Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00600990




Registration number
NCT00600990
Ethics application status
Date submitted
15/01/2008
Date registered
25/01/2008
Date last updated
20/01/2017

Titles & IDs
Public title
Study Of An NK-1 Anti-Emetic Medication For The Prevention Of Post-Operative Nausea And Vomiting In Female Patients
Scientific title
Phase II Multicenter, Dose Ranging Study on the Safety and Antiemetic Efficacy of One Day Intraveous Dosing of GW597599 Administered With Ondansetron HCL in a Female Subjects Undergoing Surgical Procedures of High Emetogenic Risk
Secondary ID [1] 0 0
NKO101287
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Nausea and Vomiting 0 0
Nausea and Vomiting, Postoperative 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GW597599

Treatment: Drugs: GW597599
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The number of subjects who achieve a complete antiemetic response during the first 24 hour evaluation period following the emergence from anesthesia.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
The number of subjects who achieve a complete antiemetic response during each subsequent 24 hour evaluation period (up to 120 hours) following the emergence from anesthesia.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- known risk factors for PONV.

- Undergoing gynecological or gallbladder surgery.
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2006
Sample size
Target
Accrual to date
Final
624
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - St Leonards
Recruitment hospital [2] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [3] 0 0
GSK Investigational Site - Carlton
Recruitment hospital [4] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [5] 0 0
GSK Investigational Site - Ringwood East
Recruitment hospital [6] 0 0
GSK Investigational Site - Subiaco
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3186 - Carlton
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3128 - Ringwood East
Recruitment postcode(s) [6] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles
Country [12] 0 0
Belgium
State/province [12] 0 0
Gent
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Nova Scotia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Prince Edward Island
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Canada
State/province [19] 0 0
Saskatchewan
Country [20] 0 0
Chile
State/province [20] 0 0
Región Metro De Santiago
Country [21] 0 0
Czech Republic
State/province [21] 0 0
Brno
Country [22] 0 0
Czech Republic
State/province [22] 0 0
Jihlava
Country [23] 0 0
Czech Republic
State/province [23] 0 0
Olomouc
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Ostrava - Poruba
Country [25] 0 0
Finland
State/province [25] 0 0
Helsinki
Country [26] 0 0
Finland
State/province [26] 0 0
Kuopio
Country [27] 0 0
Netherlands
State/province [27] 0 0
Roosendaal
Country [28] 0 0
Netherlands
State/province [28] 0 0
Rotterdam
Country [29] 0 0
Poland
State/province [29] 0 0
Poznan
Country [30] 0 0
Poland
State/province [30] 0 0
Warszawa
Country [31] 0 0
South Africa
State/province [31] 0 0
Arcadia, Pretoria
Country [32] 0 0
South Africa
State/province [32] 0 0
Bloemfontein
Country [33] 0 0
Turkey
State/province [33] 0 0
Istanbul
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Essex
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Northamptonshire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the effectiveness of this medication in preventing
nausea and vomiting in female patients at risk for post-operative nausea and vomiting (PONV).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00600990
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00600990