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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00108095
Collaborator
(none)
701
Enrollment
58
Locations
10
Duration (Months)
12.1
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: intravenous ondansetron
 Phase 2

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

Study Design

Study Type:
Interventional
Actual Enrollment :
701 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
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, GW679769, 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
Study Start Date :
Oct 1, 2004
Actual Primary Completion Date :
Aug 1, 2005
Actual Study Completion Date :
Aug 1, 2005

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes 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

Locations

Site City State Country Postal Code
1 GSK Investigational Site Montgomery Alabama United States 36106
2 GSK Investigational Site Phoenix Arizona United States 85032
3 GSK Investigational Site Arcadia California United States 91007
4 GSK Investigational Site Duarte California United States 91010
5 GSK Investigational Site Glendale California United States 91206
6 GSK Investigational Site Laguna Hills California United States 92653
7 GSK Investigational Site Loma Linda California United States 92354
8 GSK Investigational Site Pasadena California United States 91109
9 GSK Investigational Site San Diego California United States 92123
10 GSK Investigational Site Stanford California United States 94305
11 GSK Investigational Site Naples Florida United States 34108
12 GSK Investigational Site Pensacola Florida United States 32504
13 GSK Investigational Site Alpharetta Georgia United States 30005
14 GSK Investigational Site Hutchinson Kansas United States 67502
15 GSK Investigational Site Kansas City Kansas United States 66160
16 GSK Investigational Site Baton Rouge Louisiana United States 70806
17 GSK Investigational Site Baltimore Maryland United States 21229-5299
18 GSK Investigational Site Jackson Mississippi United States 39202
19 GSK Investigational Site New Brunswick New Jersey United States 8903
20 GSK Investigational Site New York New York United States 10016
21 GSK Investigational Site New York New York United States 10025
22 GSK Investigational Site Winston-Salem North Carolina United States 27103
23 GSK Investigational Site Pittsburgh Pennsylvania United States 15213
24 GSK Investigational Site Charleston South Carolina United States 29425
25 GSK Investigational Site Houston Texas United States 77024
26 GSK Investigational Site Houston Texas United States 77030
27 GSK Investigational Site Houston Texas United States 77054
28 GSK Investigational Site San Antonio Texas United States 78240
29 GSK Investigational Site Winchester Virginia United States 22601
30 GSK Investigational Site Wenatchee Washington United States 98801
31 GSK Investigational Site Aalst Belgium 9300
32 GSK Investigational Site Braasschaat Belgium 2930
33 GSK Investigational Site Bruxelles Belgium 1020
34 GSK Investigational Site Calgary Alberta Canada T2N 2T9
35 GSK Investigational Site Edmonton Alberta Canada T5H 3V9
36 GSK Investigational Site Vancouver British Columbia Canada V5Z 3C6
37 GSK Investigational Site Vancouver British Columbia Canada V6Z 1Y6
38 GSK Investigational Site Saint John's Newfoundland and Labrador Canada A1B 3V6
39 GSK Investigational Site Halifax Nova Scotia Canada B3K 6R8
40 GSK Investigational Site Hamilton Ontario Canada L8N 3Z5
41 GSK Investigational Site London Ontario Canada N6A 4G5
42 GSK Investigational Site London Ontario Canada N6A 4V2
43 GSK Investigational Site Toronto Ontario Canada M5T 2S8
44 GSK Investigational Site Montreal Quebec Canada H3A 1A1
45 GSK Investigational Site Sherbrooke Quebec Canada J1H 5N4
46 GSK Investigational Site Ste-Foy Quebec Canada G1V 4G2
47 GSK Investigational Site Quebec Canada G1L 3L5
48 GSK Investigational Site Marburg Hessen Germany 35043
49 GSK Investigational Site Aachen Nordrhein-Westfalen Germany 52074
50 GSK Investigational Site Koblenz Rheinland-Pfalz Germany 56073
51 GSK Investigational Site Győr Hungary 9023
52 GSK Investigational Site Kistarcsa Hungary 2143
53 GSK Investigational Site Miskolc Hungary 3529
54 GSK Investigational Site Székesfehérvár Hungary 8001
55 GSK Investigational Site Cadiz Spain 11009
56 GSK Investigational Site Cartagena Spain 30203
57 GSK Investigational Site Madrid Spain 28034
58 GSK Investigational Site Santiago de Compostela Spain 15706

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00108095
Other Study ID Numbers:
  • NKT102260
First Posted:
Apr 14, 2005
Last Update Posted:
Jan 20, 2017
Last Verified:
Jan 1, 2017
Keywords provided by GlaxoSmithKline
emesis
nausea
post operative nausea and vomiting
vomiting
PONV
Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Ondansetron

Study Results

No Results Posted as of Jan 20, 2017