Last updated: 11/07/2018 17:52:36
Study for The Prevention Of Nausea in Cancer Patients Receiving Highly Emetogenic Cisplatin Based Chemotherapy
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: See Detailed Description
Trial description: This study was designed to assess the safety and efficacy of an investigational agent administered in addition to a standard anti-emetic regimen for the treatment of chemotherapy induced nausea and vomiting.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Aprepitant
Drug: Ondansetron
Drug: GW679769
Drug: Dexamethasone
Enrollment:
492
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Roila F, Rolski J, Ramlau R, Dediu M, Russo MW, Bandekar RR, Grunberg SM. Randomized, double-blind, dose-ranging trial of the oral neurokinin-1 receptor antagonist casopitant mesylate for the prevention of cisplatin-induced nausea and vomiting. Ann Oncol. 2009;20(11): 1867-73.
Medical condition
Nausea and Vomiting, Chemotherapy-Induced
Product
casopitant, ondansetron
Collaborators
Not applicable
Study date(s)
February 2005 to December 2005
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
no
- Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
- Diagnosed with a solid malignant tumour and has not previously received chemotherapy.
- Not received any investigational product within 30 days of enrolment into the study.
- Must not be pregnant.
Inclusion and exclusion criteria
Inclusion criteria:
- Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
- Diagnosed with a solid malignant tumour and has not previously received chemotherapy.
- Scheduled to receive chemotherapy conducive to regimens outlined in the study protocol.
Exclusion criteria:
- Not received any investigational product within 30 days of enrolment into the study.
- Must not be pregnant.
- Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol.
- Must not be scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication.
- Must not be currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction).
- Must not have a history of peptic ulcer disease.
Trial location(s)
Location
GSK Investigational Site
Taft Avenue, Manila, Philippines, 1700
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C1405CBA
Status
Study Complete
Location
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, C1437JCP
Status
Study Complete
Location
GSK Investigational Site
Ostrava - Poruba, Czech Republic, 708 52
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500921
Status
Study Complete
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 05
Status
Study Complete
Location
GSK Investigational Site
Casalpusterlengo (LO), Lombardia, Italy, 26841
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-09-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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