ONO-7436 Phase II Study in Japan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00212602
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 14, 2012
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

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

Condition or disease Intervention/treatment Phase
Malignant Tumor Drug: ONO-7436 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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
Study Start Date : August 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Patient proportion of complete response (no vomiting and no rescue treatment).

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00212602

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, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Study Director: Project Leader, Development Planning Ono Pharmaceutical Co. Ltd

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ono Pharmaceutical Co. Ltd Identifier: NCT00212602     History of Changes
Other Study ID Numbers: ONO-7436-01
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-7436, Aprepitant, Vomiting, Nausea

Additional relevant MeSH terms:
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action