Page last updated: 2024-12-05

mebeverine

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

Description

Mebeverine is a synthetic antispasmodic medication that is used to treat irritable bowel syndrome (IBS) and other gastrointestinal disorders. It acts by blocking the action of acetylcholine, a neurotransmitter that stimulates muscle contractions in the digestive tract. Mebeverine is typically well-tolerated, but common side effects include constipation, dry mouth, and dizziness. The synthesis of mebeverine involves several steps, starting with the reaction of 4-aminobenzoic acid with ethyl chloroformate. This is followed by a series of reactions to introduce the mebeverine side chain. Mebeverine is studied because of its potential to treat a wide range of gastrointestinal disorders. Researchers are investigating its effectiveness in treating conditions such as functional dyspepsia, diarrhea-predominant IBS, and inflammatory bowel disease.'

mebeverine: RN given refers to parent cpd; structure [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

gamma-oryzanol: present in rice bran is associated with various physiological functions; RN given refers to gamma-oryzanol [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID4031
CHEMBL ID282121
CHEBI ID91514
SCHEMBL ID25804
MeSH IDM0046424
PubMed CID89468
MeSH IDM0046424

Synonyms (86)

Synonym
BRD-A09467419-003-04-2
KBIO1_000045
DIVK1C_000045
mebeverine
4-(ethyl{1-methyl-2-[4-(methyloxy)phenyl]ethyl}amino)butyl 3,4-bis(methyloxy)benzoate
3625-06-7
SPECTRUM_000435
PRESTWICK2_000310
BPBIO1_000308
SPECTRUM5_001315
BSPBIO_000280
IDI1_000045
PRESTWICK3_000310
veratric acid, 4-[ethyl(p-methoxy-.alpha.-methylphenethyl)amino]-, butyl ester-
4-(ethyl(2-(4-methoxyphenyl)-1-methylethyl)amino)butyl 3,4-dimethoxybenzoate
mebeverine (usan)(*hydrochloride*)
4-[ethyl-[2-(4-methoxyphenyl)-1-methyl-ethyl]amino]butyl 3,4-dimethoxybenzoate
benzoic acid, 3,4-dimethoxy-, {4-[ethyl[2-(4-methoxyphenyl)-1-methylethyl]amino]butyl} ester
AB00053597
mebeverina [inn-spanish]
brn 2783282
veratric acid, 4-((ethyl(p-methoxy-alpha-methylphenethyl))amino)butyl ester
benzoic acid, 3,4-dimethoxy-, 4-(ethyl(2-(4-methoxyphenyl)-1-methylethyl)amino)butyl ester
mebeverine [inn:ban]
einecs 222-830-4
mebeverinum [inn-latin]
KBIOGR_001513
KBIO3_001896
KBIO2_006051
KBIO2_000915
KBIO2_003483
KBIOSS_000915
PRESTWICK1_000310
SPBIO_002499
SPBIO_001448
PRESTWICK0_000310
SPECTRUM4_001017
SPECTRUM3_000918
NINDS_000045
SPECTRUM2_001404
arluy
CHEMBL282121
D08160
mebeverine (inn)
arluy (tn)
4-[ethyl-[1-(4-methoxyphenyl)propan-2-yl]amino]butyl 3,4-dimethoxybenzoate
NCGC00018277-02
unii-7f80cc3nnv
mebeverina
mebeverinum
7f80cc3nnv ,
veratric acid, 4-((ethyl(p-methoxy-.alpha.-methylphenethyl))amino)butyl ester
4-(ethyl(p-methoxy-.alpha.-methylphenethyl)amino)butyl veratrate
mebeverine [inn]
mebeverine [who-dd]
mebeverine [mi]
SCHEMBL25804
AKOS025141920
4-[ethyl(p-methoxy-.alpha.-methylphenethyl)amino]butyl veratrate
4-(ethyl[2-(4-methoxyphenyl)-1-methylethyl]amino)butyl 3,4-dimethoxybenzoate #
VYVKHNNGDFVQGA-UHFFFAOYSA-N
benzoic acid, 3,4-dimethoxy-, 4-[ethyl[2-(4-methoxyphenyl)-1-methylethyl]amino]butyl ester
3,4-dimethoxybenzoic acid 4-[ethyl-[2-(4-methoxyphenyl)-1-methyl-ethyl]amino]butyl ester
AB00053597_13
DTXSID6023238
gtpl9011
4-{ethyl[1-(4-methoxyphenyl)propan-2-yl]amino}butyl 3,4-dimethoxybenzoate
STL483420
CHEBI:91514
3,4-dimethoxybenzoic acid 4-[ethyl-[1-(4-methoxyphenyl)propan-2-yl]amino]butyl ester
SBI-0051645.P002
DB12554
4-(ethyl(1-(4-methoxyphenyl)propan-2-yl)amino)butyl 3,4-dimethoxybenzoate
3,4-dimethoxybenzoic acid 4-[ethyl[2-(4-methoxyphenyl)-1-methylethyl]amino]-butylester
Q418167
BRD-A09467419-003-14-1
EN300-19767755
AS-75957
9,19-cyclolanost-24-en-3-yl 3-(4-hydroxy-3-methoxyphenyl)prop-2-enoate
gamma-oryzanol
11042-64-1
FT-0626619
AKOS030228301
BCP13528
(c)(3/4)-oryzanol;gamma oryzanol
DTXSID20860087

