Delving into the Latest Updates on Ramosetron Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Ramosctron Hydrochloride, Ramosetron, Ramosetron Hydrocchloride

+ [12]

Target

5-HT3 receptor

Mechanism

5-HT3 receptor antagonists(Serotonin 3 (5-HT3) receptor antagonists)

Therapeutic Areas

Digestive System DisordersOther DiseasesNeoplasms

Active Indication

Irritable Bowel SyndromeNauseaVomiting+ [1]

Inactive Indication

Chemotherapy-induced nausea and vomitingIrritable bowel syndrome with diarrhea

Originator Organization

Astellas Pharma, Inc.

Active Organization

Zhejiang Academy of Medical SciencesHangzhou Paqisi Pharmaceutical Technology Co., Ltd.

LTL Pharma Co., Ltd.

+ [2]

Inactive Organization

Astellas Pharma Europe Ltd.Astellas Pharma Korea, Inc.

Drug Highest PhaseApproved

First Approval Date

JP (10 Jul 1996),

Irritable Bowel SyndromeNauseaVomiting

Regulation-

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Structure/Sequence

Molecular FormulaC17H18ClN3O

InChIKeyXIXYTCLDXQRHJO-RFVHGSKJSA-N

CAS Registry132907-72-3

View All Structures (2)

This clinical trial aims to assess the effectiveness of Ramosetron compared to Psyllium, a gold standard therapy, in patients with fecal incontinence. The primary questions it seeks to answer are:
Does Ramosetron improve the symptoms of fecal incontinence?
Is Ramosetron superior to Psyllium in terms of symptom improvement and its impact on quality of life?
Participants will be randomly assigned to one of two groups, either taking Ramosetron or Psyllium for one month. They will be asked to complete a questionnaire. Researchers will then compare the Fecal Incontinence Severity Index between the Ramosetron and Psyllium groups to determine whether Ramosetron provides superior symptom relief compared to Psyllium.

Start Date15 Dec 2023

Sponsor / Collaborator

Seoul National University Hospital

NCT05577845

/ RecruitingNot ApplicableIIT

Safety & Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) Versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial

Safety & Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial

Start Date27 Mar 2023

Sponsor / Collaborator

Seoul National University Hospital

100 Clinical Results associated with Ramosetron Hydrochloride

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100 Translational Medicine associated with Ramosetron Hydrochloride

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100 Patents (Medical) associated with Ramosetron Hydrochloride

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376

Literatures (Medical) associated with Ramosetron Hydrochloride

01 Dec 2024·Journal of PeriAnesthesia Nursing

Pharmacological Strategies for Postdischarge Nausea and Vomiting: Evidence-based Review Update

Review

Author: Kane, Terri D ; Tubog, Tito D

PURPOSEEvaluate the effectiveness of various drugs in preventing postdischarge nausea and vomiting (PDNV).DESIGNSystematic review.METHODSA search for evidence was conducted in PubMed, CINAHL, Cochrane Collaboration, and Google Scholar and gray literature. Only randomized controlled trials examining a pharmacological agent to prevent PDNV were included in the study. The quality appraisal of the literature was conducted using the proposed algorithm described in the Johns Hopkins Nursing Evidence-Based Practice Evidence Level and Quality Guide.FINDINGSA total of 8 randomized controlled trials involving 1,441 patients were analyzed. The efficacy of pharmacological agents, including dexamethasone, olanzapine, ondansetron, palonosetron, ramosetron, promethazine, and casopitant in the prevention of PDNV, varied. Additionally, a combination of two or more drugs is a more effective therapy than using a single drug in mitigating PDNV. The review also underscored the individual patient factors that can play a significant role in identifying appropriate prevention and treatment modalities.CONCLUSIONSThere is limited evidence on the efficacy of pharmacological agents in preventing PDNV. The scarcity of large-scale, clinical trials specifically focusing on PDNV restricts the ability to recommend prophylactic drug therapy for reducing its incidence.

