- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00982995
Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients (HUM21469)
5. november 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
3
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan Comprehensive Cancer Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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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.
Tidsramme: 96 hours after dosing
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96 hours after dosing
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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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
Tidsramme: 96 hours after dosing
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96 hours after dosing
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2010
Primær færdiggørelse (Faktiske)
1. maj 2013
Studieafslutning (Faktiske)
1. maj 2013
Datoer for studieregistrering
Først indsendt
21. september 2009
Først indsendt, der opfyldte QC-kriterier
22. september 2009
Først opslået (Skøn)
23. september 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. december 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. november 2015
Sidst verificeret
1. november 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Tegn og symptomer, fordøjelsessystemet
- Kvalme
- Opkastning
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystem
- Antiemetika
- Gastrointestinale midler
- Serotoninmidler
- Serotonin-antagonister
- Serotonin 5-HT3-receptorantagonister
- Palonosetron
Andre undersøgelses-id-numre
- UMCC 2008.048
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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