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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


Phase 2
20 Years
N/A
Not Enrolling
Both
Malignant Tumor

Thank you

Trial Information

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


Inclusion Criteria:



1. Patients age 20 years or older

2. Patients with malignant tumor who are to be intravenously administered cisplatin as a
single dose of 70 mg/m2 or more in under 3 hours

3. Patients whose performance status is 0 to 2

4. Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

1. In case of patients who are previously treated with cisplatin, those having no past
history of vomiting as of administration of cisplatin

2. Patients who had vomiting or dry vomiting within 24 hours before the initial
administration of the moderate or severe emetic chemotherapy (including cisplatin) on
Day 1 of the study

3. Pregnant women, nursing women, women of child-bearing potential, women who wish to
become pregnant or women using oral contraception

4. Other exclusion criteria as specified in the study protocol

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Patient proportion of complete response (no vomiting and no rescue treatment).

Principal Investigator

Project Leader, Development Planning

Investigator Role:

Study Director

Investigator Affiliation:

Ono Pharmaceutical Co. Ltd

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

ONO-7436-01

NCT ID:

NCT00212602

Start Date:

August 2005

Completion Date:

Related Keywords:

  • Malignant Tumor
  • ONO-7436, Aprepitant, Vomiting, Nausea
  • Neoplasms

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