Nausea and Vomiting, Postoperative, Postoperative Nausea and Vomiting
Conditions
Keywords
NK-1, antiemetics, casopitant mesylate, postoperative nausea and vomiting, ondansetron hydrochloride, 5HT3, ZOFRAN, PONV
Brief summary
This study is being conducted to see if adding GW679769 (casopitant) to ZOFRAN will significantly decrease the number of patients who experience nausea and vomiting after surgery.
Interventions
DRUGcasopitant
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of PONV (postoperative nausea and vomiting) and/or motion sickness. * Have not smoked for the last 6 months. * Having certain abdominal, breast, thyroid or shoulder surgery.
Exclusion criteria
* Pregnant or breastfeeding. * Have certain pre-existing medical conditions or take certain medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who achieved a complete response | Up to 24 hours | Complete response defined as no vomiting or retching and no rescue therapy during the first 24 hours following placement of the last suture/staple. Vomiting defined as the forceful expulsion of gastrointestinal contents through the mouth or nose. Retching defined as the labored, spasmodic, rhythmic contraction of the respiratory and abdominal muscles in an attempt to vomit that is not productive of gastrointestinal contents (also known as dry heaves). Study participants who receive antiemetic rescue medication(s) during the initial 24 hours was considered treatment failures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The severity of nausea experienced by participants in each cohort during the 2, 6, 24 and 48 hour periods, as assessed by a categorical scale (none, mild, moderate or severe), as defined in the protocol | Up to 48 hours | Nausea is defined as a subjectively unpleasant sensation associated with the awareness of the urge to vomit; the desire to vomit without the presence of expulsive muscular movements. Each participant completed a categorical scale at 2, 6, 24 and 48 hours after placement of the last suture/staple. In the categorical scale, each participant asked to rate the severity of nausea as, none: no nausea, mild: queasiness/upset stomach that is manageable and minimally (if at all) affects daily activities, moderate: increased queasiness, sometimes with the feeling of having to vomit (but not vomiting), that has a significant negative effect on daily activities (for example, being unable to work, eat and drink, prepare food, care for children or others), severe: feeling sick and vomiting or feeling like you are going to vomit, and unable to perform most daily activities. |
| Number of participants with first emetic event | Up to 48 hours | — |
| Number of participants with first antiemetic rescue medication | Up to 48 hours | — |
| Participant satisfaction with the prophylactic antiemetic regimens, as assessed by participant satisfaction assessments in the participant diary | Up to 48 hours | — |
| The severity of nausea experienced by participants in each cohort during the 2, 6, 24 and 48 hour periods, as assessed by an 11-point, linear, numerical rating scale referred to as a 0-10 Likert scale | Up to 48 hours | Nausea is defined as a subjectively unpleasant sensation associated with the awareness of the urge to vomit; the desire to vomit without the presence of expulsive muscular movements. Each participant completed a Likert scale at 2, 6, 24 and 48 hours after placement of the last suture/staple. The Likert scale used a range of 0-10, where 0 = no nausea and 10 = nausea as bad as it could be. |
| Number of participants with chemistry data outside the reference range | Up to 48 hours | — |
| Number of participants with hematology data outside the reference range | Up to 48 hours | — |
| Safety and tolerability of the antiemetic regimens, assessed by clinical observation (including time to awakening from anesthesia, defined as ability to respond to a verbal command) | Up to 24 hours | — |
| Number of participants with adverse events (AEs) and serious adverse events (SAEs) | Up to Days 6-14 visit | An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. Refer to the general AE/SAE module for a list of AEs and SAEs. |
| Participant willingness of participants to use the same treatment regimen for future surgical procedures, as assessed by participant satisfaction assessments in the participant diary | Up to 48 hours | — |
Countries
Belgium, Canada, Czechia, Germany, Hong Kong, Pakistan, Philippines, Russia, Spain, Thailand, United States
Outcome results
None listed