdenas, KP; García González, J; Moreno Hernández, JB; Ocampo Ramírez, JA; Pendela, MM, 2022
)
1.11

Dosage Studied

The combination of simethicone plus Colyte administered the night before colonoscopy improves visibility by diminishing bubbles. The method can be found in the USP monographs for several dosage forms of Simethicone-containing pharmaceutical products.

ExcerptRelevanceReference
" These data indicate that (a) the combination of simethicone plus Colyte administered the night before colonoscopy improves visibility by diminishing bubbles; (b) this dosage of simethicone is not effective in diminishing haziness when administered the night before colonoscopy; and (c) patients with diverticulosis are likely to have feculent debris in the rectosigmoid colon, and a precolonoscopy enema may be helpful when the diagnosis is known."( The effect of simethicone on colonic visibility after night-prior colonic lavage. A double-blind randomized study.
Maydonovitch, CL; McNally, PR; Wong, RK, 1989
)
0.89
"A long-acting dosage form for local use of gentamicin immobilized on polymethylsiloxane, a silicon organic adsorbent was developed."( [Study of general toxic properties and side effects of polymethylsiloxane and gentamicin immobilized on it].
Cherviak, PI; Kaban, AP; Keĭsevich, LV; Samodumova, IM; Znamenskiĭ, VA, 1988
)
0.27
" This is possibly due to a higher dosage of dimethycon in Paractol."( [Premedication for abdominal sonography--comparison of the efficacy of 2 dimethicone preparations].
Elfner, R; Gladisch, R; Massner, B; Ulrich, H, 1985
)
0.27
"5 micrograms/ml were maintained for the entire dosing interval in seven of 10 subjects."( Effect of antacids on predicted steady-state cimetidine concentrations.
Doering, PL; Guild, RT; Lopez, LM; Normann, SA; Russell, WL, 1984
)
0.27
"Over a 15-month period, 75 critically ill patients at risk of acute gastrointestinal bleeding were randomized into two groups: one group (38 patients) received the H2-blocker cimetidine intravenously at an initial dosage of 300 mg every six hours, and the other group (37 patients) received antacid (Mylanta II) through a nasogastric tube at an intial dosage of 30 ml every hour."( Antacid versus cimetidine in preventing acute gastrointestinal bleeding. A randomized trial in 75 critically ill patients.
Bushnell, LS; Long, PC; Priebe, HJ; Silen, W; Skillman, JJ, 1980
)
0.26
" Twice a day dosage is likely to improve patient compliance, costs less, and may reduce dose-related side effects."( Twice-a-day dosage of cimetidine in the short-term treatment of peptic ulcer.
Eaves, R; Korman, MG, 1982
)
0.26
" The slight increase of the ethyl biscoumacetate bioavailability with dimeticone in repeated dosing might have pharmacodynamic consequence; a clinical trial should address this question."( [Effect of dimethicone on pharmacokinetics and pharmacodynamics of ethyl biscoumacetate].
Chanteclair, G; Copie, X; de Lauture, D; Letrait, M; Olive, G; Paltiat, MH; Pello, JY; Pinquier, JL; Rey, E; Strauch, G,
)
0.13
" No adverse reactions were found in rabbits following short-term dermal dosing with 6% to 79% Dimethicone, yet adverse effects were noted with a hand cream formulation containing 1% Dimethicone, suggesting something else in the preparation was toxic."( Final report on the safety assessment of stearoxy dimethicone, dimethicone, methicone, amino bispropyl dimethicone, aminopropyl dimethicone, amodimethicone, amodimethicone hydroxystearate, behenoxy dimethicone, C24-28 alkyl methicone, C30-45 alkyl methico
Nair, B, 2003
)
0.32
" The method can be found in the USP monographs for several dosage forms of Simethicone-containing pharmaceutical products."( Improvements in soft gelatin capsule sample preparation for USP-based simethicone FTIR analysis.
Hargis, AD; Whittall, LB, 2013
)
0.85
" However, the optimal dose, volume, and dosing time for the premedication regimen are still unclear."( Efficacy of simethicone and N-acetylcysteine as premedication in improving visibility during upper endoscopy.
Chang, WK; Chen, HW; Hsu, HC; Hu, MK; Yeh, MK, 2014
)
0.78
" Utilizing a 90-day BUD, lidocaine can be packaged separately from other magic mouthwash ingredients in individual dosage units and applied to the oral cavity using the swish-and-spit method."( Beyond-use dating of lidocaine alone and in two "magic mouthwash" preparations.
Brown, SD; Huffman, J; Kirk, LM; Lewis, PO; Luu, Y; Ogle, A, 2017
)
0.46
" After 10 s, photographs were taken and the visible bubbles were semi-quantitatively rated by independent assessors blinded to the dosing of simethicone."( An in vitro and clinical dose-finding study of antifoaming effects of simethicone during colonoscopy.
Elson, J; Holtmann, GJ; Hourigan, LF; Kutyla, MJ; Meeusen, V; O'Connor, S; Shah, A, 2019
)
0.95
" The rate of total BBPS score ≥6 remained significantly higher in the SIM group when a single-dose laxative regimen or a SIM dosage of ≥320 mg was employed; and ADR, PDR and CIR were significantly increased in the SIM group among colonoscopy clinicians who achieved an ADR <31%, PDR <45% and CIR <96%, respectively."( Effect of oral simethicone on the quality of colonoscopy: A systematic review and meta-analysis of randomized controlled trials.
Cao, RR; Gao, C; Li, HY; Pan, JH; Qi, XS; Wang, L; Yoshida, EM, 2022
)
1.07
"Oral SIM can improve bowel preparation quality, especially in patients receiving a SIM dosage of ≥320 mg or a single-dose laxative regimen."( Effect of oral simethicone on the quality of colonoscopy: A systematic review and meta-analysis of randomized controlled trials.
Cao, RR; Gao, C; Li, HY; Pan, JH; Qi, XS; Wang, L; Yoshida, EM, 2022
)
1.07
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Occurs in Manufacturing (27 Product(s))