Research Excerpts

Overview

Mebeverine HCl is a water soluble drug commonly used to treat irritable bowel syndrome by acting directly on the smooth muscles of the colon. It is an ester of veratric acid and 4-(ethyl)-1-methylethyl]amino)butan-1-ol.

ExcerptReferenceRelevance
"Mebeverine is a musculotropic agent that potently blocks intestinal peristalsis."( Role of antispasmodics in the treatment of irritable bowel syndrome.
Annaházi, A; Róka, R; Rosztóczy, A; Wittmann, T, 2014
)
1.12
"Mebeverine HCl is a water soluble drug commonly used to treat irritable bowel syndrome by acting directly on the smooth muscles of the colon. "( Preparation and in vitro evaluation of mebeverine HCl colon-targeted drug delivery system.
Abdulkarim, MF; Abdullah, GZ; Ameer, OZ; Chitneni, M; Mutee, AF; Noor, AM; Salman, IM, 2011
)
2.08
"Mebeverine-alcohol is a precursor for a number of amphetamine-like compounds."( Investigative implications of the instability and metabolism of mebeverine.
Burgess, V; Elliott, S, 2006
)
1.29
"Mebeverine, which is an ester of veratric acid and 4-(ethyl-[2-(4-methoxyphenyl)-1-methylethyl]amino)butan-1-ol, was completely hydrolysed to the corresponding acid and alcohol moieties."( The metabolism of mebeverine in man: identification of urinary metabolites by gas chromatography/mass spectrometry.
Jóhannsson, M; Kristinsson, J; Snorradóttir, I, 1994
)
1.34
"Mebeverine acid appears to be a valuable marker of oral exposure to mebeverine."( Identification of mebeverine acid as the main circulating metabolite of mebeverine in man.
de Vos, D; Guelen, PJ; Stockis, A, 2002
)
1.37

Toxicity

ExcerptReferenceRelevance
" Very few adverse events were noted and a causal relationship with the study medications was judged as improbable or definitely unrelated."( A double-blind crossover comparison study of the safety and efficacy of mebeverine with mebeverine sustained release in the treatment of irritable bowel syndrome.
Ceuppens, M; Hendrickx, B; Mayeur, S; Meeus, MA; Rosillon, D; Van Outryve, M, 1995
)
0.52

