Status:
COMPLETED
Palonosetron in Moderately and Highly Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04935)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Neoplasms
Nausea
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 moderat...
Eligibility Criteria
Inclusion
- Patients must be 18 years of age or older.
- Histological or cytological confirmation of malignant disease.
- Karnofsky index \>= 50%
- Naïve to chemotherapy (First Cycle of chemotherapy IV with moderate or high emetic risk administered during Day 1 of the study, according to modification of the classification of Paul Hesketh's schema published on Annals of Oncology 17: 20-28, 2006 (Appendix 3).
- Patients that voluntarily sign the consent form.
Exclusion
- Pregnancy or suspected.
- Patients during breast feeding.
- Inability to understand or cooperate with the study procedures.
- Received any investigational drugs within 30 days before study entry.
- Received any drug with potential anti-emetic efficacy within 24 hours prior to the beginning of the treatment
- Seizure disorders requiring anticonvulsant medication.
- Persistent vomiting due to any organic etiology.
- Experienced any vomiting, nausea or retching, in the 24 hours prior to chemotherapy.
- Any systemic disease different to base disease
- Known current or history of drug or alcohol abuse
- Gastric outlet or intestinal obstruction
Key Trial Info
Start Date :
April 11 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2008
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00684463
Start Date
April 11 2007
End Date
February 22 2008
Last Update
May 16 2017
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