Product Categories

Product CategoryProducts
Other4
Alimentos e bebidas à base de plantas,Alimentos à base de plantas,Gorduras,Gorduras vegetals,Produtos de oliveira,Olios vegetais,Azeite de oliva,Azeites virgem extra1
Condiments, Sauces, Sauces samouraï1
en:stuffed-pastas1
Aliments et boissons à base de végétaux, Aliments d'origine végétale, Condiments, Epices, Poivres, Poivres noirs, Poivres moulus, Poivre noir moulu, en:groceries1
Beauty & Personal Care19

Products

ProductBrandCategoryCompounds Matched from IngredientsDate Retrieved
Good Clean Love Rebalance Moisturizing & Cleansing Wipes -- 30 WipesGood Clean LoveBeauty & Personal Caregoldenseal, gluconic acid, lactic acid, propanediol, simethicone, sodium benzoate2024-11-29 10:47:42
Good Clean Love Rebalance Personal Moisturizing & Cleansing Wipes -- 12 WipesGood Clean LoveBeauty & Personal Caregoldenseal, gluconic acid, lactic acid, propanediol, simethicone, sodium benzoate2024-11-29 10:47:42
Herbatint Permanent Hair Color Gel 10C Swedish Blonde -- 135 mLHerbatintBeauty & Personal Careisopropyl alcohol, citric acid, cetyl alcohol, citric acid, ethanolamine, etidronic acid, imidazolidinyl urea, oleic acid, propylene glycol, simethicone, sodium benzoate, sodium metabisulfite2024-11-29 10:47:42
Herbatint Permanent Hair Color Gel 2N Brown -- 135 mLHerbatintBeauty & Personal Carecitric acid, p-phenylenediamine, cetyl alcohol, citric acid, ethanolamine, etidronic acid, imidazolidinyl urea, oleic acid, propylene glycol, simethicone, sodium benzoate, sodium metabisulfite2024-11-29 10:47:42
Herbatint Permanent Hair Color Gel 3N Dark Chestnut -- 135 mLHerbatintBeauty & Personal Careisopropyl alcohol, P-phenylenediamine, cetyl alcohol, ethanolamine, etidronic acid, imidazolidinyl urea, propylene glycol, simethicone, sodium benzoate2024-11-29 10:47:42
Herbatint Permanent Hair Color Gel 4M Mahogany Chestnut -- 135 mLHerbatintBeauty & Personal Care2-amino-3-hydroxypyridine, m-aminophenol, p-aminophenol, p-phenylenediamine, cetyl alcohol, ethanolamine, etidronic acid, imidazolidinyl urea, methyl benzoate, propylene glycol, simethicone2024-11-29 10:47:42
Herbatint Permanent Hair Color Gel 4N Chestnut -- 135 mLHerbatintBeauty & Personal Carep-phenylenediamine, cetyl alcohol, ethanolamine, etidronic acid, imidazolidinyl urea, oleic acid, propylene glycol, simethicone, sodium benzoate2024-11-29 10:47:42
Herbatint Permanent Hair Color Gel 5N Light Chestnut -- 135 mLHerbatintBeauty & Personal Carep-phenylenediamine, ethanolamine, oleic acid, propylene glycol, simethicone, sodium metabisulfite2024-11-29 10:47:42
