Upper gastrointestinal system endoscopy is widely used for diagnostic approach. To increase the tolerability and compliance of the patient, sedation is applied. There are many studies showing that sedation increases the patient compliance and the tolerability. However, spasmolytic use in GE has not been evaluated yet.

Start Date01 Jan 2013

Sponsor / Collaborator

Konya Meram State Hospital

EUCTR2005-001655-38-BE

/ Not yet recruitingNot ApplicableIIT

Otilonium Bromide in Irritable Bowel Syndrome – (OBIS)Double blind, randomized, parallel group, placebo-controlled study to evaluate the effect of otilonium bromide on abdominal pain and quality of life in patients with irritable bowel syndrome Barostat sub-study:Effect of otilonium bromide versus placebo on the perception of rectal distension in patients with irritable bowel syndrome (IBS).

Start Date06 Mar 2006

Sponsor / Collaborator-

100 Clinical Results associated with Otilonium Bromide

100 Translational Medicine associated with Otilonium Bromide

100 Patents (Medical) associated with Otilonium Bromide

139

Literatures (Medical) associated with Otilonium Bromide

30 Oct 2025·Journal of Neurogastroenterology and Motility

Treatment of Irritable Bowel Syndrome With Antispasmolytics in Taiwan, Hong Kong, and Vietnam: A Delphi Expert Consensus Statement

Article

Author: Mehta, Radhika ; Wang, Shan ; Tadwalkar, Swarali ; Burr, Benjamin ; Hashim, Sabera ; Gupta, Ankur

Background/Aims:

In Hong Kong, Taiwan and Vietnam, the burden of irritable bowel syndrome (IBS) is poorly documented, with limited evidence-based treatments and outdated guidelines. We used a modified Delphi method to reach expert consensus on different aspects of disease management and gain insights into the current clinical practice for IBS in these 3 countries, focusing on treatment with antispasmolytics.

Methods:

Evidence from a targeted literature review was used to draft consensus statements for a multidisciplinary 3-round Delphi survey. Consensus was defined as ≥ 70% agreement among experts from the same country (qualitative data) or a SD < 5% on rate estimates (quantitative data). Data were grouped and analyzed by expert specialty and country.

Results:

Thirty-six experts (12 per country; primary care physicians, n = 6; gastroenterologists, n = 4; and pharmacists, n = 2) participated in the 3 voting rounds. Consensus was reached for 17/25 (68.0%) statements. Respondents agreed that IBS diagnosis relies on symptoms and guidelines. Regarding antispasmolytics, most experts were highly satisfied with the available medications, particularly hyoscine and otilonium bromide, and agreed on a short (< 2 weeks) treatment duration. Mean 1-year relapse rate was 38.3-48.0% with antispasmolytics overall and 20.5-26.5% with otilonium bromide. In all 3 countries, consensus was reached that frequent IBS relapses affect patients' daily routine and quality of life frequently and that long-term treatment strategies addressing relapse represent a key unmet need in IBS management.

Conclusions:

Although antispasmolytics provide immediate symptom relief, their long-term effectiveness needs further investigations in Asian populations. Our findings may inform clinical decision-making and guideline updates.

19 Aug 2025·ACS Omega

Effect of Source and Degree of Esterification of High Methoxyl Pectin on Oral Colon-Targeted Multiparticulated Delivery of Otilonium Bromide

Article

Author: Mittal, Ashu ; Ghosh, Debaprasad ; Arora, Mandeep Kumar

This study aims to evaluate HM (high methoxyl) pectin from different sources (apple, citrus, and beet) with varying degrees of methyl esterification (DOE) to identify the optimal grade for colonic bacterial enzyme-triggered polymeric coatings for colon-targeted delivery of drugs. Drug-loaded multiparticulates were prepared by a powder layering technique and subsequently coated into distinct trial formulation batches with ethyl cellulose and different HM pectin-based plasticized coating solutions. Otilonium bromide, a model drug for irritable bowel syndrome, was employed. Drug-polymer compatibility was confirmed through FT-IR and DSC studies. The coated multiparticulates demonstrated high drug entrapment efficiency (>85%), favorable micromeritic properties, and minimal loose surface drug crystals (<1.2%). Among the batches, F₄₈ (p = 0.0042), coated with apple pectin (DOE 50%), exhibited superior colon-targeting efficiency, limiting drug release to 15.47 ± 1.53% under simulated upper gastrointestinal conditions while achieving 78.27 ± 2.11% release under colonic conditions by the ninth hour in vitro. Surface topography was analyzed via scanning electron microscopy before and after dissolution. In vivo, X-ray roentgenography, and gamma-scintigraphy studies in New Zealand white rabbits further validated the colon-targeting efficacy of the optimized batch. The source and DOE value of the HM pectin were found to affect premature drug release and colon-targeting efficiency. Apple HM pectin 50% DOE was found to be the ideal HM pectin for microbial enzyme-dependent colon-targeted coatings.

