Postoperative Nausea and VomitingPhase 2NCT00600990
Study Of An NK-1 Anti-Emetic Medication For The Prevention Of Post-Operative Nausea And Vomiting In Female Patients
A Phase 2 study testing GW597599 in people with Postoperative Nausea and Vomiting and Nausea and Vomiting, Postoperative, run by GlaxoSmithKline at 55 sites in 12 countries.
Trial summary
The purpose of this study is to determine the effectiveness of this medication in preventing nausea and vomiting in female patients at risk for post-operative nausea and vomiting (PONV). Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting, Nausea and Vomiting, Postoperative
- What is being tested?
- GW597599
- How many people
- 624 participants
- Where
- 55 sitesin 12 countries
- Study dates
- Dec 2004to Jul 2006
- Phase
- Phase 2
- 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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- known risk factors for PONV.
- Undergoing gynecological or gallbladder surgery.
Who cannot join
None listed.
Trial locations and contacts
55 sites in 12 countries.
55 sites in 12 countries
United States17 sites
GSK Investigational Site
Albany, New York, 12208
GSK Investigational Site
Boca Raton, Florida, 33067
GSK Investigational Site
Chicago, Illinois, 60611
GSK Investigational Site
Dallas, Texas, 75390-9135
GSK Investigational Site
Durham, North Carolina, 27710
GSK Investigational Site
Glendale, California, 91206
GSK Investigational Site
Houston, Texas, 77024
GSK Investigational Site
Laguna Hills, California, 95660
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Los Angeles, California, 90089
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
Omaha, Nebraska, 68131
GSK Investigational Site
Pasadena, California, 91109
GSK Investigational Site
Philadelphia, Pennsylvania, 19141
GSK Investigational Site
Raleigh, North Carolina, 27609
GSK Investigational Site
Spokane, Washington, 99204
Canada8 sites
GSK Investigational Site
Chandler, Quebec, G0C 1K0
GSK Investigational Site
Charlottetown, Prince Edward Island, C1A 8T5
GSK Investigational Site
Greater Sudbury, Ontario, P3E 5V9
GSK Investigational Site
Halifax, Nova Scotia, B3H 2Y9
GSK Investigational Site
Kingston, Ontario, K7L 2V7
GSK Investigational Site
Oshawa, Ontario, L1G 2B9
GSK Investigational Site
Regina, Saskatchewan, S4P 0W5
GSK Investigational Site
Victoria, British Columbia, V8Z 6R5
Australia6 sites
GSK Investigational Site
Carlton, Victoria, 3186
GSK Investigational Site
Melbourne, Victoria, 3004
GSK Investigational Site
Ringwood East, Victoria, 3128
GSK Investigational Site
St Leonards, New South Wales, 2065
GSK Investigational Site
Subiaco, Western Australia, 6008
GSK Investigational Site
Westmead, New South Wales, 2145
Belgium4 sites
GSK Investigational Site
Brussels, 1070
GSK Investigational Site
Brussels, 1200
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Leuven, 3000
Czechia4 sites
GSK Investigational Site
Brno, 625 00
GSK Investigational Site
Jihlava, 586 33
GSK Investigational Site
Olomouc, 775 20
GSK Investigational Site
Ostrava - Poruba, 708 52
Netherlands3 sites
GSK Investigational Site
Roosendaal, 4708 AE
GSK Investigational Site
Rotterdam, 3011 TD
GSK Investigational Site
Rotterdam, 3083 AN
Poland3 sites
GSK Investigational Site
Poznan, 60-535
GSK Investigational Site
Warsaw, 02-507
GSK Investigational Site
Warsaw, 02-781
Chile2 sites
GSK Investigational Site
Santiago, Región Metro de Santiago, 7571831
GSK Investigational Site
Santiago, Región Metro de Santiago, 8380456
Finland2 sites
GSK Investigational Site
Helsinki, 00029
GSK Investigational Site
Kuopio, 70210
South Africa2 sites
GSK Investigational Site
Arcadia, Pretoria, 0083
GSK Investigational Site
Bloemfontein, 9301
Turkey (Türkiye)2 sites
GSK Investigational Site
Istanbul, 34303
GSK Investigational Site
Istanbul
United Kingdom2 sites
GSK Investigational Site
Chelmsford, Essex, CM1 7ET
GSK Investigational Site
Northampton, Northamptonshire, NN1 5BD
About this study
Official title: Phase II Multicenter, Dose Ranging Study on the Safety and Antiemetic Efficacy of One Day Intraveous Dosing of GW597599 Administered With Ondansetron HCL in a Female Subjects Undergoing Surgical Procedures of High Emetogenic Risk
The purpose of this study is to determine the effectiveness of this medication in preventing nausea and vomiting in female patients at risk for post-operative nausea and vomiting (PONV).