Herbatint Permanent Hair Color Gel 6N Dark Blonde -- 135 mLHerbatintBeauty & Personal Carecitric acid, cetyl alcohol, citric acid, ethanolamine, etidronic acid, imidazolidinyl urea, oleic acid, propylene glycol, simethicone, sodium benzoate, sodium metabisulfite2024-11-29 10:47:42
Herbatint Permanent Hair Color Gel 7N Blonde -- 135 mLHerbatintBeauty & Personal Careisopropyl alcohol, citric acid, p-phenylenediamine, cetyl alcohol, citric acid, ethanolamine, etidronic acid, imidazolidinyl urea, oleic acid, propylene glycol, simethicone, sodium metabisulfite2024-11-29 10:47:42
Herbatint Permanent Hair Color Gel 8N Light Blonde -- 135 mLHerbatintBeauty & Personal Careisopropyl alcohol, citric acid, cetyl alcohol, citric acid, ethanolamine, etidronic acid, imidazolidinyl urea, oleic acid, propylene glycol, simethicone, sodium benzoate2024-11-29 10:47:42
Herbatint Permanent Hair Color Gel 9N Honey Blonde -- 135 mLHerbatintBeauty & Personal Careisopropyl alcohol, citric acid, p-phenylenediamine, cetyl alcohol, citric acid, etidronic acid, oleic acid, propylene glycol, simethicone, sodium metabisulfite2024-11-29 10:47:42
MyChelle Dermaceuticals Protect Sun Shield Sunscreen SPF 28 Coconut -- 2.3 fl ozMyChelle DermaceuticalsBeauty & Personal Careallantoin, cetearyl alcohol, glycerin, simethicone, squalane, Titanium Dioxide2024-11-29 10:47:42
Vanicream Cleansing Bar Soap Fragrance Free -- 3.9 ozVanicreamBeauty & Personal Carecetearyl alcohol, glyceryl stearate, propanediol, sodium lauroyl sarcosinate, simethicone, sorbitol, stearic acid2024-11-29 10:47:42
Vanicream HC 1% Hydrocortizone Anti-Itch Cream For Sensitive Skin -- 2 ozVanicreamBeauty & Personal Carecetearyl alcohol, glyceryl stearate, propanediol, simethicone, sorbic acid2024-11-29 10:47:42
Vanicream Moisturizing Cream -- 16 ozVanicreamBeauty & Personal Carecetearyl alcohol, glyceryl stearate, propylene glycol, simethicone, sorbic acid, sorbitol2024-11-29 10:47:42
Vanicream Moisturizing Cream For Sensitive Skin Travel Tube -- 2 fl ozVanicreamBeauty & Personal CareBHT, cetearyl alcohol, glyceryl stearate, propylene glycol, simethicone, sorbic acid, sorbitol2024-11-29 10:47:42
Vanicream Moisturizing Lotion -- 16 fl ozVanicreamBeauty & Personal Carecetearyl alcohol, glyceryl stearate, propylene glycol, simethicone, sorbic acid, sorbitol2024-11-29 10:47:42
Vanicream Moisturizing Skin Cream with Pump Dispenser Fragrance Free -- 16 ozVanicreamBeauty & Personal Carecetearyl alcohol, glyceryl stearate, propylene glycol, simethicone, sorbic acid2024-11-29 10:47:42

