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OpenTrials
Completed

NCT Number: NCT00326248

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

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.

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Key information

Conditions

Nausea and Vomiting, Postoperative Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GW679769 (casopitant)

Drug

Primary outcomes

  1. Rates of vomiting and retching

    Time frame: after surgery

Secondary outcomes

  1. Rates of nausea. Blood test results.

    Time frame: after surgery

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
May 16, 2006
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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