Delving into the Latest Updates on Itopride Hydrochloride with Synapse

主要研究目的研究空腹和餐后状态下单次口服受试制剂盐酸伊托必利片（规格：50 mg，裕松源药业有限公司生产）与参比制剂盐酸伊托必利片（商品名为力苏®，规格：50 mg，ABBOTT LABORATORIES(M) SDN.BHD持证）在健康成年受试者体内的药代动力学，比较受试制剂和参比制剂药代动力学的差异，同时计算主要药动学参数（Cmax、AUC0-t和AUC0-∞），并进行初步比较。次要研究目的评价健康受试者在空腹和餐后状态下，单次口服盐酸伊托必利片受试制剂和参比制剂后的安全性。

[Translation]

Main study objectives To study the pharmacokinetics of the test preparation itopride hydrochloride tablets (specification: 50 mg, produced by Yusongyuan Pharmaceutical Co., Ltd.) and the reference preparation itopride hydrochloride tablets (trade name Lisu®, specification: 50 mg, ABBOTT LABORATORIES(M) SDN.BHD) in healthy adult subjects after a single oral administration in the fasting and fed state, to compare the differences in pharmacokinetics between the test preparation and the reference preparation, and to calculate the main pharmacokinetic parameters (Cmax, AUC0-t and AUC0-∞), and make a preliminary comparison. Secondary study objectives To evaluate the safety of the test preparation and the reference preparation of itopride hydrochloride tablets after a single oral administration in healthy subjects in the fasting and fed state.

Start Date26 Jun 2024

Sponsor / Collaborator

Yusongyuan Pharmaceutical Co. Ltd.

NCT06217393 / RecruitingPhase 3

Randomized Multicentre Open-label Study to Investigate the Non-inferiority of Itopride Hydrochloride 150mg Once Daily Versus Itopride Hydrochloride 50 mg Thrice Daily in Subjects With Functional (Non-ulcer) Dyspepsia or Chronic Gastritis

The study is conducted in patients with functional dyspepsia or chronic gastritis. The purpose of this study is to:
assess whether the dose of Itopride Hydrochloride 150 mg extended release tablets, taken once daily has a similar effect on gastrointestinal symptoms caused by gastric dysmotility and delayed gastric emptying, like bloating sensation, early satiety, postprandial fullness, upper abdominal pain or discomfort, anorexia, heartburn, nausea and vomiting in functional (non-ulcer) dyspepsia or chronic gastritis, as Itopride Hydrochloride 50 mg film coated tablets administered thrice a day.
investigate assessment of the treatment provided to each participant.
monitor safety and tolerability of Itopride Hydrochloride 150 mg extended release tablets, taken once daily before one of the main meals (preferably same meal throughout the treatment) and Itopride Hydrochloride 50 mg film coated tablets thrice daily before meals.

Start Date28 Feb 2024

Sponsor / Collaborator

Abbott Laboratories

100 Clinical Results associated with Itopride Hydrochloride

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100 Translational Medicine associated with Itopride Hydrochloride

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100 Patents (Medical) associated with Itopride Hydrochloride

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163

Literatures (Medical) associated with Itopride Hydrochloride

01 Sep 2024·Respiratory Investigation

Gastroesophageal reflux disease in chronic obstructive pulmonary disease

Review

Author: Muro, Shigeo ; Tanimura, Kazuya

Gastroesophageal reflux disease (GERD) is one of the most common comorbidities of chronic obstructive pulmonary disease (COPD). Decreased lower and upper esophageal sphincter pressures, esophageal dysmotility, high transdiaphragmatic pressure, and decreased saliva secretion have been implicated as mechanisms leading to the development of GERD in COPD. Clinically, comorbid GERD in COPD is reportedly associated with worse symptoms, quality of life, and lung function, as well as a high risk of exacerbations. Aspiration of regurgitation and the cholinergic-mediated esophagobronchial reflex play a significant role in the pathophysiology. Abnormal swallowing reflexes and discoordination of swallowing can worsen aspiration. The diagnosis of GERD is not based on a single criterion; however, various approaches, including questionnaires and endoscopic evaluations, can be widely applied in clinical settings. Due to the increased risk of esophageal and gastric cancers in patients with COPD, the threshold for endoscopic examination should be low. Acid inhibitory agents, such as proton pump inhibitors and histamine H2 receptor antagonists, and prokinetic agents, including mosapride and itopride, are clinically used to treat GERD. Endoscopic fundoplication can be performed in patients with GERD refractory to medical treatment. There is still insufficient evidence, but an increasing number of studies have suggested the clinical efficacy of treatment in patients with COPD and GERD. As GERD is an evaluative and treatable common disease, and access to evaluation and treatment is relatively easy, clinicians should provide adequate care for GERD in the management of COPD.