Research

Studies (364)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990108 (29.67)18.7374
1990's65 (17.86)18.2507
2000's62 (17.03)29.6817
2010's95 (26.10)24.3611
2020's34 (9.34)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 (%)
Trials167 (42.17%)5.53%
Reviews35 (8.84%)6.00%
Case Studies26 (6.57%)4.05%
Observational1 (0.25%)0.25%
Other167 (42.17%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (49)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
The Effects of Moviprep With Simethicone on Colonic Bubbles [NCT01209806]140 participants (Actual)Interventional2009-11-30Completed
Optimization of Simethicone Administration Strategy Before Esophagogastroscopy [NCT03776916]311 participants (Actual)Interventional2019-05-01Completed
Multicenter, Randomized, Parallel-group, Open-label, Comparative Clinical Study to Evaluate Efficacy and Safety of Mebeverine+Simethicone Fixed-dose Combination Versus Duspatalin® (Mebeverine) and Versus Espumisan® (Simethicone) in Patients With Functiona [NCT05175131]Phase 3465 participants (Actual)Interventional2020-11-27Completed
Effects of Simethicone and Vivatlac Baby in Infantile Colic [NCT04487834]Phase 287 participants (Actual)Interventional2020-04-16Completed
Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy: a Prospective Randomized Controlled Study [NCT03662113]200 participants (Actual)Interventional2017-11-01Completed
Effect of Simethicone on Reducing Bowel Interference During Minilaparotomy for Tubal Resection : a Randomized Controlled Trial [NCT03429621]Phase 3120 participants (Actual)Interventional2018-03-08Completed
Simethicone Pretreatment With Low-volume Polyethylene Glycol-3350 and Bisacodyl in an Effort to Improve Bowel Wall Visualization During Colonoscopy [NCT03410524]Phase 3250 participants (Actual)Interventional2018-01-09Completed
Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain [NCT01269671]Phase 10 participants (Actual)Interventional2011-01-31Withdrawn(stopped due to PI has left institution)
Ingestion of Simethicone After Capsule Ingestion and Its Impact on Quality of Video Capsule Endoscopy- a Pilot Study [NCT03166605]36 participants (Anticipated)Interventional2017-05-03Recruiting
A Randomized Controlled Trial of the Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery: A Pilot Study [NCT02161367]Phase 4100 participants (Actual)Interventional2014-10-31Completed
Sodium Sulfate/Potassium Sulfate/Magnesium Sulfate Bowel Preparation With and Without Simethicone for Routine Colonoscopy: A Double-blinded Randomized Controlled Trial [NCT02523911]0 participants (Actual)Interventional2016-03-31Withdrawn(stopped due to investigator graduated and is not longer at this institution)
Use of Simethicone to Improve the Bowel Cleansing Effects of Polyethylene Glycol With Ascorbic Acid for Colonoscopy [NCT02548403]Phase 3260 participants (Actual)Interventional2014-07-31Completed
A Relative Bioavailability Study of Loperamide HCl 2 mg and Simethicone 125 mg Tablets to Imodium® Advanced Caplets Under Fasting Condition [NCT00778115]26 participants (Actual)Interventional2004-11-30Completed
[NCT02540239]590 participants (Actual)Interventional2015-01-31Completed
An Open-Label, 3-Period, Fixed-Sequence, Study to Examine the Effect of Aluminum Hydroxide/Magnesium Hydroxide/Simethicone and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects [NCT04368585]Phase 120 participants (Actual)Interventional2020-07-01Completed
Pre-medication With N-acetylcysteine and Simethicone to Improve Mucosal Visibility During Gastroduodenoscopy: A Double Blind, Randomized Controlled Trial. [NCT05951712]800 participants (Actual)Interventional2022-06-16Completed
A Placebo-Controlled, Double-Blind, Randomized Pilot Study to Evaluate the Appropriateness of Multiple Endpoints in Measuring the Onset of Clinical Efficacy of Loperamide-Simethicone Caplets in the Treatment of Acute Non-specific Diarrhea [NCT00685607]Phase 445 participants (Actual)Interventional2008-10-31Completed
Efficacy of Fixed-dose Combination of Bromopride and Simethicone Versus Isolated Bromopride in Participants With Functional Dyspepsia. [NCT02604576]Phase 3339 participants (Actual)Interventional2017-01-17Completed