Pharmacokinetics

ExcerptReferenceRelevance
"This study was conducted to compare the pharmacokinetic properties of the modified release 200 mg capsule of mebeverine and the plain 135 mg tablet of mebeverine after single and multiple doses in 12 healthy subjects in a randomised, crossover design."( A pharmacokinetic comparison of the modified release capsule and a plain tablet formulation of mebeverine.
Boon, C; Brekle, A; de Vries, M; Meuwsen, IM; van der Laan, A; Winsemius, A, 2002
)
0.75
" The pharmacokinetic studies showed that the mean plasma levels of (+)-MEB were higher than those of (-)-MEB at almost all time points."( Fiber-based liquid-phase micro-extraction of mebeverine enantiomers followed by chiral high-performance liquid chromatography analysis and its application to pharmacokinetics study in rat plasma.
Farhadi, K; Hatami, M; Tukmechi, A, 2012
)
0.64
" In addition, to further confirm the solubilizing effect of Tween 80, a pharmacokinetic study of ferulic acid (FA) in rats after oral administration of OZ 100 mg/kg under combined use of Tween 80 though LCMS/MS was carried out."( Pharmacokinetics study of ferulic acid in rats after oral administration of γ-oryzanol under combined use of Tween 80 by LC/MS/MS.
Cai, L; He, S; Pan, Y; Zhang, Z, 2014
)
0.4
" The values of T1/2Ka, AUC0-∞, MRT0-t, and Tmax showed up to increase 16%, 58%, 44% and 47% while Cmax and CL/F decreased 22% and 12%, respectively."( Pharmacokinetics study of ferulic acid in rats after oral administration of γ-oryzanol under combined use of Tween 80 by LC/MS/MS.
Cai, L; He, S; Pan, Y; Zhang, Z, 2014
)
0.4

Compound-Compound Interactions

ExcerptReferenceRelevance
"HPLC fingerprint analysis combined with chemometrics was developed to discriminate between the red and the white rice bran grown in Indonesia."( Discrimination of red and white rice bran from Indonesia using HPLC fingerprint analysis combined with chemometrics.
Darusman, LK; Rafi, M; Sabir, A, 2017
)
0.46
"Alkaline treatment (Alk) combined with ultrasound-assisted extraction (UAE) (Alk+UAE) was examined as a means of extracting tocols and γ-oryzanol from rice bran into an organic phase while simultaneously recovering ferulic acid into an aqueous phase."( Binary Solvent Extraction of Tocols, γ-Oryzanol, and Ferulic Acid from Rice Bran Using Alkaline Treatment Combined with Ultrasonication.
Boi, LV; Imamura, K; Luu, PD; Maeda, Y; Matsubara, T; Takahashi, H; Takenaka, N; Truong, HT, 2017
)
0.46

