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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| casopitant | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Fairhope | Alabama | 36532 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| NKT102552 | Dataset Specification | View IPD |
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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 10, 2017 | |
| Reset | Dec 1, 2017 | |
| Release | Dec 18, 2017 |
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| 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. | Up to 48 hours |
| Number of participants with first emetic event | Up to 48 hours |
| Number of participants with first antiemetic rescue medication | Up to 48 hours |
| Participant satisfaction with the prophylactic antiemetic regimens, as assessed by participant satisfaction assessments in the participant diary | 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 | Up to 48 hours |
| Number of participants with chemistry data outside the reference range | Up to 48 hours |
| Number of participants with hematology data outside the reference range | 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) | 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. | Up to Days 6-14 visit |
| Mobile |
| Alabama |
| 36608 |
| United States |
| GSK Investigational Site | Montgomery | Alabama | 36106 | United States |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | United States |
| GSK Investigational Site | Arcadia | California | 91007 | United States |
| GSK Investigational Site | Glendale | California | 91206 | United States |
| GSK Investigational Site | Laguna Hills | California | 92653 | United States |
| GSK Investigational Site | Pasadena | California | 91105 | United States |
| GSK Investigational Site | Boca Raton | Florida | 33067 | United States |
| GSK Investigational Site | Melbourne | Florida | 32901 | United States |
| GSK Investigational Site | Miami | Florida | 33143 | United States |
| GSK Investigational Site | West Palm Beach | Florida | 33409 | United States |
| GSK Investigational Site | Chicago | Illinois | 60637 | United States |
| GSK Investigational Site | Kansas City | Kansas | 66160 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21229-5299 | United States |
| GSK Investigational Site | Royal Oak | Michigan | 48073 | United States |
| GSK Investigational Site | Mineola | New York | 11501 | United States |
| GSK Investigational Site | New Hyde Park | New York | 11040 | United States |
| GSK Investigational Site | New York | New York | 10038 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45208 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| GSK Investigational Site | Charlottesville | Virginia | 22908 | United States |
| GSK Investigational Site | Winchester | Virginia | 22601 | United States |
| GSK Investigational Site | Seattle | Washington | 98195 | United States |
| GSK Investigational Site | Aalst | 9300 | Belgium |
| GSK Investigational Site | Brasschaat | 2930 | Belgium |
| GSK Investigational Site | Brussels | 1200 | Belgium |
| GSK Investigational Site | Ghent | 9000 | Belgium |
| GSK Investigational Site | Toronto | Ontario | M5G 1X5 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5G 2M9 | Canada |
| GSK Investigational Site | Sainte-Foy | Quebec | G1V 4G2 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1H 5N4 | Canada |
| GSK Investigational Site | Brno | 625 00 | Czechia |
| GSK Investigational Site | Jihlava | 586 01 | Czechia |
| GSK Investigational Site | Olomouc | 775 20 | Czechia |
| GSK Investigational Site | Pardubice | 532 03 | Czechia |
| GSK Investigational Site | Prague | 128 51 | Czechia |
| GSK Investigational Site | Prague | 150 08 | Czechia |
| GSK Investigational Site | Freiburg im Breisgau | Baden-Wurttemberg | 79110 | Germany |
| GSK Investigational Site | Marburg | Hesse | 35043 | Germany |
| GSK Investigational Site | Neubrandenburg | Mecklenburg-Vorpommern | 17036 | Germany |
| GSK Investigational Site | Rostock | Mecklenburg-Vorpommern | 18059 | Germany |
| GSK Investigational Site | Schwerin | Mecklenburg-Vorpommern | 19055 | Germany |
| GSK Investigational Site | Wismar | Mecklenburg-Vorpommern | 23966 | Germany |
| GSK Investigational Site | Ludwigshafen am Rhein | Rhineland-Palatinate | 67063 | Germany |
| GSK Investigational Site | Homburg | Saarland | 66421 | Germany |
| GSK Investigational Site | Halle | Saxony-Anhalt | 06120 | Germany |
| GSK Investigational Site | Kiel | Schleswig-Holstein | 24105 | Germany |
| GSK Investigational Site | Kwun Tong | Hong Kong |
| GSK Investigational Site | Pokfulam | Hong Kong |
| GSK Investigational Site | Shatin, New Territories | Hong Kong |
| GSK Investigational Site | Sheung Shui, New Territories | Hong Kong |
| GSK Investigational Site | Lahore | Pakistan |
| GSK Investigational Site | Manila | 1000 | Philippines |
| GSK Investigational Site | Quezon City | 1104 | Philippines |
| GSK Investigational Site | Moscow | 101000 | Russia |
| GSK Investigational Site | Moscow | 111538 | Russia |
| GSK Investigational Site | Moscow | 117152 | Russia |
| GSK Investigational Site | Perm | 614107 | Russia |
| GSK Investigational Site | Saint Petersburgh | 192242 | Russia |
| GSK Investigational Site | A Coruña | 15006 | Spain |
| GSK Investigational Site | Badalona | 08916 | Spain |
| GSK Investigational Site | Barcelona | 08003 | Spain |
| GSK Investigational Site | Barcelona | 08025 | Spain |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Mataró | 08034 | Spain |
| GSK Investigational Site | Pamplona | 31008 | Spain |
| GSK Investigational Site | Santiago de Compostela | 15706 | Spain |
| GSK Investigational Site | Bangkok | Thailand |
For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102552 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102552 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102552 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102552 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102552 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102552 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 10, 2017 | Dec 1, 2017 | |||
| Dec 18, 2017 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
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| ID | Term |
|---|---|
| C531951 | casopitant |
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