A placebo-controlled, double-blind, randomized phase III study to validate the efficacy of standard antiemetic therapy plus olanzapine for the prevention of chemotherapy-induced nausea and vomiting associated with chemotherapy including carboplati
Not Applicable
Recruiting
- Conditions
- Advanced lung cancer
- Registration Number
- JPRN-UMIN000037749
- Lead Sponsor
- Second Division, Department of Internal Medicine, Hamamatsu university school of medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 380
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients with the history of hypersensitivity or allergy for study drugs. 2)Patients who need and use antiemetic therapy during 48h before chemotherapy. 3)Patients with severe hepatic or renal dysfunction. 4)With convulsion. 5)Patients who need puncture to manage ascites. 6)Patients with complications inducing nausea and vomiting. 7)Patients with diabetes mellitus. 8)Patients who are judged to be inappropriate for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response rate during the 120 h after carboplatin administration.
- Secondary Outcome Measures
Name Time Method Complete response rate during the acute, delayed phase. Complete control rate, safety.