A Phase III Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of the 30 mg Intravenous Formulation of the Neurokinin-1 Receptor Antagonist GW679769 for Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 515
- Locations
- 70
- Primary Endpoint
- Number of participants who achieved a complete response
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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.
Outcomes
Primary Outcomes
Number of participants who achieved a complete response
Time Frame: 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 Outcomes
- Participant satisfaction with the prophylactic antiemetic regimens, as assessed by participant satisfaction assessments in the participant diary(Up to 48 hours)
- 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)
- Number of participants with chemistry data outside the reference range(Up to 48 hours)
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)(Up to Days 6-14 visit)
- Number of participants with first antiemetic rescue medication(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)
- 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)
- Number of participants with first emetic event(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)