01 Oct 2024·Dose-Response

Ramosetron 3.0 μg/mL Combining with Dexamethasone (0.05, 0.1, 0.2 mg/mL) in Infusion Solutions: A Physicochemical Stability Study

Article

Author: Chen, Fuchao ; Fang, Baoxia ; Zhao, Lijun ; Yu, Shirong

Background Dexamethasone in conjunction with type 3 serotonin receptor antagonists are being used to the prevention and treatment of chemotherapy-induced nausea and vomiting and postoperative nausea and vomiting in clinic. The present study aimed to investigates the stability of ramosetron with dexamethasone in infusions, with the goal of enhancing the safety and clinical applicability of their combined use. Methods Ramosetron hydrochloride (3.0 μg/mL) combining with dexamethasone (0.05, 0.1, 0.2 mg/mL) were prepared with 0.9% sodium chloride injection and then packaged in polyolefin bags or glass bottles. The stability were investigated kept in the dark at refrigeration for 14 days and at room temperature for 48 h. Results The concentration of both drugs maintained at least 97% in the various solutions for both storage conditions with light protection. In the light exposure conditions, as the extension of storage time, the concentration of both drugs had declined. All antiemetic mixture solutions remained clear and no changes in color, turbidity, precipitation, and the pH remained stable. The insoluble particles were in line with Chinese Pharmacopoeia. Conclusion Our findings suggest that combinations of ramosetron hydrochloride with dexamethasone sodium phosphate in 0.9% sodium chloride injection remain stable for 14 days at 4°C and 48 h at 25°C when protected from light.

01 Sep 2024·Rheumatology

Ramosetron as an add-on therapy for refractory fibromyalgia: a randomized, double-blind, placebo-controlled trial

Article

Author: Lee, Jung-Kil ; Park, Dong-Jin ; Lee, Shin-Seok ; Choi, Sung-Eun ; Jeong, Hyemin ; Kang, Ji-Hyoun

AbstractObjectiveThis study aimed to assess the efficacy and safety of intravenous ramosetron for pain relief in patients with fibromyalgia (FM) unresponsive to conventional treatments.MethodsIn this prospective, double-blind, placebo-controlled trial, 80 FM patients were randomly allocated to receive either placebo (n = 40) or ramosetron (n = 40) at a dosage of 0.3 mg/day intravenously for five consecutive days. The primary outcome was the reduction in pain intensity at the end of the treatment period, evaluated using a visual analogue scale (VAS). Secondary outcome measures included the FM Impact Questionnaire, Beck Depression Inventory (BDI), Multi-Dimensional Health Assessment Questionnaire (MDHAQ), EQ-5D and State-Trait Anxiety Inventory on days 5 (end of treatment), 7, 10 and 28. Safety was continuously monitored throughout the study.ResultsAt the end of the treatment phase, the ramosetron group demonstrated a significantly greater reduction in VAS pain scores compared with the placebo group (1.18 ± 1.60 vs 0.54 ± 1.59, P < 0.05). Additionally, the ramosetron group exhibited significant improvements in BDI (4.42 ± 5.18 vs 1.33 ± 4.87, P < 0.05) and MDHAQ pain scale (0.37 ± 0.74 vs 0.04 ± 0.52, P < 0.05) scores. However, these improvements in pain VAS and BDI scores were not sustained through day 28. The safety profile of ramosetron was favorable, with gastrointestinal symptoms, particularly constipation, being the most commonly reported adverse events.ConclusionsIntravenous administration of ramosetron provided safe and effective short-term relief of pain intensity in FM patients with inadequate response to standard treatments.

100 Deals associated with Ramosetron Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D02016	Ramosetron Hydrochloride	A04AA	DB09290

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Irritable Bowel Syndrome	JP	Astellas Pharma, Inc.	10 Jul 1996
Nausea	JP	LTL Pharma Co., Ltd.	10 Jul 1996
Nausea	JP	Astellas Pharma, Inc.	10 Jul 1996
Vomiting	JP	LTL Pharma Co., Ltd.	10 Jul 1996
Vomiting	JP	Astellas Pharma, Inc.	10 Jul 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Irritable bowel syndrome with diarrhea	Phase 1	JP	Astellas Pharma, Inc.	01 Sep 2012
Neoplasms	Phase 1	KR	Astellas Pharma Korea, Inc.	01 Jun 2011
Chemotherapy-induced nausea and vomiting	Phase 1	TW	Astellas Pharma, Inc.	01 Jan 2006
Nausea	Phase 1	TW	Astellas Pharma, Inc.	01 Jan 2006
Vomiting	Phase 1	TW	Astellas Pharma, Inc.	01 Jan 2006