Bioavailability

ExcerptReferenceRelevance
" In the present study, human volunteers were pretreated with pyridostigmine to attempt to improve the bioavailability of the parent drug."( Lack of bioavailability of mebeverine even after pretreatment with pyridostigmine.
Eloff, JN; Snyman, JR; Sommers, DK; van Wyk, M, 1997
)
0.59
" The 200 mg modified release capsule of mebeverine has extended release properties, as indicated by a lower Cmax, a later tmax and a longer elimination half-life than the plain tablet, while the bioavailability is optimal."( A pharmacokinetic comparison of the modified release capsule and a plain tablet formulation of mebeverine.
Boon, C; Brekle, A; de Vries, M; Meuwsen, IM; van der Laan, A; Winsemius, A, 2002
)
0.8
" Furthermore, current water quality monitoring does not differentiate between soluble and colloidal phases in water samples, hindering our understanding of the bioavailability and bioaccumulation of pharmaceuticals in aquatic organisms."( Colloids as a sink for certain pharmaceuticals in the aquatic environment.
Maskaoui, K; Zhou, JL, 2010
)
0.36
" Such strong pharmaceutical/colloid interactions may provide a long-term storage of pharmaceuticals, hence, increasing their persistence while reducing their bioavailability in the environment."( Colloids as a sink for certain pharmaceuticals in the aquatic environment.
Maskaoui, K; Zhou, JL, 2010
)
0.36
" As aquatic colloids are abundant, ubiquitous, and highly powerful sorbents, they are expected to influence the bioavailability and bioaccumulation of such chemicals by aquatic organisms."( Colloids as a sink for certain pharmaceuticals in the aquatic environment.
Maskaoui, K; Zhou, JL, 2010
)
0.36
" Otilonium bromide is poorly absorbed from the GI tract, where it acts locally as an L-type calcium channel blocker, an antimuscarinic and a tachykinin NK2 receptor antagonist."( Role of antispasmodics in the treatment of irritable bowel syndrome.
Annaházi, A; Róka, R; Rosztóczy, A; Wittmann, T, 2014
)
0.4
" In vivo release study of OZ, physically entrapped within chitosan-coated CP microcapsules, demonstrated the sustained release of OZ and could be used to improve the bioavailability of OZ following oral administration."( Optimization, in vitro release and bioavailability of gamma-oryzanol-loaded calcium pectinate microparticles reinforced with chitosan.
Chang, PS; Kim, JS; Lee, HG; Lee, JS, 2010
)
0.36
"Our results reveal that Tween 80 improves solubility of OZ in vitro and could enhance the bioavailability of OZ by extending its absorption and elimination."( Pharmacokinetics study of ferulic acid in rats after oral administration of γ-oryzanol under combined use of Tween 80 by LC/MS/MS.
Cai, L; He, S; Pan, Y; Zhang, Z, 2014
)
0.4
" Taking into account the bioavailability of these compounds, it is evident that a number of factors affect the antioxidant composition of rice, making it difficult to estimate dietary intake."( Factors influencing antioxidant compounds in rice.
Goufo, P; Trindade, H, 2017
)
0.46
" Therefore, in this study, to overcome extremely low bioavailability of γ-oryzanol with super-high lipophilicity, we encapsulated γ-oryzanol in polymer poly (DL-lactide-co-glycolide) (PLGA) nanoparticles (Nano-Orz), and evaluated its metabolically beneficial impact in genetically obese-diabetic ob/ob mice, the best-known severest diabetic model in mice."( Marked augmentation of PLGA nanoparticle-induced metabolically beneficial impact of γ-oryzanol on fuel dyshomeostasis in genetically obese-diabetic ob/ob mice.
Abe, K; Egashira, K; Fukuda, K; Kamei, A; Kinjo, A; Kondo, T; Kozuka, C; Masuzaki, H; Morinaga, H; Nakano, K; Shimizu-Okabe, C; Takayama, C; Yasuoka, A, 2017
)
0.46
" However, the incorporation of γ-oryzanol into aqueous formulations is rather difficult and its bioavailability can be severely decreased because of its water-insoluble property."( γ-Oryzanol nanoemulsions produced by a low-energy emulsification method: an evaluation of process parameters and physicochemical stability.
Li, Z; Liu, X; Qin, X; Wang, Y; Zhong, J, 2017
)
0.46
" This fact evidence that oryzanol is not a bioavailability fraction, while phenolic compounds support to some extent, the conditions of digestion."( Bioavailability, composition and functional characterization of extracts from Oryza sativa L. bran.
Ayuso-Yuste, MC; Delgado-Adámez, J; Gil, MV; Manzano-Durán, R; Martillanes, S, 2018
)
0.48
"Self-emulsion improves solubility and bioavailability for γ-oryzanol/algae oil, and alginate beads can be used as controlled release carriers."( Preparation and Evaluation of Release Formulation of γ-Oryzanol/Algae Oil Self-Emulsified with Alginate Beads.
Chiang, PY; Yang, KM, 2019
)
0.51
" Collectively, these results may have important implications in designing oleogel systems with controlled lipid digestibility as well as controlling the bioavailability of delivered lipid-soluble bioactive compounds."(
Cao, Y; Dong, L; Gao, X; Lan, Y; Lv, M; Rogers, M; Zhang, L, 2020
)
0.56

Dosage Studied

Mebeverine, in the initial dosing period, has a normalizing effect in the small bowel in IBS. It enhances contractile activity in a similar fashion to 'prokinetic' agents.