01 Feb 2024·JGH Open

Efficacy and safety of pantoprazole and itopride in patients with overlap of gastroesophageal reflux disease and dyspepsia: A prospective, open‐label, single‐arm pilot study

Article

Author: Singh, Aniruddha P ; Memon, Sana F ; Reddy, Duvvur N ; Lakhtakia, Sundeep ; Singla, Neeraj

AbstractBackground and AimCombining proton pump inhibitors (PPIs) with prokinetics can provide synergistic action in patients with gastroesophageal reflux disease (GERD) and overlapping dyspepsia, but data regarding this is lacking.MethodsThis single‐center, prospective study evaluated the efficacy and safety of 6‐week treatment with fixed‐drug combination (FDC) of pantoprazole (PPI) and itopride (prokinetic) in 50 patients with ≥3 month history of GERD and overlapping dyspepsia refractory to pantoprazole. Efficacy was assessed as reduction in GERD symptom assessment scale (GSAS) distress score for 15 symptoms from baseline to week 6. Adverse events (AEs) were monitored up to week 6.ResultsAlthough heartburn was the most common symptom at week 6 (26.8%), its frequency significantly decreased from baseline (84.0%; P <0.01). A similar trend was observed for other symptoms: pressure/discomfort inside chest (19.5%), belching (14.6%), regurgitation (12.2%), bloating (9.8%), flatulence (9.8%), early satiety (7.3%), acidic/sour taste in mouth (7.3%), nausea (7.3%), frequent gurgling in stomach/belly (4.9%), and pressure/lump in throat (2.4%). Mean distress scores of all symptoms markedly decreased at week 6. Three AEs (n = 2) of moderate intensity were reported.ConclusionThe FDC of pantoprazole and itopride showed favorable efficacy and safety in patients with GERD and overlapping dyspepsia refractory to pantoprazole monotherapy. Nevertheless, further studies are warranted.

01 Jan 2024·Gastroenterology Review

The efficacy and safety of itopride as an add-on therapy to a proton pump inhibitor in the treatment of gastroesophageal reflux disease

Article

Author: Wasko-Czopnik, Dorota ; Wiatrak, Benita

IntroductionThe primary objective was to demonstrate the efficacy and safety of itopride as an add-on therapy to a proton pump inhibitor (PPI) in the treatment of gastroesophageal reflux disease.AimReflux disease affects the largest percentage of the population worldwide, symptoms overlap with many other conditions which hamper diagnostic and therapy presenting challenges in treating patients and prompting an intensive search for new, more effective therapeutic regimens.Material and methodsA retrospective study was undertaken with 140 enrolled patients with reflux disease, confirmed by 24-hour pH impedance previously treated with PPIs without any significant improvement. Itopride was added to the PPI therapy in a dose of 150 mg/day, after which the severity of reflux disease symptoms was reassessed.ResultsThe greatest improvement after the combined treatment (p < 0.001) was experienced in the context of heartburn, nausea and laryngopharyngeal symptoms. There was also a high percentage of statistically significant (p < 0.01) improvement in burning in the oesophagus and stomach and regarding postprandial fullness, gastric retention and swallowing disorders. No adverse effects were noted.ConclusionsThe presented study clearly demonstrates that in patients ineffectively treated with PPIs, the addition of itopride to the therapy for 8 weeks without changing the PPI dose, significantly improves the efficacy of treatment of reflux disease and thus shortens the need for medication usage and reduces the costs of therapy, potential side effects of PPI, improves the patient's quality of life and decreases the frequency of medical appointments.

100 Deals associated with Itopride Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D02729	Itopride Hydrochloride	A03FA07	DB04924

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Gastrointestinal Diseases	IN	AbbVie AS	20 Jan 2003
Chronic gastritis	JP	Viatris Pharmaceutical GK	30 Jun 1995
Heart Failure	CN	-	-
Hypertension	CN	-	-
Nausea	-	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic gastritis	Phase 3	MY	Abbott Laboratories	28 Feb 2024
Chronic gastritis	Phase 3	AM	Abbott Laboratories	28 Feb 2024
Heartburn	Discovery	US	Forest Laboratories LLC	01 Oct 2006
Intestinal Diseases	Discovery	US	Axcan Pharma (Australia) Pty Ltd.	01 Nov 2005
Nausea	Discovery	US	Forest Laboratories, Inc.	01 Aug 2005
Vomiting	Discovery	US	Forest Laboratories, Inc.	01 Aug 2005
Diabetes Mellitus, Insulin-Dependent, 2	Discovery	AU	Forest Laboratories, Inc.	01 Mar 2005
Gastroparesis	Discovery	AU	Forest Laboratories, Inc.	01 Mar 2005
Abdomen distended	Discovery	CA	Forest Laboratories, Inc.	01 Jul 2004
Dyspepsia	Discovery	DE	Abbott India Ltd.	01 Dec 2000

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW	Not Applicable	-	-	Itopride 50mg	ljjvzbzslj(flqxfhcfcj) = lguqvfmzfr krdmhvlgof (kyxnnmnbnd, 25)	-	01 Oct 2018
				Itopride 100mg	ljjvzbzslj(flqxfhcfcj) = nrenbyuvxp krdmhvlgof (kyxnnmnbnd, 32)
ASCO2005	Not Applicable	Postoperative ileus	-	Itopride hydrochloride 50 mg	(xhjusdobga) = zbsvgyfhbx aiqrxorelu (lmqjcivpzp ) View more	-	01 Jun 2005
				Placebo	(xhjusdobga) = tmejlpdimf aiqrxorelu (lmqjcivpzp ) View more