Nausea and Vomiting, PostoperativePhase 3NCT00334152
Casopitant And ZOFRAN To Prevent Post Operative Nausea And Vomiting In Women
A Phase 3 study testing casopitant in people with Nausea and Vomiting, Postoperative and Postoperative Nausea and Vomiting, run by GlaxoSmithKline at 70 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, Postoperative Nausea and Vomiting
- What is being tested?
- casopitant
- How many people
- 515 participants
- Where
- 70 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 (postoperative nausea and vomiting) and/or motion sickness.
- Have not smoked for the last 6 months.
- Having certain abdominal, breast, thyroid or shoulder surgery.
Who cannot join
- Pregnant or breastfeeding.
- Have certain pre-existing medical conditions or take certain medications.
Trial locations and contacts
70 sites in 11 countries.
70 sites in 11 countries
United States25 sites
GSK Investigational Site
Arcadia, California, 91007
GSK Investigational Site
Baltimore, Maryland, 21229-5299
GSK Investigational Site
Boca Raton, Florida, 33067
GSK Investigational Site
Charlottesville, Virginia, 22908
GSK Investigational Site
Chicago, Illinois, 60637
GSK Investigational Site
Cincinnati, Ohio, 45208
GSK Investigational Site
Fairhope, Alabama, 36532
GSK Investigational Site
Glendale, California, 91206
GSK Investigational Site
Kansas City, Kansas, 66160
GSK Investigational Site
Laguna Hills, California, 92653
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Melbourne, Florida, 32901
GSK Investigational Site
Miami, Florida, 33143
GSK Investigational Site
Mineola, New York, 11501
GSK Investigational Site
Mobile, Alabama, 36608
GSK Investigational Site
Montgomery, Alabama, 36106
GSK Investigational Site
New Hyde Park, New York, 11040
GSK Investigational Site
New York, New York, 10038
GSK Investigational Site
Oklahoma City, Oklahoma, 73104
GSK Investigational Site
Pasadena, California, 91105
GSK Investigational Site
Royal Oak, Michigan, 48073
GSK Investigational Site
Seattle, Washington, 98195
GSK Investigational Site
West Palm Beach, Florida, 33409
GSK Investigational Site
Winchester, Virginia, 22601
GSK Investigational Site
Winston-Salem, North Carolina, 27103
Germany10 sites
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79110
GSK Investigational Site
Halle, Saxony-Anhalt, 06120
GSK Investigational Site
Homburg, Saarland, 66421
GSK Investigational Site
Kiel, Schleswig-Holstein, 24105
GSK Investigational Site
Ludwigshafen am Rhein, Rhineland-Palatinate, 67063
GSK Investigational Site
Marburg, Hesse, 35043
GSK Investigational Site
Neubrandenburg, Mecklenburg-Vorpommern, 17036
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18059
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19055
GSK Investigational Site
Wismar, Mecklenburg-Vorpommern, 23966
Spain8 sites
GSK Investigational Site
A Coruña, 15006
GSK Investigational Site
Badalona, 08916
GSK Investigational Site
Barcelona, 08003
GSK Investigational Site
Barcelona, 08025
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Mataró, 08034
GSK Investigational Site
Pamplona, 31008
GSK Investigational Site
Santiago de Compostela, 15706
Czechia6 sites
GSK Investigational Site
Brno, 625 00
GSK Investigational Site
Jihlava, 586 01
GSK Investigational Site
Olomouc, 775 20
GSK Investigational Site
Pardubice, 532 03
GSK Investigational Site
Prague, 128 51
GSK Investigational Site
Prague, 150 08
Russia5 sites
GSK Investigational Site
Moscow, 101000
GSK Investigational Site
Moscow, 111538
GSK Investigational Site
Moscow, 117152
GSK Investigational Site
Perm, 614107
GSK Investigational Site
Saint Petersburgh, 192242
Belgium4 sites
GSK Investigational Site
Aalst, 9300
GSK Investigational Site
Brasschaat, 2930
GSK Investigational Site
Brussels, 1200
GSK Investigational Site
Ghent, 9000
Canada4 sites
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G2
GSK Investigational Site
Sherbrooke, Quebec, J1H 5N4
GSK Investigational Site
Toronto, Ontario, M5G 1X5
GSK Investigational Site
Toronto, Ontario, M5G 2M9
Hong Kong4 sites
GSK Investigational Site
Kwun Tong
GSK Investigational Site
Pokfulam
GSK Investigational Site
Shatin, New Territories
GSK Investigational Site
Sheung Shui, New Territories
Philippines2 sites
GSK Investigational Site
Manila, 1000
GSK Investigational Site
Quezon City, 1104
About this study
Official title: A Phase III Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of the 30 mg Intravenous Formulation of the Neurokinin-1 Receptor Antagonist GW679769 for 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.
- Being tested
- casopitant
- Keywords
- NK-1, antiemetics, casopitant mesylate, postoperative nausea and vomiting, ondansetron hydrochloride, 5HT3, ZOFRAN, PONV
- 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.
casopitantDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who achieved a complete response
Complete response defined as no vomiting or retching and no rescue therapy during the first 24 hours following placement of the last suture/staple. Vomiting defined as the forceful expulsion of gastrointestinal contents through the mouth or nose. Retching defined as the labored, spasmodic, rhythmic contraction of the respiratory and abdominal muscles in an attempt to vomit that is not productive of gastrointestinal contents (also known as "dry heaves"). Study participants who receive antiemetic rescue medication(s) during the initial 24 hours was considered treatment failures.
