Postoperative Nausea and VomitingPhase 2NCT00274690
Post-Operative Nausea And Vomiting Study In Female Patients
A Phase 2 study testing GW679769 in people with Postoperative Nausea and Vomiting and Nausea and Vomiting, Postoperative, run by GlaxoSmithKline at 44 sites in 11 countries.
Trial summary
The primary purpose of this study is to determine an effective dose of this NK-1 anti-emetic medication to prevent nausea and vomiting in females after surgery. 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?
- GW679769
- How many people
- 435 participants
- Where
- 44 sitesin 11 countries
- Study dates
- Feb 2005to Aug 2005
- 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, specified risk factors for PONV (post operative nausea and vomiting)
- Undergoing gynecologic or gallbladder surgery.
Who cannot join
- pregnant or breastfeeding
- post-menopausal
Trial locations and contacts
44 sites in 11 countries.
44 sites in 11 countries
United States11 sites
GSK Investigational Site
Camden, New Jersey, 08103-1489
GSK Investigational Site
Chicago, Illinois, 60637
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Grand Rapids, Michigan, 49525
GSK Investigational Site
Melbourne, Florida, 32901
GSK Investigational Site
Royal Oak, Michigan, 48073
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Francisco, California, 94115
GSK Investigational Site
Seattle, Washington, 98195
GSK Investigational Site
West Palm Beach, Florida, 33409
GSK Investigational Site
Winston-Salem, North Carolina, 27103
United Kingdom6 sites
GSK Investigational Site
Edinburgh, Midlothian, EH16 4SA
GSK Investigational Site
Glasgow, Lanarkshire, G11 6NT
GSK Investigational Site
Glasgow, Lanarkshire, G42 9TY
GSK Investigational Site
Glasgow, Lanarkshire, G51 4TF
GSK Investigational Site
Hull, HU16 5JD
GSK Investigational Site
Livingston, West Lothian, EH54 6PP
Hong Kong5 sites
GSK Investigational Site
Lai Chi Kok
GSK Investigational Site
Pokfulam
GSK Investigational Site
Shamshuipo, Kowloon
GSK Investigational Site
Shatin, New Territories
GSK Investigational Site
Tuenmen
Spain4 sites
GSK Investigational Site
Badalona(Barcelona), 08916
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Pamplona, 31008
Denmark3 sites
GSK Investigational Site
Copenhagen, 2100 Ø
GSK Investigational Site
Glostrup Municipality, 2600
GSK Investigational Site
Viborg, 8800
Hungary3 sites
GSK Investigational Site
Budapest, 1115
GSK Investigational Site
Budapest, 1124
GSK Investigational Site
Szentes, 6600
Norway3 sites
GSK Investigational Site
Gjettum, N-1346
GSK Investigational Site
Oslo, N-0407
GSK Investigational Site
Skien, N-3710
Slovenia3 sites
GSK Investigational Site
Ljubljana, SI-1000
GSK Investigational Site
Novo Mesto, 8000
GSK Investigational Site
Slovenj Gradec, 2380
Israel2 sites
GSK Investigational Site
Kfar Saba, 44281
GSK Investigational Site
Tel HaShomer, 52621
Philippines2 sites
GSK Investigational Site
Manila, 1000
GSK Investigational Site
Manila, 1003
Thailand2 sites
GSK Investigational Site
Bangkok, 10330
GSK Investigational Site
Bangkok, 10700
About this study
Official title: A Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety and Efficacy of Oral Dosing With GW679769 (50 mg or 150 mg) for Three Consecutive Days When Administered With a Single Intravenous Dose of 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 Post-operative Nausea and Vomiting Who Are Undergoing Laparoscopic/Laparotomic Surgical Procedures Associated With an Increased Emetogenic Risk
The primary purpose of this study is to determine an effective dose of this NK-1 anti-emetic medication to prevent nausea and vomiting in females after surgery.
Read the detailed description
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety and Efficacy of Oral Dosing with GW679769 (50 mg or 150 mg) for Three Consecutive Days When Administered with a Single Intravenous Dose of 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 Post-operative Nausea and Vomiting Who are Undergoing Laparoscopic/Laparotomic Surgical Procedures Associated with an Increased Emetogenic Risk
- Being tested
- GW679769
- Keywords
- Neurokinin-1 Receptor Antagonist, GW679769, Post-operative Nausea, NK-1 Receptor Antagonist, PONV, Post-discharge Nausea and Vomiting, PDNV, Vomiting
- 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.
GW679769Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, & no premature discontinuation from the study) during the first 72 hr evaluation period following the emergence from anesthesia.
Measured: 72 Hours
Secondary outcomes (1)
The proportion of subjects who achieve a complete response during each subsequent 24-hr eval period (up to 120 hrs) following the emergence from anesthesia.
Measured: 120 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study startFeb 2005
- Primary completionAug 2005
- Study completionAug 2005
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
- 435 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
- NCT00274690
- Sponsor's protocol ID
- NKT102245
- Status last verified
- Jan 2017
- First submitted
- 9 Jan 2006
- 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
- A Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety and Efficacy of Oral Dosing With GW679769 (50 mg or 150 mg) for Three Consecutive Days When Administered With a Single Intravenous Dose of 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 Post-operative Nausea and Vomiting Who Are Undergoing Laparoscopic/Laparotomic Surgical Procedures Associated With an Increased Emetogenic Risk
- ClinicalTrials.gov ID
- NCT00274690
- Acronym / sponsor ID
- NKT102245
- Keywords
- Neurokinin-1 Receptor Antagonist, GW679769, Post-operative Nausea, NK-1 Receptor Antagonist, PONV, Post-discharge Nausea and Vomiting, PDNV, Vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 11 Jan 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.
The primary purpose of this study is to determine an effective dose of this NK-1 anti-emetic medication to prevent nausea and vomiting in females after surgery.
Detailed description
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety and Efficacy of Oral Dosing with GW679769 (50 mg or 150 mg) for Three Consecutive Days When Administered with a Single Intravenous Dose of 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 Post-operative Nausea and Vomiting Who are Undergoing Laparoscopic/Laparotomic 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, specified risk factors for PONV (post operative nausea and vomiting)
- Undergoing gynecologic or gallbladder surgery.
Key exclusion criteria (2 listed)
- pregnant or breastfeeding
- post-menopausal
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 | Drug | – |
Primary outcome
The proportion of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, & no premature discontinuation from the study) during the first 72 hr evaluation period following the emergence from anesthesia.
Time frame: 72 Hours
1 secondary outcome
The proportion of subjects who achieve a complete response during each subsequent 24-hr eval period (up to 120 hrs) following the emergence from anesthesia.
Time frame: 120 Hours
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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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
44 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW679769 in people with Postoperative Nausea and Vomiting and Nausea and Vomiting, Postoperative, run by GlaxoSmithKline at 44 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 2 inclusion and 2 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 44 sites in United States, United Kingdom, Hong Kong, Spain, Denmark 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 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 proportion of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, & no premature discontinuation from the study) during the first 72 hr evaluation period following the emergence from anesthesia. (time frame: 72 Hours). 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.