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Sponsors and Collaborators: |
Hangzhou Jiuyuan Gene Engineering Co. Ltd., Sun Yat-sen University Hangzhou Tigermed Consulting Co., Ltd. |
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Information provided by: | Hangzhou Jiuyuan Gene Engineering Co. Ltd., |
ClinicalTrials.gov Identifier: | NCT00503386 |
The purpose of this study is to determine whether palonosetron is tolerate and effective in preventing chemotherapy-induced nausea and vomiting in oriental population. The study is comparing the safety and efficacy of palonosetron with granisetron, a frequently used antiemetic in China.
Condition | Intervention | Phase |
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Nausea Vomiting Chemotherapy |
Drug: Palonosetron Drug: Granisetron |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Phase II,Multicenter,Randomized,Double-Blind,Cross-Over Study of Palonosetron Compared With Granisetron in Prevention of Chemotherapy-Induced Nausea and Vomiting in Asian Population |
Enrollment: | 144 |
Study Start Date: | April 2006 |
Study Completion Date: | October 2006 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China | |
Beijing Institute on Thoracic Cancer and Tuberculosis | |
Beijing, China, 101149 | |
China, Fujian | |
Fujian Provincial Tumor Hospital | |
Fuzhou, Fujian, China, 350014 | |
China, Guangdong | |
Sun Yat-sen University Cancer Center | |
Guangzhou, Guangdong, China, 510060 | |
China, Hunan | |
Hunan Provincial Tumor Hospital | |
Changsha, Hunan, China, 410006 | |
China, Jiangsu | |
Jiangsu Provincial Tumor Hospital | |
Nanjing, Jiangsu, China, 210009 | |
China, Zhejiang | |
The Second Hospital Affiliated to Zhejiang University | |
Hangzhou, Zhejiang, China, 310009 |
Principal Investigator: | Tongyu Lin, M.D. | Sun Yat-sen University |
Study ID Numbers: | HJGene_SYat-sen_06_01 |
Study First Received: | July 16, 2007 |
Last Updated: | January 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00503386 History of Changes |
Health Authority: | China: State Food and Drug Administration |
chemotherapy-induced nausea and vomiting acute delayed emesis |
antiemetics 5-HT3 receptor antagonist granisetron palonosetron |
Signs and Symptoms Neurotransmitter Agents Palonosetron Vomiting Signs and Symptoms, Digestive |
Antiemetics Nausea Peripheral Nervous System Agents Granisetron Serotonin |
Neurotransmitter Agents Vomiting Molecular Mechanisms of Pharmacological Action Signs and Symptoms, Digestive Physiological Effects of Drugs Gastrointestinal Agents Antiemetics Pharmacologic Actions Signs and Symptoms |
Serotonin Antagonists Palonosetron Serotonin Agents Autonomic Agents Therapeutic Uses Nausea Granisetron Peripheral Nervous System Agents Central Nervous System Agents |