A Double Blinded Randomized Controlled Trial for the Management of Pediatric Community Acquired Skin Abscesses - To Treat or Not to Treat With Antibiotics [NCT00679302]Phase 4161 participants (Actual)Interventional2006-07-31Completed
The Effectiveness of Simethicone In Improving Visibility During Colonoscopy: A Randomized, Placebo-controlled Study [NCT00615303]Phase 4194 participants (Actual)Interventional2006-12-31Completed
A Randomized, Parallel Group Comparison of Loperamide/Simeticone Caplet, Loperamide/Simeticone Chewable Tablet (IMODIUM® PLUS) and a Probiotic (Saccharomyces Boulardii) in the Treatment of Acute Diarrhea in Adults [NCT00807326]Phase 4415 participants (Actual)Interventional2008-11-30Completed
Effects of Simethicone and Multilac Baby on Fecal Calprotectin Levels Infantile Colic [NCT04666324]100 participants (Anticipated)Interventional2020-12-31Not yet recruiting
Trimebutine Maleate (NEWBUTIN SR 300 mg Tab) as a Prophylactic Anti-emetic Drug for Patients Who Underwent Arthroscopic Rotator Cuff Repair: a Randomized Controlled Study [NCT01984931]Phase 345 participants (Anticipated)Interventional2013-10-31Recruiting
A Pilot Study of the Effect of Simethicone in Adult Subjects With a Common Cold on Eustachian Tube Dysfunction [NCT01312038]Phase 225 participants (Actual)Interventional2011-03-31Completed
An Open-label, Randomized, Fasting, Two-period, Single-dose, Crossover Study to Assess Bioequivalence Between a Combination Caplet With Loperamide Hydrochloride and Simethicone (Janssen-Cilag, France), and Imodium® Express Tablets-lyophilizate (Janssen-Ci [NCT04186936]Phase 148 participants (Actual)Interventional2019-12-05Completed
Gastric Preparation of Magnetic-controlled Capsule Endoscopy: A Prospective, Single Blinded and Randomized Controlled Trial [NCT02846155]Phase 2120 participants (Anticipated)Interventional2016-05-31Recruiting
Assessment of Combined Bowel Preparation for Capsule Endoscopy Study [NCT01243736]Phase 150 participants (Actual)Interventional2010-04-30Completed
Comparison of Low-volume Versus High-volume Polyethylene Glycol Based Bowel Preparation for Colonoscopy in People Receiving Hemodialysis: a Randomized Non-inferiority Trial [NCT04709770]Phase 4264 participants (Anticipated)Interventional2021-02-01Not yet recruiting
The Impact of Air Travel on Passenger Cognitive Functions [NCT04802785]Phase 2/Phase 350 participants (Anticipated)Interventional2021-06-30Not yet recruiting
Effect of Adding Simethicone to a Split Regimen of Polyethylene Glycol for Bowel Preparation in a Colorectal Cancer Screening Colonoscopy Setting: an Endoscopist-blinded Randomized Controlled Trial [NCT03816774]412 participants (Actual)Interventional2019-06-15Completed
Efficacy of a Standardized Extract of Matricariae Chamomilla L., Melissa Officinalis L. and Tyndallized Lactobacillus Acidophilus (H122) Compared With Lactobacillus Reuteri (DSM 17938) and With Simethicone for the Treatment of Infantile Colic [NCT02708238]Phase 4180 participants (Actual)Interventional2014-04-30Completed
Effectiveness of Premedication With Simethicone or Simethicone Plus N-acetylcysteine vs. Placebo in Improving Visibility During Upper Endoscopy. [NCT01653171]Phase 4230 participants (Actual)Interventional2012-07-31Completed
Simethicone and Gynecological Laparoscopies: Does it Improve Operative Field and Postoperative Pain? [NCT02984176]Phase 4100 participants (Actual)Interventional2014-08-31Completed
EFFICACY, TOLERABILITY, AND SAFETY OF DIFFERENT BOWEL PREPARATIONS FOR COLONOSCOPY IN CHILDREN [NCT01711437]Phase 4400 participants (Anticipated)Interventional2011-01-31Recruiting
Efficacy of the Combination Therapy With Alverine-simeticone and i3.1 Probiotic Formula in the Quality of Life of Patients With IBS-D or IBS-M in Hospital Juarez Mexico [NCT04145856]Phase 455 participants (Actual)Interventional2018-09-03Completed
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 [NCT05109390]Phase 172 participants (Actual)Interventional2018-07-27Completed
Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning Using a 2lt PEG-CS With Simethicone: a Randomized Controlled Study. [NCT05570669]Phase 4321 participants (Actual)Interventional2021-05-25Completed
