Nausea and Vomiting, Chemotherapy-Induced
Conditions
Keywords
Nausea, Vomiting, Emesis, Chemotherapy-induced Nausea and Vomiting, CINV
Brief summary
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.
Detailed description
Phase II Multicentre, Randomised, Double-Blind, Placebo and Active-Controlled, Dose-Ranging, Parallel Group Study of the Safety and Efficacy of The Oral Neurokinin-1 Receptor Antagonist, GW679769 in Combination with Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Highly Emetogenic Cisplatin-based Chemotherapy.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting. | — |
Countries
Argentina, Austria, Belgium, Chile, Croatia, Czechia, Hong Kong, Hungary, Italy, Mexico, Netherlands, Pakistan, Peru, Philippines, Poland, Romania, Singapore, Slovakia, Taiwan
Outcome results
None listed