Symptoms and General Pathology

All Conditions

Nausea

Vomiting

Postoperative Nausea and Vomiting

Signs and Symptoms, Digestive

Postoperative Complications

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Fosaprepitant

Aprepitant

Cisplatin

Dexamethasone acetate

Ramosetron

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Neurokinin-1 Receptor Antagonists

Substance P

Neurokinin A

Neurotransmitter Agents

Serotonin

Day 1:

Aprepitant 125 mg PO, 1 hour before chemotherapy Ramosetron 0.6 mg IV, 30 min before chemotherapy Dexamethasone 12 mg PO, 30 min before chemotherapy

Day 2 - 3:

Aprepitant 80 mg PO. in the morning Dexamethasone 8 mg PO. in the morning

Day 4 Dexamethasone 8 mg PO. in the morning

Ramosetron, Aprepitant, Dexamethasone

Hyo Jung Kim, M.D.

Cisplatin is one of the most emetogenic drugs used in clinical practice and it could result in poor compliance with chemotherapy. The 5-HT3 receptor antagonists prevent vomiting in acute phase emesis after chemotherapy in 73 - 92% of cisplatin-treated patients when coadministered with steroids, but they appear to lack efficacy in the delayed phase emesis. Ramosetron, a new 5-HT3 receptor antagonists, has been shown to have equivalent efficacy and tolerability and a longer duration of effect than granisetron in preventing acute vomiting in patients undergoing cisplatin-containing chemotherapy. Acute phase emesis was prevented in 84.8% of patients receiving ramosetron plus dexamethasone, but the CR rate of total phase emesis was less than 60%.

Aprepitant is a selective, high-affinity NK1 receptor antagonist. Adding aprepitant to 5-HT3 receptor antagonists and steroid improve CR rate of not only chemotherapy induced acute emesis and but also delayed emesis by 11-14 and 20 percentage points, respectively.

But until now, there was no information that which 5-HT3 receptor antagonists is the best partner for aprepitant. Therefore, we initiated a prospective, open-label, phase II study to assess the efficacy and tolerability of a combination of ramosetron, aprepitant and dexamethasone (RAD) in the prevention of cisplatin based CINV in chemotherapy-naïve patients with solid cancer

Cisplatin is one of the most emetogenic drugs used in clinical practice and it could result in poor compliance with chemotherapy. The 5-HT3 receptor antagonists prevent vomiting in acute phase emesis after chemotherapy in 73 - 92% of cisplatin-treated patients when coadministered with steroids, but they appear to lack efficacy in the delayed phase emesis. Ramosetron, a new 5-HT3 receptor antagonists, has been shown to have equivalent efficacy and tolerability and a longer duration of effect than granisetron in preventing acute vomiting in patients undergoing cisplatin-containing chemotherapy. Acute phase emesis was prevented in 84.8% of patients receiving ramosetron plus dexamethasone, but the CR rate of total phase emesis was less than 60%.

Ramosetron, Aprepitant and Dexamethasone (RAD) in Solid Cancer

A Phase II Study to Evaluate the Efficacy and Tolerability of Ramosetron, Aprepitant and Dexamethasone (RAD) in Preventing Cisplatin-induced Nausea and Vomiting in Chemotherapy-naïve Patients With Solid Cancer

Merck Sharp & Dohme LLC

Hallym University Medical Center

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.

In contrast, patients in the control group are given the same volume of normal saline after induction and given a 0.3 mg of ramosetron after measurement of QTc interval.

Normal saline

Intraperitoneal insufflation of carbon dioxide may affect the sympathetic activity that leads to changes in ventricular re-polarization. This in turn can result in changes of heart rate-corrected QT (QTc) interval. Ramosetron is a 5-hydroxytryptamine three receptor antagonist and widely used anti-emetics. However, QTc interval prolongation has been observed in a number of patients after administration of 5-HT3 receptor antagonists. The aim of this study is to evaluate the effects of ramosetron on QTc interval and possible cardiovascular adverse effects during robot-assisted laparoscopic prostatectomy with steep Trendelenburg position.

