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NCT00272285 Clinical Trial

A Study of Ramosetron Plus DX, Dexamethasone, Compared to Granisetron Plus DX for the Prevention of Vomiting and Nausea

Nausea Clinical Trial

Official title:
A Double-blind, Randomized, Parallel, Comparative Study to Evaluate the Efficacy and Safety of Ramosetron Plus Dexamethasone Injection for the Prevention of Chemotherapy-Induced Vomiting and Nausea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00272285
Other study ID # 06003/TnIO01
Secondary ID
Status Completed
Phase Phase 3
First received January 3, 2006
Last updated March 7, 2017
Start date January 2006
Est. completion date March 2008

Study information
Verified date March 2017
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety of ramosetron plus dexamethasone injection with granisetron plus dexamethasone injection for the prevention of chemotherapy-induced vomiting and nausea.

Recruitment information / eligibility
Status Completed
Enrollment 287
Est. completion date March 2008
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender All
Age group 20 Years to 74 Years
Eligibility Inclusion Criteria:

- Subject with age between 20-74 years old (inclusive) of either sex

- Cancer subject is scheduled to receive the designated chemotherapy programs

- Subject without symptoms of vomiting for at least one week before dosing trial medication

- Subject with ECOG performance status scale no greater than 2

- Subject has signed the written informed consent form

Exclusion Criteria:

- Subject has received radiotherapy to the abdomen or pelvis within 4 weeks before entering this study

- Subject has received the designated chemotherapy programs within 6 months before entering the study

- Subject has known heart failure or myocardial infraction or with laboratory abnormalities at screening

- Subject has known concurrent diseases that may cause vomiting

- Subject has taken medications that could influence the outcome of the study within 3 days before entering the study

- Subject with a history of allergy or intolerance to ramosetron, granisetron or dexamethasone

- Female subject who is pregnant or breastfeeding

- Subject with life expectancy less than 3 months

- Subject participated other investigational drug trial within 1 month before entering this study

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ramosetron
IV, concomitant administration with dexamethasone
• Granisetron
IV, concomitant administration with dexamethasone

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Astellas Pharma Inc Astellas Pharma Taiwan, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients without vomiting after the start of chemotherapy for 24 hours 1 Day
Secondary Response rate of vomiting prevention 1 Day
Secondary The number of vomiting episodes 1 Day
Secondary The nausea degree evaluated by patient's 10-cm visual analogue scale (VAS) 1 Day
See also
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Not yet recruiting NCT06464926 - Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE) N/A
Not yet recruiting NCT06055192 - Prevalence and Burden of Nausea and Vomiting in Pregnant Women in Switzerland: Survey Purity 2022
Recruiting NCT04091789 - Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea Phase 2
Completed NCT02462811 - A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Acute Pain and Opioid-Induced Nausea and Vomiting (OINV) Phase 3
Completed NCT01007500 - Effect of Dexamethasone Combined With Ondansetron on Postoperative Nausea and Vomiting in Patients With Patient-controlled Analgesia After Video-assisted Thoracoscopic Surgery Phase 4
Recruiting NCT00528554 - Laser Acupuncture Against Nausea in Children N/A
Completed NCT00537875 - Evaluation of the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens N/A
Completed NCT00394966 - A Multicenter, Randomized, Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (Study P04351AM2)(COMPLETED) Phase 2
Completed NCT00947128 - To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions Phase 1
Completed NCT00946387 - To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions Phase 1
Recruiting NCT05433636 - Mindful Waiting Room N/A
Not yet recruiting NCT04827108 - Psychometric Properties of the Chinese Version of PeNAT
Not yet recruiting NCT04853303 - VR to Improve CINV, Sleep and Pain Among Children With Cancer in HK N/A
Terminated NCT04247100 - A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders N/A
Recruiting NCT04181346 - Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting Phase 2
Recruiting NCT03679182 - Efficacy and Safety of Olanzapine for the Treatment of Nausea and Vomiting in Palliative Cancer Care Phase 2
Completed NCT02618343 - EMS Use of Isopropyl Alcohol Aromatherapy Versus Ondansetron N/A
Terminated NCT01405924 - Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030) Phase 2

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