ONO-7436 Phase II Study in Japan - Full Text View

Sponsored by:	Ono Pharma
Information provided by:	Ono Pharma
ClinicalTrials.gov Identifier:	NCT00212602

Purpose

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

Condition	Intervention	Phase
Malignant Tumor	Drug: ONO-7436	Phase II

MedlinePlus related topics: Cancer Nausea and Vomiting

Drug Information available for: Aprepitant

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Ono Pharma:

Primary Outcome Measures:

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

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.

Estimated Enrollment:	420
Study Start Date:	August 2005

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212602

Locations

Japan
Hokkaido Region Facility
Hokkaido, Japan
Kanto Region Facility
Kanto, Japan
Hokuriku Region Facility
Hokuriku, Japan
Chubu Region Facility
Chubu, Japan
Tohoku Region Facility
Tohoku, Japan
Chugoku Region Facility
Chugoku, Japan
Shikoku Region Facility
Shikoku, Japan
Kyushu Region Facility
Kyushu, Japan
Kinki Region Facility
Kinki, Japan

Sponsors and Collaborators

Ono Pharma

Investigators

Study Director:

Project Leader, Development Planning

Ono Pharma

More Information

Study ID Numbers:	ONO-7436-01
Study First Received:	September 13, 2005
Last Updated:	September 14, 2006
ClinicalTrials.gov Identifier:	NCT00212602
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharma:

ONO-7436, Aprepitant, Vomiting, Nausea

Study placed in the following topic categories:

Vomiting
Nausea
Aprepitant

Additional relevant MeSH terms:

Neoplasms
Autonomic Agents
Therapeutic Uses
Physiological Effects of Drugs
Gastrointestinal Agents

Antiemetics
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009