ONO-7436 Phase II Study in Japan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00212602
First received: September 13, 2005
Last updated: June 12, 2012
Last verified: June 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Ono Pharmaceutical Co. Ltd:

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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided by Ono Pharmaceutical Co. Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00212602     History of Changes
Other Study ID Numbers: ONO-7436-01
Study First Received: September 13, 2005
Last Updated: June 12, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Neoplasms
Aprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 22, 2014