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Completed

NCT Number: NCT00212602

ONO-7436 Phase II Study 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

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Key information

Conditions

Malignant Tumor Nausea Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chugoku Region Facility, Chugoku, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-7436

Drug

Primary outcomes

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2005
First posted
Sep 21, 2005
Registry last updated
Jun 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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