Nutritional Intervention, Multicenter, Randomized, Blind, Parallel Groups Study to Assess the Effect of Consumption of Bifidobacterium Breve CECT7263 and Lactobacillus Fermentum CECT5716 on Infant Colic [NCT03467334]Phase 2156 participants (Actual)Interventional2017-05-31Completed
[NCT03009604]Phase 390 participants (Anticipated)Interventional2017-01-31Recruiting
Benefits of Premedication With Small Volume Simethicone Solution Before Diagnostic Gastroscopy: A Randomized Endoscopist-blinded Prospective Study [NCT02555228]Phase 2/Phase 354 participants (Actual)Interventional2015-08-31Completed
The Effect Of Adding High Dose Simethicone To A Standard Polyethylene Glycol Preparation On Adenoma Detection Rate During Screening Colonoscopy: A Randomized Controlled Pilot Trial [NCT03119168]Phase 4268 participants (Actual)Interventional2017-03-15Completed
Oral Iohexol for Fecal/Fluid Tagging for CT Colonography: A Study to Improve Image Quality by Preventing Colonic Bubbles [NCT01790139]84 participants (Actual)Interventional2013-02-28Completed
Comparison Between Asymmetric (Low Dose In The Morning) And Standard Split-Dose Regimen Of Polyethylene Glycol Plus Bisacodyl For Bowel Preparation For Screening And Surveillance Colonoscopy: A Randomized Non-Inferiority Clinical Trial. [NCT03146052]81 participants (Actual)Interventional2017-03-27Completed
Premedication With Simethicone and N-acetylcysteine in Improving Mucosal Visibility During Upper Endoscopy - a Prospective Double-blinded Randomized Controlled Trial [NCT02357303]Phase 4300 participants (Actual)Interventional2015-04-30Completed
The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION Trial): Protocol of a Multicentre Randomized Controlled Clinical Trial [NCT05100719]200 participants (Anticipated)Interventional2022-09-30Not yet recruiting
A Multi-center, Randomized, Double-blind, Double-dummy, and Parallel Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Loperamide Hydrochloride/Simethicone Chewable Tablet in the Treatment of Acute Diarrhea With Abdominal Discomfort and Flat [NCT02340481]Phase 3217 participants (Actual)Interventional2005-07-31Completed
A Double Blind Randomized Controlled Trial of High Volume Simethicone to Improve Visualization During Capsule Endoscopy [NCT02334631]Phase 4159 participants (Actual)Interventional2017-01-31Completed
Addition of Oral Simethicone to Bowel Preparation in Colonoscopy [NCT03157791]Phase 4471 participants (Actual)Interventional2017-07-05Completed
A Pilot Study to Assess Dimethyl Fumarate (Tecfidera) Related GI Symptom Mitigation Via Food Bolus Alteration and Simethicone/Loperamide Administration [NCT02217982]Phase 45 participants (Actual)Interventional2014-07-31Terminated(stopped due to Study did not meet required enrollment numbers)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00679302 (2) [back to overview]New Lesion Development and Spread of Skin Abscesses (on Subject)
NCT00679302 (2) [back to overview]Skin Abscess Resolution
NCT01312038 (1) [back to overview]Fraction of Middle Ear (ME) Pressure Equilibrated (FGE)
NCT02217982 (2) [back to overview]Diarrhea Reduction
NCT02217982 (2) [back to overview]Reported GI Symptoms
NCT02555228 (4) [back to overview]Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution
NCT02555228 (4) [back to overview]Total Cumulative Mucosal Visibility Score
NCT02555228 (4) [back to overview]Volume of Additional Manual Flushes Required During Endoscopy in Mls
NCT02555228 (4) [back to overview]Mucosal Visibility Score Per Area as Determined by Mc Nally Score:
NCT02708238 (2) [back to overview]Median Daily Crying Time at the End of the Treatment
NCT02708238 (2) [back to overview]Number of Responders
NCT03119168 (4) [back to overview]Adenoma Detection Rate
NCT03119168 (4) [back to overview]Intraprocedural Use of Simethicone
NCT03119168 (4) [back to overview]Withdrawal Times
NCT03119168 (4) [back to overview]Colon Preparation
NCT04487834 (3) [back to overview]Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent
NCT04487834 (3) [back to overview]Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent
NCT04487834 (3) [back to overview]Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline

