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

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ClinicalTrials.gov Identifier: NCT00326248
Recruitment Status : Completed
First Posted : May 16, 2006
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Nausea and Vomiting, Postoperative Drug: GW679769 (casopitant) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 482 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official 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
Study Start Date : March 2006
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1 Drug: GW679769 (casopitant)



Primary Outcome Measures :
  1. Rates of vomiting and retching [ Time Frame: after surgery ]

Secondary Outcome Measures :
  1. Rates of nausea. Blood test results. [ Time Frame: after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326248


  Show 58 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: NKT102553
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: NKT102553
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: NKT102553
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: NKT102553
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: NKT102553
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: NKT102553
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: NKT102553
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00326248     History of Changes
Other Study ID Numbers: NKT102553
First Posted: May 16, 2006    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
postoperative nausea and vomiting PONV antiemetics NK-1 5HT3 casopitant mesylate ZOFRAN ondansetron hydrochloride

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Casopitant
Neurokinin-1 Receptor Antagonists
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action