Delving into the Latest Updates on Ramosetron Hydrochloride with Synapse

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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365

Literatures (Medical) associated with Ramosetron Hydrochloride

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 ; Choi, Sung-Eun ; Lee, Shin-Seok ; 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.

01 Aug 2024·Clinical Therapeutics

Dosing Strategy of Ramosetron to Prevent Postoperative Nausea and Vomiting and Development of Prediction Models Using Data Obtained From Randomized Controlled Trials: A Comparative Study

Article

Author: Kim, Dong Ho ; Lee, Eun-Kyung ; Noh, Gyu-Jeong ; Kim, Eunha ; Choi, Byung-Moon ; Kim, Kyung Mi ; Bang, Ji-Yeon

PURPOSEThe study aimed to compare the postoperative nausea and vomiting (PONV) preventive effect of repeated administration of ramosetron with the standard treatment group and compare models to predict the incidence of PONV using machine-learning techniques.METHODSA total of 261 patients scheduled for breast surgery were analyzed to evaluate the effectiveness of repeated intravenous administration of ramosetron. All patients were administered 0.3 mg ramosetron just before the end of surgery. For the repeated dose of ramosetron group, an additional dose of 0.3 mg was administered at 4, 22, and 46 hours after the end of the surgery. Postoperative nausea, vomiting, and retching were evaluated using the Rhodes Index of Nausea, Vomiting, and Retching at 6, 24, and 48 hours postoperatively. Previously published randomized controlled data were combined with the data of this study to create a new dataset of 1390 patients, and machine-learning-based PONV prediction models (classification tree, random forest, extreme gradient boosting, and neural network) was constructed and compared with the Apfel model.FINDINGSFifty patients (38.5%) and 60 patients (45.8%) reported nausea, vomiting, or retching 48 hours postoperatively in the standard and repeated-dose groups, respectively (P = 0.317, χ² test). Median sensitivity, specificity, and accuracy of the Apfel model analyzed using the training set were 0.815, 0.344, and 0.495, respectively.IMPLICATIONSThe repeated administration of ramosetron did not reduce the incidence of PONV. The Apfel model had high sensitivity, however, its specificity and accuracy were lower than that in machine-learning-based models.

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	Astellas Pharma, Inc.	10 Jul 1996
Vomiting	JP	LTL Pharma Co., Ltd.	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

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed \| Curr Pharm Des	Not Applicable	Cough \| Anesthesia	-	Ramosetron 0.3 mg	ouiulmeqny(wdhvukcmoi) = bemvccawfp knqwaahxac (gfnmmckkag ) View more	-	12 Apr 2022
				Normal saline	ouiulmeqny(wdhvukcmoi) = kevwjkxcia knqwaahxac (gfnmmckkag ) View more
NCT02869984 (Pubmed \| Br J Surg)	Early Phase 1	Rectal Cancer	100	Ramosetron	pqcpcttori(dzxvkbbpns) = rquuoznkja ntybmhbbto (qekaynjnjf )	Positive	13 May 2021
				ramosetron (Conservative treatment)	pqcpcttori(dzxvkbbpns) = mozmnfbfep ntybmhbbto (qekaynjnjf )
NCT02011659 (Pubmed)	Phase 3	Postoperative Nausea and Vomiting	-	Ramosetron	(socermkrsq) = ikmhmhbyuo szhsoapkbf (ivxdcrkjxl )	-	01 Sep 2019
				Placebo	(socermkrsq) = nlgycpeibw szhsoapkbf (ivxdcrkjxl )
NCT01274000 (Pubmed \| Neurogastroenterol Motil)	Phase 2	Irritable bowel syndrome with diarrhea	409	2.5 μg of ramosetron	zexvmoyrnq(pakrwmfvft) = jfsfdgjktt kbdxzgjqgx (ooaeensbbw )	-	01 Jun 2017
NCT02617121 (Pubmed \| BMC Anesthesiol)	Not Applicable	Postoperative Nausea and Vomiting	-	Gabapentin	(ivwxevshpc) = fwtlhigshh ftniderypv (wfjnpuyhgp )	-	19 May 2017
				Ramosetron	(ivwxevshpc) = jimtwurgkm ftniderypv (wfjnpuyhgp )
NCT00918411 (Pubmed \| Biopsychosoc Med)	Phase 4	Irritable bowel syndrome with diarrhea	98	Ramosetron 5 μg	kohvuasith(dokoucimvi) = rfdlcjqzqm hjwgpukgic (sfexbuesoe ) View more	-	01 Jan 2017
				Placebo	kohvuasith(dokoucimvi) = rbzrbdfkwb hjwgpukgic (sfexbuesoe ) View more
NCT01736423 (Pubmed \| J Gastroenterol) Manual	Phase 3	Irritable bowel syndrome with diarrhea	123	ramosetron	(poypfeshfe) = 19.7 % in 2.5 μg and 10.5 % in 5 μg ymslyfxkhj (oxyertfiyn ) View more	Positive	01 Sep 2016
				Ramosetron 5 μg
NCT02139241 (Pubmed)	Not Applicable	-	114	Ramosetron	thnzxzwkyu(zsokdnegvp): P-Value = 0.040; P-Value = 0.021	-	03 Aug 2016
				Placebo
KCT0000688 (Pubmed \| BMC Anesthesiol)	Not Applicable	Postoperative Nausea and Vomiting	-	Placebo	(rajadbugsr) = erysaswwai pndtbrpimt (rktlrqzjqh )	-	22 Jul 2016
				Ondansetron	(rajadbugsr) = frjsobhwil pndtbrpimt (rktlrqzjqh )
NCT01870895 (Pubmed \| J Laparoendosc Adv Surg Tech A) Manual	Phase 3	Diarrhea \| Irritable Bowel Syndrome	576	Ramosetron	rpjholgkbo(jecjcpxwiy) = cqqayerfoc ajqxnhlprp (isdeppgqlu, 44.8 - 56.6) View more	Positive	01 Feb 2016
				Placebo	rpjholgkbo(jecjcpxwiy) = qqvsyowssz ajqxnhlprp (isdeppgqlu, 26.7 - 37.8) View more