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Clinical Trials/NCT00334152
NCT00334152CompletedPhase 3

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

GlaxoSmithKline70 sites in 6 countries515 target enrollmentStarted: March 1, 2006Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (70)

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