ExcerptRelevanceReference
"001) more effective than placebo, but not significantly so when the dosage level was halved."( A three-part controlled study of trimebutine in the treatment of irritable colon syndrome.
Lüttecke, K, 1980
)
0.26
"These findings suggest that mebeverine, in the initial dosing period, has a normalizing effect in the small bowel in IBS, enhancing contractile activity in a similar fashion to 'prokinetic' agents, as well as producing alterations in motor activity consistent with an 'antispasmodic' effect."( Mebeverine alters small bowel motility in irritable bowel syndrome.
Bak, YT; Evans, PR; Kellow, JE, 1996
)
2.03
" The urinary excretion of mebeverine acid within the first 4 h after dosing amounted to 67% of the mebeverine dose (median range: 23-107%)."( Identification of mebeverine acid as the main circulating metabolite of mebeverine in man.
de Vos, D; Guelen, PJ; Stockis, A, 2002
)
0.95
" The twice-daily dosage regimen of the 200 mg modified release capsule is a good alternative to the three times daily dosage regimen of the 135 mg plain tablet, because the reduced daily intake is likely to benefit patient compliance."( A pharmacokinetic comparison of the modified release capsule and a plain tablet formulation of mebeverine.
Boon, C; Brekle, A; de Vries, M; Meuwsen, IM; van der Laan, A; Winsemius, A, 2002
)
0.53
" All of the patients underwent the monotherapy with Mebeverine Retard in the dosage of 200 mg twice a day."( [Duspatalin in functional disorders of the Oddi's sphincter in patients subjected cholecystectomy].
Bystrovskaia, EV; Il'chenko, AA, 2002
)
0.57
" The proposed method was applied for analysis of mebeverine in commercially available tablets dosage formulations."( A validated chiral HPLC method for the determination of mebeverine HCl enantiomers in pharmaceutical dosage forms and spiked rat plasma.
Abdine, HH; Aboul-Enein, HY; Radwan, MA, 2006
)
0.83
" The validated HPLC methods were successfully applied to the analysis of their commercial tablet dosage forms, for which no interfering peaks were encountered from common pharmaceutical adjuvants."( Validated HPLC determination of the two fixed dose combinations (chlordiazepoxide hydrochloride and mebeverine hydrochloride; carvedilol and hydrochlorothiazide) in their tablets.
Belal, TS; Haggag, RS; Shaalan, RA,
)
0.35
"An HPLC method for the quantitative analysis of mebeverine HCl, 5-aminosalicylic acid (5-ASA), sulphasalazine and dispersible aspirin has been developed and then applied to these specific medicines when stored, with other medications, in Venalink blister packs (monitored dosage system) for periods of up to 35 days."( Quantitative HPLC analysis of mebeverine, mesalazine, sulphasalazine and dispersible aspirin stored in a Venalink monitored dosage system with co-prescribed medicines.
Blagbrough, IS; Elmasry, MS; Kheir, AA; Rogers, PJ; Rowan, MG; Saleh, HM, 2011
)
0.91
" To project the comparison in a sensible way, the methods are used for the stability indicating quantitative analysis of mixtures of mebeverine hydrochloride and sulpiride in binary mixtures as a case study in presence of their reported impurities and degradation products (summing up to 6 components) in raw materials and pharmaceutical dosage form via handling the UV spectral data."( Support vector regression and artificial neural network models for stability indicating analysis of mebeverine hydrochloride and sulpiride mixtures in pharmaceutical preparation: a comparative study.
Darwish, HW; Naguib, IA, 2012
)
0.8
" The developed spectrophotometric methods depend on determination of MEH and DF in the combined dosage form using the successive derivative ratio spectra method which depends on derivatization of the obtained ratio spectra in two steps using methanol as a solvent and measuring MEH at 226."( Validated chromatographic and spectrophotometric methods for analysis of some amoebicide drugs in their combined pharmaceutical preparation.
Abdelaleem, EA; Abdelwahab, NS, 2013
)
0.39
" The specificity of the developed methods was investigated by analyzing the laboratory mixtures and was successfully applied for their combined dosage form."( Simultaneous determination of mebeverine hydrochloride and chlordiazepoxide in their binary mixture using novel univariate spectrophotometric methods via different manipulation pathways.
Fayez, YM; Lotfy, HM; Michael, AM; Nessim, CK, 2016
)
0.72
" The dosage and usage of western medication were same as those in the western medication group; and acupoints in acupuncture treatment were same as those in the acupuncture group."( [Senile insomnia treated with integrated acupuncture and medication therapy: a randomized controlled trial].
Wang, J; Wang, L; Zhang, Y, 2015
)
0.42
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Occurs in Manufacturing (2 Product(s))

