Palonosetron Plus Dexamethasone in Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04594)
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|ClinicalTrials.gov Identifier: NCT00687011|
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : May 15, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
The purpose of this study is to determine if a single intravenous (IV) dose of palonosetron 0.25 mg plus a single IV dose of dexamethasone 8 mg is effective to prevent nausea and vomiting induced by moderately emetogenic chemotherapy in subjects with cancer.
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms Nausea Vomiting||Drug: Palonosetron and Dexamethasone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||118 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label Clinical Trial to Assess the Efficacy, Tolerability and Safety of a Single IV Dose of Palonosetron 0.25 mg + Dexamethasone IV in the Prevention of Moderately Emetogenic Chemotherapy-induced Nausea and Vomit (CINV).|
|Actual Study Start Date :||October 10, 2006|
|Actual Primary Completion Date :||October 27, 2008|
|Actual Study Completion Date :||October 27, 2008|
Drug: Palonosetron and Dexamethasone
0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent, plus single IV dose of dexamethasone 8 mg administered 15 minutes before chemotherapy (in the event of a shortage of IV dexamethasone, a single oral dose of dexamethasone 20 mg or a single IV dose of methylprednisolone 125 mg could be administered).
Other Name: SCH 734291
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; Number of emetic episodes; Time to first emetic episode, to administration and need for rescue therapy; and to treatment failure [ Time Frame: Days 1 to 5 at different time intervals for each secondary outcome. ]
- Severity of nausea; Patient global satisfaction; Quality of life questionnaire [ Time Frame: Days 1 to 5 at different time intervals for each secondary outcome. ]
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