Intraperitoneal insufflation of carbon dioxide may affect the sympathetic activity that leads to changes in ventricular re-polarization. This in turn can result in changes of heart rate-corrected QT (QTc) interval. Ramosetron is a 5-hydroxytryptamine three receptor antagonist and widely used anti-emetics. However, QTc interval prolongation has been observed in a number of patients after administration of 5-HT3 receptor antagonists. The aim of this study is to evaluate the effects of ramosetron on QTc interval and possible cardiovascular adverse effects during robot-assisted laparoscopic prostatectomy with steep Trendelenburg position. Fifty-six patients, aged more than 19 years, undergoing robot-assisted laparoscopic prostatectomy will be divided into ramosetron group (n=28) and control group (n=28). Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction. In contrast, patients in the control group are given the same volume of normal saline after induction and given a 0.3 mg of ramosetron after measurement of QTc interval. The primary endpoint is the difference in maximal change of QTc interval between groups.

Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction. In contrast, patients in the control group are given the same volume of normal saline after induction and given a 0.3 mg of ramosetron after measurement of QTc interval.

Participants, care provider and investigator are blinded to group assignment.

Effect of Ramosetron on Heart Rate-corrected QT Interval During Robot-assisted Laparoscopic Prostatectomy With Steep Trendelenburg Position

Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.

Yonsei University

Emetics

Anti-Infective Agents

Palonosetron

BB 1101

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Serotonin 5-HT3 Receptor Antagonists

1. Ramosetron 0.3mg IV day1
2. Aprepitant 125mg PO qd day1, 80mg po qd day 2, 3
3. Dexamethasone 12mg IV or PO qd day1, 8mg PO day 2, 3, 4

1. Palonosetron 0.25mg IV day1
2. Aprepitant 125mg PO qd day1, 80mg po qd day 2, 3
3. Dexamethasone 12mg IV or PO qd day1, 8mg PO day 2, 3, 4

ramosetron 0.3 mg IV D1 aprepitant 125 mg PO D1, 80 mg PO D2, 80 mg PO D3 dexamethasone 12 mg PO D1, 8 mg PO D2-4

ramosetron, aprepitant, dexamethasone

palonosetron 0.25 mg IV D1 aprepitant 125 mg PO D1, 80 mg PO D2, 80 mg PO D3 dexamethasone 12 mg PO D1, 8 mg PO D2-4

palonosetron, aprepitant, dexamethasone

Jin-Hyoung Kang, Ph.D

Jung Hye Kwon, PhD

The purpose of this study is to compare the anti-emetic effect of ramosetron plus aprepitant and dexamethasone with palonosetron plus aprepitant and dexamethasone in patients receiving highly emetogenic chemotherapy.

Currently, palonosetron is the clinically preferred antiemetic for Chemotherapy-induced nausea and vomiting (CINV).However the best 5-hydroxytryptamine 3 receptor (5-HT3R) antagonists for use in a triple drug combination for high emetogenic chemotherapy(HEC) has not yet been determined in randomized trials. Previous anti-emetic guidelines stated that the anti-emetic activities of 5-HT3R antagonists were similar at equivalent doses. Based on the meta-analysis of various 5-HT3R antagonists in double regimens, the NCCN guideline has suggested palonosetron as a preferred 5-HT3R antagonist in the triple antiemetic drug combination. But in Asia, RAD is one of the most popular treatments for HEC-treated cancer patients. However, the lack of clinical studies has precluded the recommendation of RAD as a standard regimen for HEC-induced CINV. In two previous studies conducted in Korea, RAD regimen showed significant efficacy for prevention of CINV which is comparable to the efficacy reported from the studies evaluating with PAD regimen. If the efficacy of RAD regimen is evidently proven by this kind of randomized multicenter-trial, RAD regimen can be more recommended as a standard regimen for HEC-induced CINV.

Ramosetron, Aprepitant, and Dexamethasone Versus Palonosetron, Aprepitant, and Dexamethasone

Comparison of Ramosetron, Aprepitant, and Dexamethasone (RAD) With Palonosetron, Aprepitant, and Dexamethasone (PAD) for Prevention of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy

The Catholic University of Korea

Astellas Pharma Korea, Inc.