Product Categories

Product CategoryProducts
Vitamins & Supplements2

Products

ProductBrandCategoryCompounds Matched from IngredientsDate Retrieved
Bio Nutrition Testosterone Wellness for Men -- 60 TabletsBio NutritionVitamins & SupplementsVitamin E, DHEA, Gamma Oryzanol, Vitamin E, Gamma Oryzanol2024-11-29 10:47:42
Futurebiotics EstroComfort™ -- 56 Vegetarian CapsulesFuturebioticsVitamins & SupplementsFolic Acid, Gamma Oryzanol, Gamma Oryzanol, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42

Drug Classes (1)

ClassDescription
methoxybenzoic acidAny benzoic acid carrying one or more methoxy substituents.
[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]

Bioassays (5)

Assay IDTitleYearJournalArticle
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID57170Antispasmodic activity was measured on colonic contraction in anesthetized dog after iv administration of a dose of 0.1 mg/kg1982Journal of medicinal chemistry, Nov, Volume: 25, Issue:11
Spasmolytic agents. 2. 1,2,3,4-Tetrahydro-2-naphthylamine derivatives.
AID57171Antispasmodic activity was measured on stomach contraction in anesthetized dog after iv administration of a dose of 0.1 mg/kg1982Journal of medicinal chemistry, Nov, Volume: 25, Issue:11
Spasmolytic agents. 2. 1,2,3,4-Tetrahydro-2-naphthylamine derivatives.
AID768229Inhibition of C-terminal FLAG-tagged human recombinant autotaxin using synthetic substrate FS-3 at 10 uM measured every 2 mins by FRET assay relative to control2013Bioorganic & medicinal chemistry, Sep-01, Volume: 21, Issue:17
Autotaxin inhibition: development and application of computational tools to identify site-selective lead compounds.
AID311932Inhibition of ASM in human H4 cells assessed as residual activity at 10 uM2008Journal of medicinal chemistry, Jan-24, Volume: 51, Issue:2
Identification of new functional inhibitors of acid sphingomyelinase using a structure-property-activity relation model.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (429)

TimeframeStudies, This Drug (%)All Drugs %
pre-199042 (9.79)18.7374
1990's39 (9.09)18.2507
2000's78 (18.18)29.6817
2010's205 (47.79)24.3611
2020's65 (15.15)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 102.66

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index102.66 (24.57)
Research Supply Index5.23 (2.92)
Research Growth Index4.72 (4.65)
Search Engine Demand Index190.54 (26.88)
Search Engine Supply Index2.06 (0.95)

