- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00982995
Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients (HUM21469)
November 5, 2015 updated by: University of Michigan Rogel Cancer Center
UMCC 2008.048 Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Comprehensive Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient must be at least 18 years old.
- Patient must have a terminal diagnosis, with estimated survival of 6 months or less.
- Patients must have nausea and/or vomiting, not relieved with 1 or more anti-nausea medications. If the patient is treated with an anti-nausea medication, a minimum of 2 hours should pass to ensure that the medication is given a chance to be effective. If there is no relief after 2 hours, then the patient may be treated with palonosetron.
- Patient's medications must be reviewed. Any medications possibly causing nausea should be stopped if possible. For example, if an opiate is suspected of causing nausea, another opiate should be substituted. However, if this is not effective, or if a medication change cannot be made, then the patient would be eligible for this study.
- Patient must be able to understand and sign informed consent
- Patients who have a bowel obstruction that will not be relieved by surgery may be enrolled. This includes patients whose obstruction is technically unresectable, or who are medically too ill to endure a surgery, or who refuse surgical intervention for any reason
Exclusion Criteria:
- Patient has received chemotherapy in the past 28 days.
Assessment of possible causes of the nausea and vomiting should be done and recorded. If a reversible cause of the nausea is identified, that cause should be treated if possible. If the treatment relieves the nausea, then the patient is excluded from this study. Possible reversible causes of nausea and vomiting that should be excluded are:
- Other medical conditions such as benign positional vertigo, etc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Palonosetron
Palonosetron 0.25 mg I.V. bolus
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To Determine the Complete Response (no Vomiting and no Need for Nausea Rescue Medication) in Terminally Ill Patients Suffering From Nausea and/or Vomiting, Treated With Palonosetron.
Time Frame: 96 hours after dosing
|
96 hours after dosing
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To Determine the Partial Response (Relief of Nausea and Vomiting to the Extent That the Patient Desires Continued Dosing With Palonosetron,) in Terminally Ill Patients Suffering From Nausea and/or Vomiting, Treated With Palonosetron
Time Frame: 96 hours after dosing
|
96 hours after dosing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
September 21, 2009
First Submitted That Met QC Criteria
September 22, 2009
First Posted (Estimate)
September 23, 2009
Study Record Updates
Last Update Posted (Estimate)
December 4, 2015
Last Update Submitted That Met QC Criteria
November 5, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Serotonin Agents
- Serotonin Antagonists
- Serotonin 5-HT3 Receptor Antagonists
- Palonosetron
Other Study ID Numbers
- UMCC 2008.048
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Instituto Nacional de Cancer, BrazilCompletedPostoperative Nausea and VomitingBrazil
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Joseph MaTerminatedChemotherapy Induced Nausea Vomiting