New Lesion Development and Spread of Skin Abscesses (on Subject)

The secondary outcomes of interest included the development of new lesions at a different site (>5cm away from original skin abscess) on day 10 clinical follow-up or self-report and 3 month telephone follow-up. (NCT00679302)
Timeframe: 10-14 days and 3 month

Interventionparticipants (Number)
Placebo Group15
Antibiotic Group13

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Skin Abscess Resolution

(NCT00679302)
Timeframe: 10-14 days

Interventionparticipants (Number)
Placebo Group4
Antibiotic Group3

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Fraction of Middle Ear (ME) Pressure Equilibrated (FGE)

The proportion of the pressure chamber-ME pressure gradient equilibrated with 1 swallow (NCT01312038)
Timeframe: After achieving the desired ME-pressure chamber gradient at baseline and 30 min post treatment

,
Interventionratio (Mean)
Pre treatment FGE at -200 daPapost-treatment FGE at -200 daPaPre -treatment FGE at 200 daPaPost-treatment FGE at 200 daPa
Placebo0.240.230.300.34
Simethicone-treated0.170.190.240.24

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Diarrhea Reduction

The secondary objective is to assess the reduction in diarrhea in the treatment group compared to the control. (NCT02217982)
Timeframe: 7 Weeks

Intervention ()
Control Group0
Treatment Arm0

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Reported GI Symptoms

The primary endpoint will be severity of GI events as measured by the MAGIS scale for subjects in the treatment arm compared to the standard therapy arm. (NCT02217982)
Timeframe: 7 Weeks

Intervention ()
Control Group0
Treatment Arm0

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Total Cumulative Mucosal Visibility Score

"Total cumulative mucosal visibility score (TMVS) of all areas during the gastroscopy as determined by Mc Nally score:~Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured~Total areas covered:~(E) esophagus (D) duodenum (A) Antrum and angularis (B) body and fundus" (NCT02555228)
Timeframe: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.

