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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00334152
First received: June 2, 2006
Last updated: May 31, 2012
Last verified: March 2011
History of Changes
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334152

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov 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
5HT3
 ZOFRAN
NK-1
PONV
antiemetics

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on October 16, 2012