NCT00982995

Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients

UMCC 2008.048 Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the complete response (no vomiting and no need for other medications to treat nausea) in terminally ill patients suffering from nausea and/or vomiting, who are treated with palonosetron. Another objective is to determine the partial response (relief of nausea and vomiting to the extent that the patient wishes to continue treatment with palonosetron) after being treated with palonosetron. Palonosetron is currently approved by the FDA to prevent nausea and vomiting associated with chemotherapy. The investigators are testing this medication to see if it can help to relieve nausea and vomiting not associated with chemotherapy.

Conditions

• Nausea
• Vomiting
• Terminally Ill

Interventions

Type	Name	Description
DRUG	Palonosetron	Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief.

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2009-09-23
• Last updated: 2015-12-04
• Results posted: 2014-09-15

Locations

1 site across 1 country: United States