ONO-7436 Phase II Study in Japan

Malignant Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212602
• Other study ID #: ONO-7436-01
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: June 12, 2012
• Start date: August 2005

Study information

• Verified date: June 2012
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Malignant Tumor
• Neoplasms

Intervention

Drug:
• ONO-7436

Locations

Country	Name	City	State
Japan	Chubu Region Facility	Chubu
Japan	Chugoku Region Facility	Chugoku
Japan	Hokkaido Region Facility	Hokkaido
Japan	Hokuriku Region Facility	Hokuriku
Japan	Kanto Region Facility	Kanto
Japan	Kinki Region Facility	Kinki
Japan	Kyushu Region Facility	Kyushu
Japan	Shikoku Region Facility	Shikoku
Japan	Tohoku Region Facility	Tohoku

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient proportion of complete response (no vomiting and no rescue treatment).
Secondary	Proportion of patients with no vomiting, no rescue treatment, and no nausea (in each category or combination), frequency of vomiting, and time to first vomiting, and first rescue treatment.