Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: April 13, 2005
Last updated: April 14, 2015
Last verified: April 2015
This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both safety and effectiveness in prevention PONV

Condition Intervention Phase
Postoperative Nausea and Vomiting
Nausea and Vomiting, Postoperative
Drug: intravenous ondansetron
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, and no premature discontinuation from the study) during the first 24 hour evaluation period following emergence from anesthesia

Secondary Outcome Measures:
  • Number of subjects who achieve a complete response during each subsequent 24 hour evaluation period (up to 120 hours)following the emergence from anesthesia
  • The extent of nausea experienced by subjects.

Enrollment: 701
Study Start Date: October 2004
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Detailed Description:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Oral Neurokinin-1 Receptor Antagonist, GW67969, When Administered With Intravenous Ondansetron Hydrochloride for the Prevention of Post-Operative Nausea and Vomiting (PONV) and Post-Discharge Nausea and Vomiting (PDNV) in Female Subjects With Known Risk Factors for PONV Who Are Undergoing Surgical Procedures Associated With an Increased Emetogenic Risk

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Females age 18-55
  • Laparoscopic/laparotomic gynecological procedure of laparoscopic gallbladder removal

Exclusion criteria:

  • Pregnant or breastfeeding
  • Post-menopausal
  • Not undergoing general anesthesia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00108095

  Show 58 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00108095     History of Changes
Other Study ID Numbers: NKT102260 
Study First Received: April 13, 2005
Last Updated: April 14, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
post operative nausea and vomiting

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents processed this record on January 14, 2017