A double-blind randomized controlled trial comparing 3mg and 1mg of ranisetron for the control of chemotherapy-induced acute emesis
Phase 3
- Conditions
- Malignant tumor (breast cancer, lung cancer, gastric cancer, esophagus cancer, colorectal cancer, etc)
- Registration Number
- JPRN-UMIN000000984
- Lead Sponsor
- Pharma Valley Center, Shizuoka Organization for Creation Industries
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 360
Inclusion Criteria
Not provided
Exclusion Criteria
(1)patients with history of hypersensitivity to 5-HT3 receptor antagonist and corticosteroids (2)patient who do not have enough whole body state to the antineoplastic agents treatment (3)pregnant or expecting woman (4)patient who enforces radiotherapy in the abdomen on the day of chemotherapy (5)uncontrollable diabetes mellitus (6)hepatitis B or C virus Carrier (7)patients having a clear vomiting symptom such as brain metastasis or obstruction to the passage of foods (8)the patient who judged inappropriate as an object of this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method complete protection from vomiting within 24 hours
- Secondary Outcome Measures
Name Time Method 1) Degree of nausea within 24 hours 2) Time to vomiting expression within 24 hours 3)The number of vomiting 4)Degree of nausea in the delayed phase 5)The change of the stool frequency