Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: June 2, 2006
Last updated: May 31, 2012
Last verified: March 2011

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.

Condition Intervention Phase
Postoperative Nausea and Vomiting
Nausea and Vomiting, Postoperative
Drug: casopitant
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Rates of vomiting and retching after surgery.

Secondary Outcome Measures:
  • Rates of nausea after surgery Blood tests to further characterize safety.

Enrollment: 462
Study Start Date: March 2006
Intervention Details:
    Drug: casopitant
    Other Name: casopitant

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00334152

  Show 64 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline Identifier: NCT00334152     History of Changes
Other Study ID Numbers: NKT102552
Study First Received: June 2, 2006
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
ondansetron hydrochloride
postoperative nausea and vomiting
casopitant mesylate

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Neurokinin-1 Receptor Antagonists
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 25, 2014