UMIN ID: C000000304
Registered date:11/01/2006
Randomized controlled trial of two intravenous doses of granisetron (1mg vs 3mg) for the prophylaxis of chemotherapy-induced nausea and vomiting in cancer patients
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | breast cancer , ovarian cancer , cervical cancer , endometrial cancer , etc |
Date of first enrollment | 2006/01/01 |
Target sample size | 180 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Granisetron 1mg/body (drip on intravenous,day1) Granisetron 3mg/body (drip on intravenous,day1) |
Outcome(s)
Primary Outcome | Complete Response |
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Secondary Outcome | Complete control |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | (1)patients with known hypersensitivity to 5-HT3 receptor antagonist (2)patients to use the neoplastic agents belong to the acute emetic category intermediate and High risk or to do the radiation therapy between Day2 and 7 (3)serious complications excepting malignancy (e.g. bowel obdormition, fibroid lung, cerebrovascular accident, active gastric and duodenum) (4)can't exactly record episodes in diaries, Shoujyou-nisshi |
Related Information
Primary Sponsor | Pharmacy Division of National Cancer Center Hospital |
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Secondary Sponsor | |
Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
Secondary ID(s) |
Contact
public contact | |
Name | Masahito Yonemura |
Address | 5-1-1 Tsukiji,Chuuou-ku,Tokyo,104-0045,Japan Japan |
Telephone | 03-3542-2511 |
myonemur@ncc.go.jp | |
Affiliation | Granisetorn coordinating office Pharmacy Division of National Cancer Center Hospital |
scientific contact | |
Name | Taisuke Hojo , Ph.D |
Address | 5-1-1 Tsukiji,Chuuou-ku,Tokyo,104-0045,Japan Japan |
Telephone | 03-3542-2511 |
Affiliation | National Cancer Center Hospital Pharmacy Division |