Palonosetron in Moderately and Highly Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04935)(COMPLETED)
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|ClinicalTrials.gov Identifier: NCT00684463|
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : May 16, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
The purpose of this study is to evaluate the efficacy and safety of single IV doses of Onicit® (Palonosetron) 0.25 mg in the prevention of acute and delayed nausea and vomiting associated with moderate and highly emetogenic chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms Nausea Vomiting||Drug: Palonosetron||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study to Evaluate the Efficacy and Safety of Single IV Doses of Onicit® (Palonosetron) 0.25 mg in the Prevention of Acute and Delayed Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in Colombia|
|Actual Study Start Date :||April 11, 2007|
|Actual Primary Completion Date :||February 22, 2008|
|Actual Study Completion Date :||February 22, 2008|
0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent
0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent.
Other Name: SCH 734291 - Onicit®
Primary Outcome Measures :
- Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication. [ Time Frame: During 24 hours after administration of chemotherapy. ]
Secondary Outcome Measures :
- Proportion of patients who achieved a CR and of those who achieved complete control [ Time Frame: Days 1 to 5 at different time intervals for each secondary outcome. ]
- Number of emetic episodes [ Time Frame: Days 1 to 5 at different time intervals for each secondary outcome. ]
- Time to first emetic episode; time to administration and need for rescue therapy; and to treatment failure time to first emetic episode or administration of rescue medication [ Time Frame: Days 1 to 5 at different time intervals for each secondary outcome. ]
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