Casopitant And ZOFRAN To Prevent Post Operative Nausea And Vomiting In Women

Postoperative Nausea and Vomiting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334152
• Other study ID #: NKT102552
• 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
• 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.

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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