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

NCT00334152 | Completed Phase 3

• 1 other identifier: NKT102552
• Study Type: interventional
• Target: 515
• Locations: 11 countries
• Sites: 70

Brief 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.

Conditions

Nausea and Vomiting, Postoperative; Postoperative Nausea and Vomiting

Keywords

NK-1; antiemetics; casopitant mesylate; postoperative nausea and vomiting; ondansetron hydrochloride; 5HT3; ZOFRAN; PONV

Outcome Measures

Primary Outcomes (1)

• 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 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"

  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

  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

Interventions

casopitant DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or breastfeeding.
• Have certain pre-existing medical conditions or take certain medications.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (70)

GSK Investigational Site

Fairhope, Alabama, 36532, United States

Location

GSK Investigational Site

Mobile, Alabama, 36608, United States

Location

GSK Investigational Site

Montgomery, Alabama, 36106, United States

Location

GSK Investigational Site

Little Rock, Arkansas, 72205, United States

Location

GSK Investigational Site

Arcadia, California, 91007, United States

Location

GSK Investigational Site

Glendale, California, 91206, United States

Location

GSK Investigational Site

Laguna Hills, California, 92653, United States

Location

GSK Investigational Site

Pasadena, California, 91105, United States

Location

GSK Investigational Site

Boca Raton, Florida, 33067, United States

Location

GSK Investigational Site

Melbourne, Florida, 32901, United States

Location

GSK Investigational Site

Miami, Florida, 33143, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33409, United States

Location

GSK Investigational Site

Chicago, Illinois, 60637, United States

Location

GSK Investigational Site

Kansas City, Kansas, 66160, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21229-5299, United States

Location

GSK Investigational Site

Royal Oak, Michigan, 48073, United States

Location

GSK Investigational Site

Mineola, New York, 11501, United States

Location

GSK Investigational Site

New Hyde Park, New York, 11040, United States

Location

GSK Investigational Site

New York, New York, 10038, United States

Location

GSK Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45208, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73104, United States

Location

GSK Investigational Site

Charlottesville, Virginia, 22908, United States

Location

GSK Investigational Site

Winchester, Virginia, 22601, United States

Location

GSK Investigational Site

Seattle, Washington, 98195, United States

Location

GSK Investigational Site

Aalst, 9300, Belgium

Location

GSK Investigational Site

Brasschaat, 2930, Belgium

Location

GSK Investigational Site

Brussels, 1200, Belgium

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Toronto, Ontario, M5G 1X5, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 2M9, Canada

Location

GSK Investigational Site

Sainte-Foy, Quebec, G1V 4G2, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1H 5N4, Canada

Location

GSK Investigational Site

Brno, 625 00, Czechia

Location

GSK Investigational Site

Jihlava, 586 01, Czechia

Location

GSK Investigational Site

Olomouc, 775 20, Czechia

Location

GSK Investigational Site

Pardubice, 532 03, Czechia

Location

GSK Investigational Site

Prague, 128 51, Czechia

Location

GSK Investigational Site

Prague, 150 08, Czechia

Location

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, 79110, Germany

Location

GSK Investigational Site

Marburg, Hesse, 35043, Germany

Location

GSK Investigational Site

Neubrandenburg, Mecklenburg-Vorpommern, 17036, Germany

Location

GSK Investigational Site

Rostock, Mecklenburg-Vorpommern, 18059, Germany

Location

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

GSK Investigational Site

Wismar, Mecklenburg-Vorpommern, 23966, Germany

Location

GSK Investigational Site

Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany

Location

GSK Investigational Site

Homburg, Saarland, 66421, Germany

Location

GSK Investigational Site

Halle, Saxony-Anhalt, 06120, Germany

Location

GSK Investigational Site

Kiel, Schleswig-Holstein, 24105, Germany

Location

GSK Investigational Site

Kwun Tong, Hong Kong

Location

GSK Investigational Site

Pokfulam, Hong Kong

Location

GSK Investigational Site

Shatin, New Territories, Hong Kong

Location

GSK Investigational Site

Sheung Shui, New Territories, Hong Kong

Location

GSK Investigational Site

Lahore, Pakistan

Location

GSK Investigational Site

Manila, 1000, Philippines

Location

GSK Investigational Site

Quezon City, 1104, Philippines

Location

GSK Investigational Site

Moscow, 101000, Russia

Location

GSK Investigational Site

Moscow, 111538, Russia

Location

GSK Investigational Site

Moscow, 117152, Russia

Location

GSK Investigational Site

Perm, 614107, Russia

Location

GSK Investigational Site

Saint Petersburgh, 192242, Russia

Location

GSK Investigational Site

A Coruña, 15006, Spain

Location

GSK Investigational Site

Badalona, 08916, Spain

Location

GSK Investigational Site

Barcelona, 08003, Spain

Location

GSK Investigational Site

Barcelona, 08025, Spain

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Mataró, 08034, Spain

Location

GSK Investigational Site

Pamplona, 31008, Spain

Location

GSK Investigational Site

Santiago de Compostela, 15706, Spain

Location

GSK Investigational Site

Bangkok, Thailand

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

casopitant

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2006
• First Posted: June 6, 2006
• Study Start: March 1, 2006
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: March 23, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

BE (4); HK (4); TH (1); PH (2); US (25); RU (5); DE (10); CA (4); CZ (6); PA (1); ES (8)