Interventionunits (Mean)
Simethicone Premedication5.78
Placebo8.89

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Volume of Additional Manual Flushes Required During Endoscopy in Mls

The volume of additional water (in mls) flushed during the gastroscopy in order to remove obscuring foam or bubbles. (NCT02555228)
Timeframe: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.

Interventionmls (Mean)
Simethicone Premedication3.89
Placebo84.81

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Mucosal Visibility Score Per Area as Determined by Mc Nally Score:

"Area E: esophagus~Area D: duodenum~Area A: antrum and angularis~Area B: body and fundus~Mc Nally score per area:~Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured" (NCT02555228)
Timeframe: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.

,
Interventionunits on a scale (Mean)
Area E (esopahgus)Area D (duodenum)Area A (antrum and angularis)Area B (body and fundus)
Placebo1.592.262.562.44
Simethicone Premedication1.481.261.301.74

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Median Daily Crying Time at the End of the Treatment

Median daily crying at the end of treatment (day 28). (NCT02708238)
Timeframe: 28 days of treatment

Interventionminutes (Median)
Group A50
Group B55
Group C80

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Number of Responders

Number of responders defined as the number of patients who experienced a decrease in the daily average crying time of 50% from baseline (NCT02708238)
Timeframe: 28 days of treatment

Interventionnumber of responders (Number)
Group A57
Group B47
Group C38

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Adenoma Detection Rate

The number of adenomatous polyps removed at colonoscopy (NCT03119168)
Timeframe: 25 minutes

Interventionadenomas (Number)
Simethicone Solution + Polyethylenglycol43
Polyethylenglycol54

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Intraprocedural Use of Simethicone

The number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope. (NCT03119168)
Timeframe: 6-10 minutes

Interventioncolonoscopies (Number)
Simethicone Solution + Polyethylenglycol2
Polyethylenglycol68

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Withdrawal Times

Amount spent withdrawing the scope during the colonoscopy (NCT03119168)
Timeframe: 6-10 minutes

Interventionseconds (Mean)
Simethicone Solution + Polyethylenglycol395.7
Polyethylenglycol399

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Colon Preparation

"Boston Bowel Preparation Scale (BBPS): scale that rates the quality of the colon preparation based on the amount of stool present. 0:solid stool that cannot be cleared; 1:areas not well seen due to residual stool and/or opaque liquid; 2:small fragments of stool and/or opaque liquid, but mucosa seen well; 3:no residual stool or opaque liquid seen. Score determined by adding the score of each individual segment of the colon (right side, transverse and left side). Scores range from 0 to 3 in each segment, therefore, a total composite score ranges from 0 (poor) to 9 (excellent).~Bubble Score (BS): scale that rates the amount of bubbles present in the colon. 0:no or minimal bubbles; 1:bubbles covering up to half the luminal diameter; 2:bubbles covering the circumference of the lumen; 3:bubbles filling the entire lumen. Score determined the same way as BBPS score but in this case a total score of 0 is excellent and 9 is poor." (NCT03119168)
Timeframe: 25 minutes

,
Interventionscore on a scale (Mean)
Boston Bowel Preparation ScaleBubble Scale
Polyethylenglycol8.92.1
Simethicone Solution + Polyethylenglycol8.90.1

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Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent

Measurement of average duration of evening crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment. (NCT04487834)
Timeframe: Three weeks

InterventionParticipants (Count of Participants)
Simethicone Solution13
Vivatlac Baby46

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Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent

Measurement average number of crying phases per day during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment. (NCT04487834)
Timeframe: Three weeks

InterventionParticipants (Count of Participants)
Simethicone Solution14
Vivatlac Baby27

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Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline

Measurement of days of crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment. (NCT04487834)
Timeframe: Three weeks

InterventionParticipants (Count of Participants)
Simethicone Solution6
Vivatlac Baby39

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