01 Jun 2025·Clinical Gastroenterology and Hepatology

Functional Variation in Human CAZyme Genes in Relation to the Efficacy of a Carbohydrate-Restricted Diet in IBS Patients

Article

Author: D'Amato, Mauro ; Mayr, Gabriele ; Blanco, Cristina Esteban ; Löscher, Britt-Sabina ; Esteban Blanco, Cristina ; Bonfiglio, Ferdinando ; Van den Houte, Karen ; Hoter, Abdullah ; Bozzarelli, Isotta ; Naim, Hassan Y ; Naim, Hassan Y. ; Franke, Andre ; Tack, Jan ; Zamfir-Taranu, Andreea ; Torices, Leire ; Routhiaux, Karen ; Carbone, Florencia ; Corsetti, Maura ; D’Amato, Mauro

BACKGROUND & AIMS:

Limiting the dietary intake of certain carbohydrates has therapeutic effects in some but not all irritable bowel syndrome (IBS) patients. We investigated genetic variation in human Carbohydrate-Active enZYmes (hCAZymes) genes in relationship to the response to a FODMAP-lowering diet in the DOMINO study.

METHODS:

hCAZy polymorphism was studied in patients with IBS from the dietary (FODMAP-lowering; n = 196) and medication (otilonium bromide; n = 54) arms of the DOMINO trial via targeted sequencing of 6 genes of interest (AMY2B, LCT, MGAM, MGAM2, SI, and TREH). hCAZyme defective (hypomorphic) variants were identified via computational annotation using clinical pathogenicity classifiers. Age- and sex-adjusted logistic regression was used to test hCAZyme polymorphisms in cumulative analyses where IBS patients were stratified into carrier and non-carrier groups (collapsing all hCAZyme hypomorphic variants into a single bin). Quantitative analysis of hCAZyme variation was also performed, in which the number of hCAZyme genes affected by a hypomorphic variant was taken into account.

RESULTS:

In the dietary arm, the number of hypomorphic hCAZyme genes positively correlated with treatment response rate (P = .03; odds ratio = 1.51; confidence interval = 0.99-2.32). In the IBS-D group (n = 55), hCAZyme carriers were 6 times more likely to respond to the diet than non-carriers (P = .002; odds ratio = 6.33; confidence interval = 1.83-24.77). These trends were not observed in the medication arm.

CONCLUSIONS:

hCAZYme genetic variation may be relevant to the efficacy of a carbohydrate-lowering diet. This warrants additional testing and replication of findings, including mechanistic investigations of this phenomenon.

News (Medical) associated with Otilonium Bromide

25 Sep 2023

·www.pharmaindustrial-india.com

Lupin Acquires Five Brands from Menarini

Global pharma major Lupin Limited (Lupin) announced today that it has signed an agreement to acquire five legacy brands in strategic therapy areas - Gastroenterology, Urology and Anti-infectives from Menarini (A. Menarini India Private Limited and A. Menarini Asia-Pacific Holdings Pte. Ltd.), along with the associated trademark rights. The brands are Piclin (Picosulphate Sodium), Menoctyl (Otilonium Bromide), Sucramal O (Sucralfate + Oxetacaine), Pyridium (Phenazopyridine) and Distaclor (Cefaclor). Lupin has been exclusively marketing these brands in the Indian market since July 2021 under a distribution and promotion agreement with A. Menarini India Private Limited. This strategic acquisition for the Indian market marks a significant step forward for Lupin as it continues to expand its presence in India. These legacy brands help Lupin in further enhancing its diverse portfolio and solidifying its position as a leading pharmaceutical organization in India. Commenting on the acquisition, Nilesh Gupta, Managing Director, Lupin said, “This acquisition aligns well with our strategic goal to broaden our presence in the Indian market. By offering a comprehensive range of products, our aim is to deliver even greater value to our stakeholders and the communities we serve.” “Growing urbanization and dietary changes are driving the demand for gastrointestinal and urology treatments in India,” said Rajeev Sibal, President – India Region Formulations, Lupin. “This acquisition strengthens our presence in India and bolsters our therapy pipeline. At Lupin, we are committed to empowering healthcare professionals in managing the increasing disease burden and improving the lives of patients significantly.” “Lupin has been successfully marketing the scope brands for Menarini since 2021, which has been a testament to our evolved collaboration. I am happy that Lupin will now carry forward their legacy with full trademark ownership. For Menarini, this transaction further signals our continued commitment to nurture and expand our Dermatology and Aesthetics portfolio and business. Menarini is a top 10 multi-national company in this therapeutic area in India and has witnessed strong organic and inorganic growth,” said Girisan Kariangal, Managing Director – Menarini India.

Acquisition

100 Deals associated with Otilonium Bromide

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KEGG	Wiki	ATC	Drug Bank
D07083	Otilonium Bromide	A03AB06	DBSALT002518

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Indication	Country/Location	Organization	Date
Gastrointestinal Diseases	China	A. Menarini Industrie Farmaceutiche Riunite Srl	-
Spasm	China	A. Menarini Industrie Farmaceutiche Riunite Srl	-

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