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


KCT0005441 (Pubmed \| Curr Pharm Des)	Not Applicable	Cough \| Anesthesia	-	Ramosetron 0.3 mg	lvavfefaqb(beiqqvctoa) = cxdmumzgpz jfrgkhueba (imqplcecql ) View more	-	12 Apr 2022
				Normal saline	lvavfefaqb(beiqqvctoa) = ejzdyieqcu jfrgkhueba (imqplcecql ) View more
NCT02869984 (Pubmed \| Br J Surg)	Early Phase 1	Rectal Cancer	100	Ramosetron	dvlujhrlau(wkssfzriha) = lltczteziz dbenauhhdw (llbcbwjofh )	Positive	13 May 2021
				ramosetron (Conservative treatment)	dvlujhrlau(wkssfzriha) = hidknozuau dbenauhhdw (llbcbwjofh )
NCT02011659 (Pubmed)	Phase 3	Postoperative Nausea and Vomiting	-	Ramosetron	qlxafcoaok(brysotbban) = hsofyufjmy wheqeuzszi (onpgluvnhu )	-	01 Sep 2019
				Placebo	qlxafcoaok(brysotbban) = qurxzrebad wheqeuzszi (onpgluvnhu )
NCT01274000 (Pubmed \| Neurogastroenterol Motil)	Phase 2	Irritable bowel syndrome with diarrhea	409	2.5 μg of ramosetron	uttpzdnhxu(roalstnfgv) = xwhbiwytvw kbzzlefpjo (bkqbrdzedf )	-	01 Jun 2017
NCT02617121 (Pubmed \| BMC Anesthesiol)	Not Applicable	Postoperative Nausea and Vomiting	-	Gabapentin	(mbhjvfoxib) = vfuwdaxudx trhxegejgs (amudwyqrkb )	-	19 May 2017
				Ramosetron	(mbhjvfoxib) = jyzwtpzyvv trhxegejgs (amudwyqrkb )
NCT00918411 (Pubmed \| Biopsychosoc Med)	Phase 4	Irritable bowel syndrome with diarrhea	98	Ramosetron 5 μg	croqxyebxy(ksuzssqqai) = jnxvfzjfra fpgbquresd (rwmyooosfa ) View more	-	01 Jan 2017
				Placebo	croqxyebxy(ksuzssqqai) = gtmufkqmvd fpgbquresd (rwmyooosfa ) View more
NCT01736423 (Pubmed \| J Gastroenterol) Manual	Phase 3	Irritable bowel syndrome with diarrhea	123	ramosetron	(qxjgnehfig) = 19.7 % in 2.5 μg and 10.5 % in 5 μg dqzotqzmnm (wmsudusatn ) View more	Positive	01 Sep 2016
				Ramosetron 5 μg
NCT02139241 (Pubmed)	Not Applicable	-	114	Ramosetron	fzjushxhzd(gydtfhrump): P-Value = 0.040; P-Value = 0.021	-	03 Aug 2016
				Placebo
KCT0000688 (Pubmed \| BMC Anesthesiol)	Not Applicable	Postoperative Nausea and Vomiting	-	Placebo	(rrvxgqvcil) = jeolgupksc dgqnhlemud (wzmmffbrcb )	-	22 Jul 2016
				Ondansetron	(rrvxgqvcil) = cjdqmnnkqr dgqnhlemud (wzmmffbrcb )
NCT01870895 (Pubmed \| J Laparoendosc Adv Surg Tech A \| Gastroenterology) Manual	Phase 3	Diarrhea \| Irritable Bowel Syndrome	576	Ramosetron	whctwirkoc(ordspffmwm) = dowgtuewpn kgudptjbto (xkqxkfmnzb, 44.8 - 56.6) View more	Positive	01 Feb 2016
				Placebo	whctwirkoc(ordspffmwm) = ncwklgfqau kgudptjbto (xkqxkfmnzb, 26.7 - 37.8) View more