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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00108095
First received: April 13, 2005
Last updated: November 21, 2012
Last verified: November 2012

April 13, 2005
November 21, 2012
October 2004
Not Provided
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
To assess the number of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, and no premature discontinutation from the study) during the first 24 hour evaluation period following emergence from anesthesia.
Complete list of historical versions of study NCT00108095 on ClinicalTrials.gov Archive Site
  • 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.
  • 1)To assess the number of subjects who achieve a complete response during each subsequent 24 hour evaluation period (up to 120 hours) following the emergence from anesthesia.
  • 2)The extent of nausea experienced by subjects during the 2,6, and 24 evaluation periods, by Likert scale.
  • 3)The extent of nausea experienced by subjects daily at each subsequent 24 hour evaluation period (up to 120 hours) by Likert scale.
  • 4)Safety assessments, incl routine physical exam, vital signs, ECG, labs, AE reporting.
  • 5)Quality of life assessment.
  • 6)Subject satisfaction with treatment.
  • 7)Assessment of post op pain.
  • 8)PK and PD parameters.
Not Provided
Not Provided
 
A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting
See Detailed Description

This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both safety and effectiveness in prevention PONV

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Postoperative Nausea and Vomiting
  • Nausea and Vomiting, Postoperative
Drug: intravenous ondansetron
Other Name: intravenous ondansetron
Not Provided
Singla NK, Singla SK, Chung F, Kutsogiannis DJ, Blackburn L, Lane SR, Levin J, Johnson B, Pergolizzi JV Jr. Phase II study to evaluate the safety and efficacy of the oral neurokinin-1 receptor antagonist casopitant (GW679769) administered with ondansetron for the prevention of postoperative and postdischarge nausea and vomiting in high-risk patients. Anesthesiology. 2010 Jul;113(1):74-82. doi: 10.1097/ALN.0b013e3181d7b13a.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
665
Not Provided
Not Provided

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
Female
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Germany,   Hungary,   Spain
 
NCT00108095
NKT102260
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP