Casopitant And ZOFRAN To Prevent Post Operative Nausea And Vomiting In Women

Condition(s) targeted: Postoperative Nausea and Vomiting

Intervention: casopitant (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical trials, MD, PhD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: 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

Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Rates of vomiting and retching after surgery.

Secondary outcome: Rates of nausea after surgery Blood tests to further characterize safety.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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.

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Starting date: April 2006
Last updated: August 10, 2007