ONO-7436 Phase II Study in Japan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Malignant Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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ONO-7436

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No