This Compound (102.66)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials48 (34.78%)5.53%
Trials11 (3.58%)5.53%
Reviews9 (6.52%)6.00%
Reviews26 (8.47%)6.00%
Case Studies4 (2.90%)4.05%
Case Studies0 (0.00%)4.05%
Observational2 (1.45%)0.25%
Observational0 (0.00%)0.25%
Other75 (54.35%)84.16%
Other270 (87.95%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (12)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
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
Management of Irritable Bowel Syndrome in Primary Care: Feasibility Randomised Controlled Trial of Mebeverine, Methylcellulose, Placebo and a Patient Self-management Cognitive Behavioural Therapy Website. (MIBS Trial) [NCT00934973]Phase 4135 participants (Actual)Interventional2010-04-30Completed
A Comparative Study to Assess Safety and Effectiveness of Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome [NCT04217733]Phase 360 participants (Anticipated)Interventional2019-11-01Recruiting
Multicenter Randomized Controlled Clinical Trial Comparing Ebastine and Mebeverine as Treatment of Irritable Bowel Syndrome [NCT05815602]Phase 3200 participants (Anticipated)Interventional2023-03-30Recruiting
Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome. a 4-Week, Multicentre, Double-Blind, Randomised, Placebo-Controlled Phase IV Trial [NCT00542295]Phase 4400 participants (Anticipated)Interventional2007-07-31Completed
Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute. A Randomised Controlled Trial [NCT04635566]120 participants (Actual)Interventional2019-03-01Completed
Mebeverine For Daytime And Nocturnal Incontinence and After Orthotopic W-Ileal Neobladders - Assessment Of Efficacy And Quality Of Life Effect Within 1 Year Post-Surgery: A Randomized Controlled Study [NCT03147599]Phase 4110 participants (Actual)Interventional2017-05-15Completed
To Compare the Efficacy of (Rifaximin + Mebeverine), (Rifaximin + Amitriptyline), and (Rifaximin + Psyllium Husk) in Irritable Bowel Syndrome Associated With Diarrhea [NCT05867550]Phase 4162 participants (Actual)Interventional2023-01-03Completed
Effectiveness of Duspatalin® (Mebeverine Hydrochloride) 200 mg b.i.d. in Patients With Post-cholecystectomy Gastrointestinal Spasm: a Post Marketing Observational Program in the Russian Federation [NCT02260154]220 participants (Actual)Observational2015-07-31Completed
The Instant Efficacy and Safety of Alverine in Decreasing Portal Hypertension: an Exploratory Pilot Study [NCT05508633]Phase 220 participants (Anticipated)Interventional2022-08-31Not yet recruiting
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
Assessment of On-demand MeteoSpasmyl® Use Effectiveness in Irritable Bowel Syndrome [NCT01404923]Phase 4436 participants (Actual)Interventional2009-12-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT01404923 (2) [back to overview]Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score
NCT01404923 (2) [back to overview]Percentage of Improvement of the Total IBSQoL Scores
NCT02260154 (11) [back to overview]"Percentage of Responders to Duspatalin® Therapy"
NCT02260154 (11) [back to overview]Health Economics Data 3
NCT02260154 (11) [back to overview]Healths Economic Data 2
NCT02260154 (11) [back to overview]"Percentage of Responders to Duspatalin® Therapy"
NCT02260154 (11) [back to overview]Changes in Abdominal Pain
NCT02260154 (11) [back to overview]Changes in Dyspepsia Symptoms
NCT02260154 (11) [back to overview]Changes in Quality of Life
NCT02260154 (11) [back to overview]Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form
NCT02260154 (11) [back to overview]Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form 2
NCT02260154 (11) [back to overview]Health Economic Data
NCT02260154 (11) [back to overview]Reasons for Continuing Treatment Beyond 2 Weeks

Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score

Irritable Bowel Syndrome Quality of Life total score (IBSQoL) is a health-related Quality of Life (QoL) disease-specific scale adapted for French patients. Total score ranges from minimum=0 to maximum = 100 representing the best outcome. (NCT01404923)
Timeframe: Baseline and 6 months

Interventionunits on a scale (Mean)
Meteospasmyl13.8
Standard of Care8.4

[back to top]

Percentage of Improvement of the Total IBSQoL Scores

Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage (NCT01404923)
Timeframe: Baseline and 6 Months

Intervention% of improvement of IBSQoL total scores (Mean)
Meteospasmyl28.5
Standard of Care18.6

[back to top]

"Percentage of Responders to Duspatalin® Therapy"

(NCT02260154)
Timeframe: Up to 6 weeks

Interventionpercentage of participants (Number)
Post-cholecystectomy Gastrointestinal Spasms79.0

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Health Economics Data 3

Number of days missed from work for currently employed subjects. Change is calculated as Week 6 value minus Baseline value. Negative change means less number of days missed from work. (NCT02260154)
Timeframe: change from baseline at Week 6

InterventionNumber of days (Mean)
Post-cholecystectomy Gastrointestinal Spasms-2.1

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Healths Economic Data 2

Number of visits to clinic for currently employed subjects. Change is calculated as Week 6 value minus Baseline value. Negative change means less number of visits to clinic. (NCT02260154)
Timeframe: from baseline at Week 6