Read the detailed description
A Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Oral (25 mg) and Intravenous (3 mg and 18 mg) Formulations of the Neurokinin-1 Receptor Antagonist, GW597599, When Administered with Intravenous Ondansetron Hydrochloride for the Prevention of Post-operative Nausea and Vomiting and Post-discharge Nausea and Vomiting in Female Subjects with Known Risk Factors for PONV Who are Undergoing Surgical Procedures Associated with an Increased Emetogenic Risk
- Being tested
- GW597599
- Keywords
- post-operative nausea and vomiting, PONV
- Medical subject headings
- Postoperative Nausea and Vomiting, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW597599Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects who achieve a complete antiemetic response during the first 24 hour evaluation period following the emergence from anesthesia.
Secondary outcomes (1)
The number of subjects who achieve a complete antiemetic response during each subsequent 24 hour evaluation period (up to 120 hours) following the emergence from anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startDec 2004
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 624 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
- NCT00600990
- Sponsor's protocol ID
- NKO101287
- Status last verified
- Jan 2017
- First submitted
- 15 Jan 2008
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter, Dose Ranging Study on the Safety and Antiemetic Efficacy of One Day Intraveous Dosing of GW597599 Administered With Ondansetron HCL in a Female Subjects Undergoing Surgical Procedures of High Emetogenic Risk
- ClinicalTrials.gov ID
- NCT00600990
- Acronym / sponsor ID
- NKO101287
- Keywords
- post-operative nausea and vomiting, PONV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 624 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 25 Jan 2008 (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.
The purpose of this study is to determine the effectiveness of this medication in preventing nausea and vomiting in female patients at risk for post-operative nausea and vomiting (PONV).
Detailed description
A Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Oral (25 mg) and Intravenous (3 mg and 18 mg) Formulations of the Neurokinin-1 Receptor Antagonist, GW597599, When Administered with Intravenous Ondansetron Hydrochloride for the Prevention of Post-operative Nausea and Vomiting and Post-discharge Nausea and Vomiting in Female Subjects with Known Risk Factors for PONV Who are Undergoing Surgical Procedures Associated with an Increased Emetogenic Risk
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- known risk factors for PONV.
- Undergoing gynecological or gallbladder surgery.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| GW597599 | Drug | – |
Primary outcome
The number of subjects who achieve a complete antiemetic response during the first 24 hour evaluation period following the emergence from anesthesia.
1 secondary outcome
The number of subjects who achieve a complete antiemetic response during each subsequent 24 hour evaluation period (up to 120 hours) following the emergence from anesthesia.
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 20 Jan 2017.
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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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
55 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW597599 in people with Postoperative Nausea and Vomiting and Nausea and Vomiting, Postoperative, run by GlaxoSmithKline at 55 sites in 12 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 2 inclusion and 0 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 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Canada, Australia, Belgium, Czechia and 7 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The number of subjects who achieve a complete antiemetic response during the first 24 hour evaluation period following the emergence from anesthesia.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2017.