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Casopitant (Oral) And ZOFRAN To Prevent Postoperative Nausea And Vomiting In Women

A Phase III, Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of 50mg Oral Dosing With the Neurokinin-1 Receptor Antagonist GW679769 for the Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00326248
Enrollment
482
Registered
2006-05-16
Start date
2006-03-31
Completion date
2006-07-31
Last updated
2016-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea and Vomiting, Postoperative

Keywords

postoperative nausea and vomiting PONV antiemetics NK-1 5HT3 casopitant mesylate ZOFRAN ondansetron hydrochloride

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

DRUGGW679769 (casopitant)

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* History of PONV and/or motion sickness. * Have not smoked for the last 6 months. * Having certain types of abdominal, breast or shoulder surgeries.

Exclusion criteria

* Pregnant or breastfeeding. * Taking certain medications. * Have certain pre-existing medical conditions.

Design outcomes

Primary

MeasureTime frame
Rates of vomiting and retchingafter surgery

Secondary

MeasureTime frame
Rates of nausea. Blood test results.after surgery

Countries

Canada, France, Germany, Hong Kong, Hungary, Ireland, Pakistan, Philippines, Thailand, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026