Interventionnumber of visits (Mean)
Post-cholecystectomy Gastrointestinal Spasms-0.9

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"Percentage of Responders to Duspatalin® Therapy"

Patients indicating being 'symptom-free' or 'markedly improved'on Global Patient Assessment (NCT02260154)
Timeframe: 2 weeks

Interventionpercentage of participants (Number)
Symptom-free or markedly improvedOther values (slightly improved, unchanged, worse)
Post-cholecystectomy Gastrointestinal Spasms63.636.4

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Changes in Abdominal Pain

Measured by 11-items Numerous Rating Scale where 0 represents no pain and 10 represents the worst pain. Negative change corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value. (NCT02260154)
Timeframe: Baseline, 2 weeks and up to 6 weeks

Interventionunits on a scale (Mean)
change from baseline at Week 2change from baseline at Week 6
Post-cholecystectomy Gastrointestinal Spasms-3.7-4.4

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Changes in Dyspepsia Symptoms

Measured by 11-items Numerous Rating Scale where 0 represents no symptoms and 10 represents the worst symptoms. Negative change corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value. (NCT02260154)
Timeframe: Baseline, 2 weeks and up to 6 weeks

Interventionunits on a scale (Mean)
change from baseline at Week 2change from baseline at Week 6
Post-cholecystectomy Gastrointestinal Spasms-2.0-2.3

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Changes in Quality of Life

Gastrointestinal Quality of Life Index contains 36 questions with 4 possible answers per each (most desirable option returns 4 points, and least desirable option returns 0 points). Total score of the GIQLI is calculated as sum of all items. The source scores are transformed and scaled from 0 to 100. The high score corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value. (NCT02260154)
Timeframe: Baseline, 2 weeks and up to 6 weeks

Interventionunits on a scale (Mean)
change from baseline at Week 2change from baseline at Week 6
Post-cholecystectomy Gastrointestinal Spasms16.80221.737

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Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form

"Changes in Stool Habits: The change is presented as the proportion of patients whose Changes in Stool Habits from 'Abnormal' to 'Normal' and vice versa were registered. Positive is defined as Change from 'Abnormal stool form at BL' to 'Normal stool form at Week 2'. Negative is defined as Change from 'Normal stool form at BL' to 'Abnormal stool form at Week 2'." (NCT02260154)
Timeframe: Baseline to Week 2

Interventionpercentage of participants (Number)
PositiveNegative
Post-cholecystectomy Gastrointestinal Spasms38.252.30

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Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form 2

"Changes in Stool Habits: The change is presented as the proportion of patients whose Changes in Stool Habits from 'Abnormal' to 'Normal' and vice versa were registered. Positive is defined as Change from 'Abnormal stool form at BL' to 'Normal stool form at Week 6'. Negative is defined as Change from 'Normal stool form at BL' to 'Abnormal stool form at Week 6'." (NCT02260154)
Timeframe: Baseline to Week 6

Interventionpercentage of participants (Number)
PositiveNegative
Post-cholecystectomy Gastrointestinal Spasms40.002.00

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Health Economic Data

Relevant concomitant medication (NCT02260154)
Timeframe: Baseline, up to 6 weeks

Interventionpercentage of participants (Number)
ACE inhibitorsAlpha adrenoreceptor antagonistAluminium compoundsAngiotensine II antagonistAnti arrhythmicsAnti diarrhealAnti inflammatoryBarbituratesBeta blocking against agents, selectiveBiguanigesBile acid preparationsBioflavonoidsBlood transfusion, auxilary productsBeta blocking agents, and other antihypertensivesBeta blocking agents, thiazides
Post-cholecystectomy Gastrointestinal Spasms9.60.52.31.40.51.40.50.54.10.910.10.50.50.50.5

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Reasons for Continuing Treatment Beyond 2 Weeks

List and rate of reasons (NCT02260154)
Timeframe: 2 weeks

Interventionpercentage of participants (Number)
Expectation in higher effectivenessTend to treat beyond 2 weeksMaintenance of achieved effect
Post-cholecystectomy Gastrointestinal Spasms84.24.011.9

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