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Casopitant (Oral) And ZOFRAN To Prevent Postoperative Nausea And Vomiting In Women
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00326248
First received: May 12, 2006
Last updated: October 24, 2016
Last verified: October 2016
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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 |
|---|---|---|
| Nausea and Vomiting, Postoperative | Drug: GW679769 (casopitant) | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Rates of vomiting and retching [ Time Frame: after surgery ]
Secondary Outcome Measures:
- Rates of nausea. Blood test results. [ Time Frame: after surgery ]
| Enrollment: | 482 |
| Study Start Date: | March 2006 |
| Study Completion Date: | July 2006 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 | Drug: GW679769 (casopitant) |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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.
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 ClinicalTrials.gov identifier: NCT00326248
Show 58 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326248
Show 58 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Additional Information:
Publications:
Study Data/Documents: Individual Participant Data Set
Identifier: NKT102553
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
Clinical Study Report
Identifier: NKT102553
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
Annotated Case Report Form
Identifier: NKT102553
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
Informed Consent Form
Identifier: NKT102553
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
Statistical Analysis Plan
Identifier: NKT102553
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
Study Protocol
Identifier: NKT102553
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
Dataset Specification
Identifier: NKT102553
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
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00326248 History of Changes |
| Other Study ID Numbers: |
NKT102553 |
| Study First Received: | May 12, 2006 |
| Last Updated: | October 24, 2016 |
| Individual Participant Data | |
| 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 |
ClinicalTrials.gov processed this record on June 23, 2017