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Sponsored by: |
Ono Pharma |
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Information provided by: | Ono Pharma |
ClinicalTrials.gov Identifier: | NCT00212602 |
The purpose of this study is to examine the efficacy and safety of ONO-7436 for the prevention of cancer chemotherapy-induced nausea and vomiting in patients with malignant tumor
Condition | Intervention | Phase |
---|---|---|
Malignant Tumor |
Drug: ONO-7436 |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | ONO-7436 Phase II Study - A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of ONO-7436 for the Prevention of Cancer Chemotherapy-Induced Nausea and Vomiting in Japan |
Estimated Enrollment: | 420 |
Study Start Date: | August 2005 |
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Hokkaido Region Facility | |
Hokkaido, Japan | |
Kanto Region Facility | |
Kanto, Japan | |
Hokuriku Region Facility | |
Hokuriku, Japan | |
Chubu Region Facility | |
Chubu, Japan | |
Tohoku Region Facility | |
Tohoku, Japan | |
Chugoku Region Facility | |
Chugoku, Japan | |
Shikoku Region Facility | |
Shikoku, Japan | |
Kyushu Region Facility | |
Kyushu, Japan | |
Kinki Region Facility | |
Kinki, Japan |
Study Director: | Project Leader, Development Planning | Ono Pharma |
Study ID Numbers: | ONO-7436-01 |
Study First Received: | September 13, 2005 |
Last Updated: | September 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00212602 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
ONO-7436, Aprepitant, Vomiting, Nausea |
Vomiting Nausea Aprepitant |
Neoplasms Autonomic Agents Therapeutic Uses Physiological Effects of Drugs Gastrointestinal Agents |
Antiemetics Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |