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

/ Active, not 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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426

Literatures (Medical) associated with Itopride Hydrochloride

02 Jan 2025·Expert Opinion On Drug Safety

Risk of drug-induced delirium in older patients- a pharmacovigilance study of FDA adverse event reporting system database

Article

Author: Li, Jiayu ; Zhou, Ying ; Jia, Boying ; Zhou, Shuang ; Wan, Liyan ; Cui, Yimin

BACKGROUND:

Drug-induced delirium is known risk factors associated with increased morbidity and mortality in older patients. The objective was to evaluate the risk of drug-related delirium in older patients based on the FDA Adverse Event Reporting System (FAERS).

RESEARCH DESIGN AND METHODS:

Delirium reports in older patients (age ≥65) extracted from the FAERS database using Open Vigil 2.1. The reported odds ratio and the proportional reported ratio were calculated to detect the adverse reaction signal of delirium. Combined with published evidence, suspected drugs were categorized as known, possible, or new potential delirium-risk-increasing drugs.

RESULTS:

Of the 130,885 reports (including 28,850 delirium events and 1,857 drugs) analyzed for this study, 314 positive signal drugs were detected. Positive signal drugs are mainly concentrated on the drug of nervous system, cardiovascular system , alimentary tract and metabolism and anti-infectives for systemic use. Of the positive signal drugs, 26.11% (82/314) were known delirium-risk increasing drugs, 44.90% (141/314) were possible and 28.98% (91/314) were new potential.

CONCLUSION:

Drug-induced delirium risk is prevalent in older patients, according to the FAERS. The risk level of drug-induced delirium should be taken into account to optimize drug therapy in clinical practice.

01 Jan 2025·Therapeutic Advances in Gastroenterology

Itopride in functional dyspepsia: open-label, 1-year treatment follow-up of two multicenter, randomized, double-blind, placebo-controlled trials

Article

Author: Tack, Jan ; Broeders, Bert ; Talley, Nicholas J.

Background::

Functional dyspepsia (FD) is common but few efficacious therapies exist. Itopride, a prokinetic, acts via dopamine D2 receptor antagonism and acetylcholinesterase inhibition, and is now approved in Japan, Mexico, and Europe for FD. However, long-term efficacy and safety data have not been published.

Objective::

To evaluate the long-term safety and potential effectiveness of itopride.

Design::

A long-term open-label drug effectiveness study.

Methods::

Males and females, 18–65 years, with FD (Rome II) and the absence (by upper endoscopy) of any relevant structural disease were recruited. After the double-blind treatment phase, patients were treated in an open-label extension phase.

Results::

A total of 798 patients were included in these two open-label trials and received at least one dose of study medication; 551 patients (69.0%) completed 6 months of treatment, and 294 patients (36.8%) completed a 12-month period. Response rates based on the global physician assessment were 61.7%, 64.8%, 69.0 %, 69.1%, 70.1%, 73.1%, and 77.9% at weeks 8, 16, 24, 32, 40, 48, and 52, respectively. Compliance was above 95%. The safety and tolerability profiles were as expected, with the majority of adverse events being gastrointestinal. Prolactin elevations occurred in 3% of the cases but were not clinically significant. No ECG changes were identified.

Conclusion::

In this population, itopride, given for up to 12 months, was safe, and up to two-thirds appeared to maintain symptom benefit.

Trial registration::

NCT00110968 and NCT00112203.

01 Jan 2025·ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Clinical Trial: Treatment of Functional Dyspepsia According to Subtype Compared With Empirical Proton Pump Inhibitor

Article

Author: Hian, Wen Xuan ; Mahadeva, Sanjiv ; Khoo, Stanley ; Chuah, Kee Huat ; Natarajan, Vicraman ; Khoo, Xin Hui ; Jubri, Nurhidayah Binti Mohammad ; Loo, Qing Yuan ; Panirsheeluam, Sarala

ABSTRACT:

Background:

International guidelines recommend contrasting initial treatment strategies for functional dyspepsia (FD).

Aims:

To evaluate the efficacy and safety of treatment according to subtypes, compared with empirical proton pump inhibitor (PPI), in the initial treatment of FD.

Methods:

We performed a single‐blinded, randomised controlled trial of adults with FD. In the intervention group (treatment according to subtype), patients were categorised into epigastric pain syndrome (treatment esomeprazole); postprandial distress syndrome (PDS; treatment itopride) and overlap (treatment itopride, maintain, add/or switch to esomeprazole at week 4). The control group received esomeprazole only. The primary efficacy outcome was the assessment of global symptom improvement (primary end point: best two points from the 7‐point Likert scale) over 8 weeks. Secondary outcomes included assessment of the change in nine individual upper gastrointestinal symptoms, quality of life (Short‐Form Nepean Dyspepsia Index) and adverse events.

Results:

We randomised 180 patients (median age: 50; 68.7% female 56.7% PDS) 1:1 into intervention and control arms. The percentage of patients achieving the primary efficacy outcome were 74.4% and 72.2%, respectively (p = 0.74). The improvement of individual symptoms in both groups were similar. The SF‐NDI improved after treatment in both groups (p < 0.001) but there was no significant difference in the degree of change between groups. Rates of adverse events between groups were similar at week 8.

Conclusion:

Initial treatment of FD according to subtype was not more effective than empirical PPI alone for up to 8 weeks. Further multicentre studies, with a larger sample size, are recommended to validate these findings.Trial Registration: ClinicalTrials.gov identifier: NCT04918017

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	India	AbbVie AS	20 Jan 2003
Chronic gastritis	Japan	Viatris Pharmaceutical GK	30 Jun 1995
Heart Failure	China	-	-
Hypertension	China	-	-
Nausea	-	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Postprandial distress syndrome	Phase 3	Armenia	Abbott Laboratories	28 Feb 2024
Postprandial distress syndrome	Phase 3	Malaysia	Abbott Laboratories	28 Feb 2024
Postprandial distress syndrome	Phase 3	Philippines	Abbott Laboratories	28 Feb 2024
Postprandial distress syndrome	Phase 3	Thailand	Abbott Laboratories	28 Feb 2024
Postprandial distress syndrome	Phase 3	Vietnam	Abbott Laboratories	28 Feb 2024
Heartburn	Phase 3	United States	Forest Laboratories LLC	01 Oct 2006
Intestinal Diseases	Phase 3	United States	Axcan Pharma (Australia) Pty Ltd.	01 Nov 2005
Abdomen distended	Phase 3	Canada	Forest Laboratories, Inc.	01 Jul 2004
Dyspepsia	Phase 3	Germany	Abbott India Ltd.	01 Dec 2000
Irritable bowel syndrome with constipation	Phase 2	Pakistan	Abbott Laboratories	01 Jun 2008

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW2018	Not Applicable	-	-	Itopride 50mg	qoxnedoyyv(jtsxxxkvzs) = albrjssikb oypuvzdnih (giowvmwnbs, 25)	-	01 Oct 2018
				Itopride 100mg	qoxnedoyyv(jtsxxxkvzs) = fxxchshdmf oypuvzdnih (giowvmwnbs, 32)
ASCO2005	Not Applicable	Postoperative ileus	-	Itopride hydrochloride 50 mg	fzmcvgwfni(ohjcfcjbek) = mnpnjfylav ysachmqivn (zmllkupntd ) View more	-	01 Jun 2005
				Placebo	fzmcvgwfni(ohjcfcjbek) = xrnnkpvdub ysachmqivn (zmllkupntd ) View more