Measured: Up to 24 hours
Secondary outcomes (10)
The severity of nausea experienced by participants in each cohort during the 2, 6, 24 and 48 hour periods, as assessed by an 11-point, linear, numerical rating scale referred to as a "0-10 Likert scale"
Nausea is defined as a subjectively unpleasant sensation associated with the awareness of the urge to vomit; the desire to vomit without the presence of expulsive muscular movements. Each participant completed a Likert scale at 2, 6, 24 and 48 hours after placement of the last suture/staple. The Likert scale used a range of 0-10, where 0 = no nausea and 10 = nausea as bad as it could be.
Measured: Up to 48 hours
The severity of nausea experienced by participants in each cohort during the 2, 6, 24 and 48 hour periods, as assessed by a categorical scale (none, mild, moderate or severe), as defined in the protocol
Nausea is defined as a subjectively unpleasant sensation associated with the awareness of the urge to vomit; the desire to vomit without the presence of expulsive muscular movements. Each participant completed a categorical scale at 2, 6, 24 and 48 hours after placement of the last suture/staple. In the categorical scale, each participant asked to rate the severity of nausea as, none: no nausea, mild: queasiness/upset stomach that is manageable and minimally (if at all) affects daily activities, moderate: increased queasiness, sometimes with the feeling of having to vomit (but not vomiting), that has a significant negative effect on daily activities (for example, being unable to work, eat and drink, prepare food, care for children or others), severe: feeling sick and vomiting or feeling like you are going to vomit, and unable to perform most daily activities.
Measured: Up to 48 hours
Number of participants with first emetic event
Measured: Up to 48 hours
Number of participants with first antiemetic rescue medication
Measured: Up to 48 hours
Participant satisfaction with the prophylactic antiemetic regimens, as assessed by participant satisfaction assessments in the participant diary
Measured: Up to 48 hours
Participant willingness of participants to use the same treatment regimen for future surgical procedures, as assessed by participant satisfaction assessments in the participant diary
Measured: Up to 48 hours
Number of participants with chemistry data outside the reference range
Measured: Up to 48 hours
Number of participants with hematology data outside the reference range
Measured: Up to 48 hours
Safety and tolerability of the antiemetic regimens, assessed by clinical observation (including time to awakening from anesthesia, defined as ability to respond to a verbal command)
Measured: Up to 24 hours
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. Refer to the general AE/SAE module for a list of AEs and SAEs.
Measured: Up to Days 6-14 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 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.
- 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
- Enrolment
- 515 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
- NCT00334152
- Sponsor's protocol ID
- NKT102552
- Status last verified
- Mar 2017
- First submitted
- 2 Jun 2006
- Last updated
- 23 Mar 2017
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. 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 the 30 mg Intravenous Formulation of the Neurokinin-1 Receptor Antagonist GW679769 for Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis
- ClinicalTrials.gov ID
- NCT00334152
- Acronym / sponsor ID
- NKT102552
- Keywords
- NK-1, antiemetics, casopitant mesylate, postoperative nausea and vomiting, ondansetron hydrochloride, 5HT3, ZOFRAN, PONV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 6 Jun 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
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 (postoperative nausea and vomiting) and/or motion sickness.
- Have not smoked for the last 6 months.
- Having certain abdominal, breast, thyroid or shoulder surgery.
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding.
- Have certain pre-existing medical conditions or take certain medications.
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 |
|---|---|---|
| casopitant | Drug | – |
Primary outcome
Number of participants who achieved a complete response
Time frame: Up to 24 hours
Complete response defined as no vomiting or retching and no rescue therapy during the first 24 hours following placement of the last suture/staple. Vomiting defined as the forceful expulsion of gastrointestinal contents through the mouth or nose. Retching defined as the labored, spasmodic, rhythmic contraction of the respiratory and abdominal muscles in an attempt to vomit that is not productive of gastrointestinal contents (also known as "dry heaves"). Study participants who receive antiemetic rescue medication(s) during the initial 24 hours was considered treatment failures.
10 secondary outcomes
The severity of nausea experienced by participants in each cohort during the 2, 6, 24 and 48 hour periods, as assessed by an 11-point, linear, numerical rating scale referred to as a "0-10 Likert scale"
Time frame: Up to 48 hours
The severity of nausea experienced by participants in each cohort during the 2, 6, 24 and 48 hour periods, as assessed by a categorical scale (none, mild, moderate or severe), as defined in the protocol
Time frame: Up to 48 hours
Number of participants with first emetic event
Time frame: Up to 48 hours
Number of participants with first antiemetic rescue medication
Time frame: Up to 48 hours
Participant satisfaction with the prophylactic antiemetic regimens, as assessed by participant satisfaction assessments in the participant diary
Time frame: Up to 48 hours
Participant willingness of participants to use the same treatment regimen for future surgical procedures, as assessed by participant satisfaction assessments in the participant diary
Time frame: Up to 48 hours
Number of participants with chemistry data outside the reference range
Time frame: Up to 48 hours
Number of participants with hematology data outside the reference range
Time frame: Up to 48 hours
Safety and tolerability of the antiemetic regimens, assessed by clinical observation (including time to awakening from anesthesia, defined as ability to respond to a verbal command)
Time frame: Up to 24 hours
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to Days 6-14 visit
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 23 Mar 2017.
- 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.
Related trials for Nausea and Vomiting, Postoperative
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
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
70 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 casopitant in people with Nausea and Vomiting, Postoperative and Postoperative Nausea and Vomiting, run by GlaxoSmithKline at 70 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 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 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United States, Germany, Spain, Czechia, Russia 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?
Number of participants who achieved a complete response (time frame: Up to 24 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 23 Mar 2017.