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Dexamethasone Ear Solution |
Decadron Ear Solution |
Clinical Trial: A Study of Ramosetron Plus DX, Dexamethasone, Compared to Granisetron Plus DX for the Prevention of Vomiting and Nausea.
This study is not yet open for patient recruitment.
Verified by Astellas Pharma US, Inc. January 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Vomiting Nausea | Drug: Ramosetron, granisetron, dexamethasone | Phase III |
MedlinePlus related topics: Nausea and Vomiting
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Ages Eligible for Study: 20 Years - 74 Years, Genders Eligible for Study: Both
Criteria
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 including
- 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 7. Female subject who is pregnant or breastfeeding 8. Subject with life expectancy less than 3 months 9. Subject participated other investigational drug trial within 1 month before entering this study
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00272285
Department of Medical & Regulatory Affairs, Astellas Pharma Taiwan, Inc. +886-2-2507-5799
Taiwan
Taipei, 105, Taiwan
Tainan, Taiwan
Study chairs or principal investigators
Tsu-Yi Chao, MD, Principal Investigator, Division of Hematology/Oncology, Tri-Service General Hospital, National Defense Medical Center
More Information
Study ID Numbers: 06003/TnIO01
Last Updated: January 4, 2006
Record first received: January 3, 2006
ClinicalTrials.gov Identifier: NCT00272285
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: January 4, 2006
Record first received: January 3, 2006
ClinicalTrials.gov Identifier: NCT00272285
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2006-01-10
Resources
- Decadron Ear Solution (Drug Digest)
- Dexamethasone Ear Solution (Drug Digest)
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