Kangdong Sacred Heart Hospital

Associate Professor

Dermatologic Agents

Analgesics

Central Nervous System Depressants

Ondansetron

Morphine

ramosetron

ondansetron

The purpose of this study is:

1. To compare prophylactic effect of ondansetron versus ramosetron on radiotherapy induced nausea and vomiting in the treatment of gastrointestinal cancer.
2. To verify an improvement of 20% in complete response rate in term of radiotherapy induced nausea and vomiting (from 60% with ondansetron to 80% with ramosetron).

Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

Phase III Prospective Randomized Trial Comparing Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting in the Treatment of Gastrointestinal Cancer

Seoul National University Hospital

Eui Kyu Chie/Assistant Clinical Professor

Skin and Connective Tissue Diseases

Breast Neoplasms

receive ramosetron i.v. 0.3mg at the end of surgery without additional ramosetron

receive ramosetron i.v. 0.3mg at the end of surgery with two additional doses of ramosetron at 12- and 24- hour postoperative time points

receive ramosetron i.v. 0.3mg at the end of surgery followed ramosetron 0.6 mg mix with the patient-controlled analgesia (PCA) regimen

we injected two additional remosetron doses in different way in experimental groups. In group B, patients received additional ramosetron at 12 hour interval, in group M, patients received additional ramosetron in mixed with the patient controlled analgesia regimen.

Ramosetron Hydrochloride

The purpose of this study was to evaluate the effectiveness of additional ramosetron injection for controlling late postoperative nausea and vomiting (PONV) after breast surgery in high risk PONV patients. The investigators compared PONV amomng 3 groups- group C: no additional ramosteron, group B: two additional ramosteron doses at 12 hour interval, group M: two additional ramosetron doses mix to the intraveonus patient controlled analgesia.

The investigators included high risk patients of PONV with a score of 3 or more as measured by the Apfel's score and over 18 years old who receive breast surgery and intravenous patient controlled analgesia. All patients was received ramosetron 0.3 mg at the end of surgery. The patients were evaluated for number of PONV (nausea, vomiting, retching) at 1, 6, 24, and 48 hours postoperatively. Nausea was defined as an unpleasant feeling of vomiting. Retching was defined as an excessive contraction or a regular movement. of the respiratory muscles where no gastric contents were excreted, and vomiting was defined as the excretion of gastric contents. PONV were further detailed quantified using the RINVR score (Rhodes Index of Nausea, Vomiting, and Retching) which enabled the patients' objective and subjective symptoms to be evaluated as a simple and reliable methods.

Intravenous injection of ondansetron 4 mg was administered as a rescue antiemetic. The patients were evaluated 2 hours after ondansetron administration. If the symptom persisted, use of second rescue antiemetics dexamethasone 5 mg.

Ramosetron on Late PONV (Postoperative Nausea and Vomiting)

The Effect of Additional Administration of Ramosetron on Late PONV (Postoperative Nausea and Vomiting) in Patients Undergoing Breast Surgery

further detaied quantified in PONV experience, total score: 32, none:0, mild: 1-8 point, moderate: 9-16 point, great: 17-24 point, severe: 25-32 point

Pusan National University Hospital

Associate professor

Blood and Lymph Conditions

Hematologic Neoplasms

Hematologic Diseases

Bo-Kyung Kim, RN

Ki-Seong Eom, MD

Jong-Wook Lee, MD

1. The purpose of this study is to determine the efficacy of ramosetron for the prevention of emesis and the control of nausea and vomiting despite of the prophylactic antiemetic treatment during hematopoietic stem cell transplantation
2. The study hypothesis is that ramosetron is effective for the prevention of emesis and control of emesis and/or vomiting that develop after the prophylactic antiemetic therapy in the setting of hematopoietic stem cell transplantation

Efficacy Study of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation

Prospective, Single-arm Phase 2 Trial to Evaluate Efficacy and Safety of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation for Hematologic Malignancies

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Leiomyoma

Myofibroma

Adenomyosis

Myoma

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

San-Hui Lee, M.D.

To compare postoperative nausea and vomiting (PONV) and perioperative outcomes of gynecologic patients undergoing laparoscopic surgery after scheduled administration of intravenous Ramosetron during hospital stays.

