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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00334152
Other study ID # NKT102552
Secondary ID
Status Completed
Phase Phase 3
First received June 2, 2006
Last updated March 21, 2017
Start date March 2006
Est. completion date July 2006

Study information

Verified date March 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 515
Est. completion date July 2006
Est. primary completion date July 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion criteria:

- 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.

Exclusion criteria:

- Pregnant or breastfeeding.

- Have certain pre-existing medical conditions or take certain medications.

Study Design


Related Conditions & MeSH terms

  • Nausea
  • Nausea and Vomiting, Postoperative
  • Postoperative Nausea and Vomiting
  • Vomiting

Intervention

Drug:
casopitant


Locations

Country Name City State
Belgium GSK Investigational Site Aalst
Belgium GSK Investigational Site Brasschaat
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Gent
Canada GSK Investigational Site Sainte-Foy Quebec
Canada GSK Investigational Site Sherbrooke Quebec
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Toronto Ontario
Czech Republic GSK Investigational Site Brno
Czech Republic GSK Investigational Site Jihlava
Czech Republic GSK Investigational Site Olomouc
Czech Republic GSK Investigational Site Pardubice
Czech Republic GSK Investigational Site Praha 2
Czech Republic GSK Investigational Site Praha 5
Germany GSK Investigational Site Freiburg Baden-Wuerttemberg
Germany GSK Investigational Site Halle Sachsen-Anhalt
Germany GSK Investigational Site Homburg Saarland
Germany GSK Investigational Site Kiel Schleswig-Holstein
Germany GSK Investigational Site Ludwigshafen Rheinland-Pfalz
Germany GSK Investigational Site Marburg Hessen
Germany GSK Investigational Site Neubrandenburg Mecklenburg-Vorpommern
Germany GSK Investigational Site Rostock Mecklenburg-Vorpommern
Germany GSK Investigational Site Schwerin Mecklenburg-Vorpommern
Germany GSK Investigational Site Wismar Mecklenburg-Vorpommern
Hong Kong 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
Pakistan GSK Investigational Site Lahore
Philippines GSK Investigational Site Manila
Philippines GSK Investigational Site Quezon, City
Russian Federation GSK Investigational Site Moscow
Russian Federation GSK Investigational Site Moscow
Russian Federation GSK Investigational Site Moscow
Russian Federation GSK Investigational Site Perm
Russian Federation GSK Investigational Site St. Petersburgh
Spain GSK Investigational Site Badalona
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site La Coruña
Spain GSK Investigational Site Mataro
Spain GSK Investigational Site Pamplona
Spain GSK Investigational Site Santiago de Compostela
Thailand GSK Investigational Site Bangkok
United States GSK Investigational Site Arcadia California
United States GSK Investigational Site Baltimore Maryland
United States GSK Investigational Site Boca Raton Florida
United States GSK Investigational Site Charlottesville Virginia
United States GSK Investigational Site Chicago Illinois
United States GSK Investigational Site Cincinnati Ohio
United States GSK Investigational Site Fairhope Alabama
United States GSK Investigational Site Glendale California
United States GSK Investigational Site Kansas City Kansas
United States GSK Investigational Site Laguna Hills California
United States GSK Investigational Site Little Rock Arkansas
United States GSK Investigational Site Melbourne Florida
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Mineola New York
United States GSK Investigational Site Mobile Alabama
United States GSK Investigational Site Montgomery Alabama
United States GSK Investigational Site New Hyde Park New York
United States GSK Investigational Site New York New York
United States GSK Investigational Site Oklahoma City Oklahoma
United States GSK Investigational Site Pasadena California
United States GSK Investigational Site Royal Oak Michigan
United States GSK Investigational Site Seattle Washington
United States GSK Investigational Site West Palm Beach Florida
United States GSK Investigational Site Winchester Virginia
United States GSK Investigational Site Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czech Republic,  Germany,  Hong Kong,  Pakistan,  Philippines,  Russian Federation,  Spain,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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. Up to 48 hours
Secondary 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
Secondary Number of participants with first emetic event Up to 48 hours
Secondary Number of participants with first antiemetic rescue medication Up to 48 hours
Secondary Participant satisfaction with the prophylactic antiemetic regimens, as assessed by participant satisfaction assessments in the participant diary Up to 48 hours
Secondary 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
Secondary Number of participants with chemistry data outside the reference range Up to 48 hours
Secondary Number of participants with hematology data outside the reference range Up to 48 hours
Secondary 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
Secondary 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
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