ONO-7436 Phase II Study in Japan - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 13, 2005

Last Updated Date

September 14, 2006

Start Date ^†

August 2005

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00212602 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

ONO-7436 Phase II Study in Japan

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

Brief 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

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Malignant Tumor

Intervention ^†

Drug: ONO-7436

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

420

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Patients age 20 years or older
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
Patients whose performance status is 0 to 2
Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

In case of patients who are previously treated with cisplatin, those having no past history of vomiting as of administration of cisplatin
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
Pregnant women, nursing women, women of child-bearing potential, women who wish to become pregnant or women using oral contraception
Other exclusion criteria as specified in the study protocol

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00212602

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Ono Pharma

Collaborators ^††

Investigators ^†

Study Director:

Project Leader, Development Planning

Ono Pharma

Information Provided By

Ono Pharma

Verification Date

September 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.