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Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting

NCT01481831 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 599

Last updated 2012-12-31

No results posted yet for this study

Summary

This purpose of this study is to evaluate the efficacy and safety of single and repeated doses of palonosetron hydrochloride in preventing nausea and vomiting caused by moderate and highly emetogenic chemotherapy in patients.

Conditions

  • Neoplasms
  • Chemotherapy-Induced Nausea and Vomiting

Interventions

DRUG

Palonosetron Hydrochloride

0.25 mg IV\*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.

DRUG

Palonosetron Hydrochloride

0.25mg IV\*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.

Sponsors & Collaborators

  • JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd

    collaborator UNKNOWN

  • Shanghai Changzheng Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01481831 on ClinicalTrials.gov