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
|
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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 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1 | Drug: GW679769 (casopitant) |
- Rates of vomiting and retching [ Time Frame: after surgery ]
- Rates of nausea. Blood test results. [ Time Frame: after surgery ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts 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.

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

Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

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 |