Nausea and Vomiting, PostoperativePhase 3NCT00326248
Casopitant (Oral) And ZOFRAN To Prevent Postoperative Nausea And Vomiting In Women
A Phase 3 study testing GW679769 (casopitant) in people with Nausea and Vomiting, Postoperative, run by GlaxoSmithKline at 58 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Nausea and Vomiting, Postoperative
- What is being tested?
- GW679769 (casopitant)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 482 participants
- Where
- 58 sitesin 11 countries
- Study dates
- Mar 2006to Jul 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of PONV and/or motion sickness.
- Have not smoked for the last 6 months.
- Having certain types of abdominal, breast or shoulder surgeries.
Who cannot join
- Pregnant or breastfeeding.
- Taking certain medications.
- Have certain pre-existing medical conditions.
Trial locations and contacts
58 sites in 11 countries.
58 sites in 11 countries
United States26 sites
GSK Investigational Site
Altoona, Pennsylvania, 16602
GSK Investigational Site
Anderson, Indiana, 46011
GSK Investigational Site
Boynton Beach, Florida, 33437
GSK Investigational Site
Grand Rapids, Michigan, 49503
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Jackson, Mississippi, 39202
GSK Investigational Site
Jacksonville, Florida, 32216
GSK Investigational Site
Los Angeles, California, 90033
GSK Investigational Site
Melbourne, Florida, 32901
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
Montgomery, Alabama, 36106
GSK Investigational Site
Naples, Florida, 34108
GSK Investigational Site
New Brunswick, New Jersey, 08901
GSK Investigational Site
New Brunswick, New Jersey, 8903
GSK Investigational Site
New York, New York, 10016
GSK Investigational Site
New York, New York, 10025
GSK Investigational Site
Omaha, Nebraska, 68131
GSK Investigational Site
Pensacola, Florida, 32504
GSK Investigational Site
Philadelphia, Pennsylvania, 19102
GSK Investigational Site
Phoenix, Arizona, 85032
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213
GSK Investigational Site
Pittsburgh, Pennsylvania, 15232
GSK Investigational Site
San Antonio, Texas, 78240
GSK Investigational Site
Sheffield, Alabama, 35660
GSK Investigational Site
Spokane, Washington, 99204
GSK Investigational Site
The Bronx, New York, 10467
France9 sites
GSK Investigational Site
Bordeaux, 33000
GSK Investigational Site
Caen, 14033
GSK Investigational Site
Caen, 14050
GSK Investigational Site
Lyon, 69008
GSK Investigational Site
Lyon, 69288
GSK Investigational Site
Paris, 75970
GSK Investigational Site
Rennes, 35000
GSK Investigational Site
Riom, 63204
GSK Investigational Site
Strasbourg, 67098 cedex
Canada5 sites
GSK Investigational Site
Charlottetown, Prince Edward Island, C1A 8T5
GSK Investigational Site
Edmonton, Alberta, T5H 3V9
GSK Investigational Site
Québec, Quebec, G1L 3L5
GSK Investigational Site
Regina, Saskatchewan, S4P 0W5
GSK Investigational Site
Vancouver, British Columbia, V6Z 1Y6
Hungary4 sites
GSK Investigational Site
Győr, 9023
GSK Investigational Site
Miskolc, 3529
GSK Investigational Site
Székesfehérvár, 8001
GSK Investigational Site
Szentes, 6600
Germany3 sites
GSK Investigational Site
Aachen, North Rhine-Westphalia, 52074
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56073
GSK Investigational Site
Marburg, Hesse, 35043
United Kingdom3 sites
GSK Investigational Site
Glasgow, Lanarkshire, G12 0YN
GSK Investigational Site
Liverpool, L8 7SS
GSK Investigational Site
Livingston, West Lothian, EH54 6PP
Hong Kong2 sites
GSK Investigational Site
Pokfulam
GSK Investigational Site
Shatin, New Territories
Philippines2 sites
GSK Investigational Site
Manila, 1003
GSK Investigational Site
Santa Cruz, Manila, 1003
About this study
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
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.
- Conditions
- Nausea and Vomiting, Postoperative
- Being tested
- GW679769 (casopitant)
- Keywords
- postoperative nausea and vomiting PONV antiemetics NK-1 5HT3 casopitant mesylate ZOFRAN ondansetron hydrochloride
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW679769 (casopitant)Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: GW679769 (casopitant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of vomiting and retching
Measured: after surgery
Secondary outcomes (1)
Rates of nausea. Blood test results.
Measured: after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2006 (estimated)
- Study startMar 2006
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nausea and Vomiting, PostoperativeStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326248
- Sponsor's protocol ID
- NKT102553
- Status last verified
- Oct 2016
- First submitted
- 12 May 2006
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Altorjay A, Melson T, Chinachoit T, Kett A, Aqua K, Levin J, Blackburn LM, Lane S, Pergolizzi JV Jr. Casopitant and ondansetron for postoperative nausea and vomiting prevention in women at high risk for emesis: a phase 3 study. Arch Surg. 2011 Feb;146(2):201-6. doi: 10.1001/archsurg.2010.327.
PubMed 21339433
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00326248
- Acronym / sponsor ID
- NKT102553
- Conditions
- Nausea and Vomiting, Postoperative
- Keywords
- postoperative nausea and vomiting PONV antiemetics NK-1 5HT3 casopitant mesylate ZOFRAN ondansetron hydrochloride
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 16 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: GW679769 (casopitant) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of PONV and/or motion sickness.
- Have not smoked for the last 6 months.
- Having certain types of abdominal, breast or shoulder surgeries.
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding.
- Taking certain medications.
- Have certain pre-existing medical conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW679769 (casopitant) | Drug | Arm 1 |
Primary outcome
Rates of vomiting and retching
Time frame: after surgery
1 secondary outcome
Rates of nausea. Blood test results.
Time frame: after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Background: PubMed 21339433Altorjay A, Melson T, Chinachoit T, Kett A, Aqua K, Levin J, Blackburn LM, Lane S, Pergolizzi JV Jr. Casopitant and ondansetron for postoperative nausea and vomiting prevention in women at high risk for emesis: a phase 3 study. Arch Surg. 2011 Feb;146(2):201-6. doi: 10.1001/archsurg.2010.327.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
58 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GW679769 (casopitant) in people with Nausea and Vomiting, Postoperative, run by GlaxoSmithKline at 58 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, France, Canada, Hungary, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of vomiting and retching (time frame: after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00326248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.