* Randomized controlled arm : Placebo versus Ramosetron injection
* Administration schedule : immediate postoperative status, 12 hrs after surgery, 36hrs after surgery

Surgical outcomes including operative time, blood loss, Hb change, postoperative pain, nausea/vomiting scale, times of rescue therapy, and complications

Long Term Prevention of Nausea and Vomiting in Gynecologic Laparoscopy

A Randomized Prospective Study of Scheduled Intravenous Ramosetron for the Prevention of Nausea and Vomiting in Hospitalized Patients After Gynecologic Laparoscopy

National Health Insurance Service Ilsan Hospital

Clinical assistant professor

ramosetron 0.3 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4

ondansetron 16 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4

Hyo Jung Kim, M.D. Ph.D.

Jinjoo Hong, R.N.

Hyo Jung Kim, M.D., Ph.D.

Sangwon Shin, M.D.

The purpose of this study is to assess the efficacy and safety of Ramosetron, Aprepitant and Dexamethasone therapy versus Ondansetron, Aprepitant and Dexamethasone therapy for preventing of nausea and vomiting in highly emetogenic chemotherapy (ROAD study):

Prospective multicenter, randomized, single blinded, phase III study.

To assess the efficacy and safety of Ramosetron, Aprepitant and Dexamethasone therapy versus Ondansetron, Aprepitant and Dexamethasone therapy for preventing of nausea and vomiting in highly emetogenic chemotherapy (ROAD study):

Ramosetron, Aprepitant and Dexamethasone Versus Ondansetron, Aprepitant and Dexamethasone

To Assess the Efficacy and Safety of Ramosetron, Aprepitant and Dexamethasone Therapy vs Ondansetron, Aprepitant and Dexamethasone Therapy for Preventing of Nausea and Vomiting in Highly Emetogenic Chemotherapy (ROAD Study)

CR means no vomiting \& no rescue medication

Delayed phase means 'from day 2 to day 5' after onset of chemotherapty whole study period means 'from day 1 to day 5' after onset of chemotherapty (acute phase + delayed phase).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ramosetron, Aprepitant and Dexamethasone (RAD) in Solid Cancer	NCT01046461	Solid Tumour Postoperative N...	Ramosetron, Apr...	18 Years - 75 Years	Hallym University Medical Center
Effect of Ramosetron on Heart Rate-corrected QT Interval During Robot-assisted Laparoscopic Prostatectomy With Steep Trendelenburg Position	NCT03232125	Prostate Cancer	Ramosetron Normal saline	20 Years - 80 Years	Yonsei University
Ramosetron, Aprepitant, and Dexamethasone Versus Palonosetron, Aprepitant, and Dexamethasone	NCT02532634	Cancer Tumors	ramosetron, apr... palonosetron, a...	19 Years -	Kangdong Sacred Heart Hospital
Effect of Ramosetron on Heart Rate-corrected QT Interval During Robot-assisted Laparoscopic Prostatectomy With Steep Trendelenburg Position	NCT03232125	Prostate Cancer	Ramosetron Normal saline	20 Years - 80 Years	Yonsei University
Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting	NCT00971399	Radiotherapy In...	ramosetron ondansetron	20 Years -	Seoul National University Hospital
Ramosetron on Late PONV (Postoperative Nausea and Vomiting)	NCT05326360	Postoperative N... Breast Cancer F...	Ramosetron Hydr...	18 Years -	Pusan National University Hospital
Efficacy Study of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation	NCT01788605	Hematologic Mal...	ramosetron	18 Years -	The Catholic University of Korea
Long Term Prevention of Nausea and Vomiting in Gynecologic Laparoscopy	NCT02011659	Uterine Myoma, ...	Ramosetron	18 Years - 70 Years	National Health Insurance Service Ilsan Hospital
Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting	NCT00971399	Radiotherapy In...	ramosetron ondansetron	20 Years -	Seoul National University Hospital
Ramosetron, Aprepitant and Dexamethasone Versus Ondansetron, Aprepitant and Dexamethasone	NCT01536691	Cancer Malignancy	ramosetron ondansetron	20 Years -	Hallym University Medical Center

Spots Global Cancer Trial Database for ramosetron

Every month we try and update this database with for ramosetron cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ramosetron

Every month we try and update this database with for ramosetron cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ramosetron cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.