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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
History of Changes

September 13, 2005
June 12, 2012
August 2005
Not Provided
Patient proportion of complete response (no vomiting and no rescue treatment).
Same as current
Complete list of historical versions of study NCT00212602 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
ONO-7436 Phase II Study in Japan
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

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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Malignant Tumor
Drug: ONO-7436
Not Provided
Takahashi T, Hoshi E, Takagi M, Katsumata N, Kawahara M, Eguchi K. Multicenter, phase II, placebo-controlled, double-blind, randomized study of aprepitant in Japanese patients receiving high-dose cisplatin. Cancer Sci. 2010 Nov;101(11):2455-61.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
420
Not Provided
Not Provided

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00212602
ONO-7436-01
Not Provided
Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
Not Provided
Study Director: Project Leader, Development Planning Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP